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Quality Assurance Senior QA Officer Full time Leiden 1098 Our Culture Pharming is committed to our core values: “We Care, We Collaborate, We Walk the Talk”, which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives. Purpose of the role As a Senior QA Officer at Pharming, your primary responsibility is to ensure the compliance of the quality systems at Pharming, external partners, and contractors with EU and USA GMP legislation, guidelines, and Pharming's quality expectations. In this crucial role, you will provide expert advice to employees and managers on QA-related matters. You advise employees and managers on QA related matters and evaluates, analyzes and prepares pharmaceutical related documents needed for batch release and compliance to GMP. Areas of Responsibility Write, implement, review and maintain SOPs, policies and other QA related documentation in alignment with applicable GxP guidelines. Identify documents which need to be created or updated and ensure this is organized. Act as trainer and expert for other Quality Assurance Officers. Organize meetings with BME and/or Pharming departments to ensure problem resolution and conducting investigations associated with deviations, Change Controls, CAPA’s, Risk Assessments, protocols and reports. Review, analyze and prepare documentation related to commercial starting material production, including batch records, specifications and certificates to ensure compliance with applicable guidelines and procedures. Identify and communicate areas for improvement. Initiates, formulates and implements new processes and procedures within area of expertise. Communicate and negotiate with contractors and suppliers, with respect to deviations, audits and complex projects. Proactively propose ideas for site improvements; and provide subject matter expert reports as required. Performing and reviewing internal and external audits, as lead auditor, to determine compliance with applicable guidelines (like GMP, GLP, ISO, GDP, GCP). Represents QA dept in significant complex projects. Knowledge: BSc Biotechnology, chemistry, biopharmaceutics or equivalent Experience: Six years of experience in (bio)pharmaceutical environment with at least four years in Quality Assurance. What you'll get in return We offer you a permanent position (starting with a one-year contract), with an excellent remuneration scheme, including: A highly competitive salary 8.33% holiday allowance (for NL) A minimum of 30 vacation days An excellent pension plan Commuting allowance You will also join our Learning & Development program, which can offer a tailor made development plan, based on your personal and professional needs. Learning opportunities are everywhere, in all forms imaginable and we want to create learning memories for all “Pharmers”. Also important! We truly value a healthy life-work balance with a lot of flexibility. Apply for the job Does this sound like you and do you want to join our team? Then we'd love to hear from you! We’re an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Finance ESG Reporting Manager Leiden Full time 1050 About Pharming Pharming Group N.V. (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific. Our Culture Pharming is committed to our core values: “We Care, We Collaborate, We Walk the Talk”, which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives. Purpose of the role: The ESG Reporting Manager, will be responsible for developing, managing, and enhancing our Environmental, Social, and Governance (ESG) reporting initiatives. He / she will collaborate with various departments to collect and analyze ESG data, prepare comprehensive reports, and drive transparency and accountability in our ESG performance. As the ESG Reporting Manager, he / she will play a pivotal role in helping the company meet its reporting requirements on its sustainability goals and communicate its efforts to stakeholders effectively. He / She will also act as a back-up for the financial accountant. Responsibilities: ESG Data Collection and Analysis: Oversee the collection of ESG data from different departments and external sources. Analyze ESG data to identify trends, performance indicators, and areas for improvement. Develop methodologies for data verification and validation. Reporting Frameworks: Stay up-to-date with evolving ESG reporting standards and frameworks (e.g., GRI, ESRS, CSRD). Ensure compliance with industry-specific regulations and guidelines. Develop and maintain a reporting framework tailored to the organization's needs. Sustainability Reporting: Lead the preparation of periodic ESG reports, including annual sustainability reports and other ad-hoc reports as required. Coordinate with internal and external stakeholders to gather relevant information and insights for reporting purposes. Ensure the reports are accurate, clear, and transparent in their presentation of ESG performance. Data Management: Develop and maintain a robust ESG data management system. Ensure data accuracy, consistency, and accessibility for reporting purposes. ESG Strategy and Goal Alignment: Collaborate with cross-functional teams to align ESG strategies with the organization's mission, values, and long-term goals.\Support the development and monitoring of ESG performance targets and objectives. Training and Awareness: Occasionally provide ESG training and awareness programs for employees, enabling them to contribute to the company's sustainability goals. Promote a culture of ESG awareness and responsibility within the organization. Back-up for Financial Accountant: Periodic consolidating the financial reports of Pharming Group N.V. and its subsidiaries. Contribute to the preparation of the Annual Report, IFRS Financial Statements and other related matters such as press releases. Contribute to the preparation of position papers for accounting matters and valuation. Your profile: Master’s degree in a relevant field (Finance, Accounting, or Similar); 5-10+ years of proven experience in Finance / Accounting and Reporting; 3+ years of proven experience in a similar (ESG related) role; Working experience in a multinational, multicultural, stock-listed company; Strong communication skills; Fluent in English both in word and writing, and preferably one other language; Basic knowledge of IFRS and consolidation requirements; Familiar with SOx and the administrative documentation of the work performed; Project management experience is a plus; Professional certifications in ESG reporting or sustainability are a plus. Proficiency in ESG reporting standards and frameworks; What you'll get in return We offer you a permanent position (starting with a one-year contract), with an excellent remuneration scheme, including: A highly competitive salary 8.33% holiday allowance (for NL) A minimum of 30 vacation days An excellent pension plan Commuting allowance You will also join our Learning & Development program, which can offer a tailor made development plan, based on your personal and professional needs. Learning opportunities are everywhere, in all forms imaginable and we want to create learning memories for all “Pharmers”. Also important! We truly value a healthy life-work balance with a lot of flexibility. Apply for the job Does this sound like you and do you want to join our team? Then we'd love to hear from you! We’re an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Human Resources Global HRIS Project Manager US (Consultant) Full time Warren 1101 Pharming Group N.V. (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific. Our Culture Pharming is committed to our core values: “We Care, We Collaborate, We Walk the Talk”, which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives. Overview The Global HRIS Project Manager (Consultant) – SAP SuccessFactors oversees and monitors all aspects of the global HRIS implementation project according to the best project management methodologies and governance. Responsibilities include but are not limited to setting deadlines, assigning responsibilities, and monitoring progress of the project. Working with functional teams in HR to collect requirements, define tasks, create schedules, manage vendor deliverables and costs. Driving results by utilizing project management tools and protocols to align practices and leverage cross functional resources for successful project delivery. Key Responsibilities The Global HRIS Project Manager (Consultant) – SAP SuccessFactors will be responsible for a wide variety of matters in support of Pharming’s growth as we increase the number of both pipeline and marketed products. Core functions include: Responsible for project deliverables, ensuring the project is on time and on budget with appropriate quality. Act as Single Point of Contact for all project team members and stakeholders to ensure a close productive relationship between all people involved in the project and flawless execution. Perform risk assessment analysis and weights the impact on the project and business. Writing project plans and keeps track of the progress. Reports project status, including timelines, budget, and risk analysis to the project sponsor. Documenting all relevant project information, as well as creates and maintains a comprehensive project documentation in a methodical and secure way. Work accordingly with the best project management practices. Designing and overseeing the execution of change management strategies to facilitate adoption of the system change. This is a remote role; candidate should preferably reside in the US Northeast Coast for the ability to be on-site at the NJ office for workshops, etc. Must have the ability to travel up to 20%. Minimum Qualifications: Bachelor’s degree in Information Technology, Human Resources Management, Business Administration, Engineering, or equivalent education and/or experience. 10+ years of HRIS Implementation experience. Fluent in English (written and spoken). Preferred Qualifications: Experience with SAP SuccessFactors. Strong project management skills: planning, risk management, problem solving, change management, delivering the projects in time/quality/within budget, contingency development. Excellent stakeholder interaction and management. Additional Information Pharming is committed as an Equal Opportunity and Affirmative Action employer for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, genetic information, sexual orientation, marital status, race, religion, color, national origin, disability, protected Veteran status, age, or any other characteristic protected under applicable law. An applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request via email to HR-US@pharming.com. Unsolicited resumes from agencies should not be forwarded to Pharming. Pharming will not be responsible for any fees arising from the use of resumes through this source. Pharming will only pay a fee to agencies if a formal agreement between Pharming and the agency has been established. The Human Resources/Talent Acquisition department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Please note that we review every submission, and we will keep submissions on file for six months.
Medical Affairs Medical Science Liaison Germany - North East Full time DE 1080 About Pharming Pharming Group N.V. (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific. Our Culture Pharming is committed to our core values: “We Care, We Collaborate, We Walk the Talk”, which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives. Purpose of the role: The Medical Science Liaison establishes and maintains relationships with appropriate target physicians, researchers, and clinicians and key opinion leaders (KOLs) to ensure that products are used effectively. The Medical Science Liaison serves as scientific resource and expert, advises on current and upcoming advances in treatments, and provides input about relevant scientific and clinical data. He/she coordinates cross functional LCM strategies and executes medical affairs programs of therapeutic areas at local country (cluster) level. Responsibilities: Develop and maintain long term relationships with local KOLs with a view to supporting IIT/medical project development in therapeutic areas of interest in line with local MA plan. Provide in-depth medical scientific training and support to commercial (marketing and/or non-science) teams in the appropriate territories. Utilize field knowledge and insight to develop and support strategic and tactical objective of therapeutic area. Provides input to EU/US brand strategy. Follow all applicable policies and procedures related to Medical affairs Provide KOL insights and observations to the medical affairs team on a timely basis. Help to ensure that KOL speakers have access to appropriate scientific data. Participate in coordinating and conducting peer-to-peer interactions and medical presentations. Remain up-to-date in appropriate therapeutic areas of focus to Pharming Provide medical support to Pharming’s clinical research programs and registries Where appropriate, provide overall medical / scientific support through the dissemination of on-label educational, scientific, and clinical information on diseases and its treatment, for training purposes only. Where possible, develop relationships with local thought leaders (physicians, pharmacists and nurses) whose opinions and treatment regimens influence the practice of their colleagues. Identify unsolicited requests for investigator-initiated research. In response to appropriate requests, disseminate to physicians, nurses and other healthcare professionals state-of-the-art on-label research and medical concepts related to the treatment and management of diseases of interest to the company. Relay Medical Information requests through appropriate channels. When appropriate, represent Medical Affairs at continuing educational events / programs, medical meetings and scientific conventions. Your profile: KNOWLEDGE: Professional Qualification advantageous eg MD/PhD/PharmD/MSc Strong medical and scientific knowledge with experience of Immunology and/or specialty therapeutic areas advantageous Understanding of the ABPI Code of Practice/EFPIA guidelines (training will be provided) and in-country local code insight advantageous Excellent organisational, project and time management skills Strong command of German and English language (verbal, written) and a further European language would be an advantageous (French, Spanish, Portuguese, Italian) EXPERIENCE: 3+ years in MSL or similar function 5+ years academic and/or biotech/pharmaceutical industry experience Proven success working with local EU operating company models, processes, cultures, languages and functions
Program Management Office Global HRIS Project Manager (consultant) Leiden Full time 1079 About Pharming Pharming Group N.V. (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific. Our Culture Pharming is committed to our core values: “We Care, We Collaborate, We Walk the Talk”, which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives. About the role: Global HRIS Project Manager oversees and monitors all aspects of global HRIS implementation project according to the best project management methodologies and governance. Responsibilities include but are not limited to setting deadlines, assigning responsibilities, and monitoring progress of the project. Working with functional teams in HR to collect requirements, define tasks, create schedules, manage vendor deliverables and costs. Driving results by utilizing project management tools and protocols to align practices and leverage cross functional resources for successful project delivery. Writes project plans and keeps track of the progress Ensures that the project is on time and on budget with appropriate quality Responsible for project deliverables Acts as Single Point of Contact for all project team members and stakeholders to ensure a close productive relationship between all people involved in the project and flawless execution Performs risk assessment analysis and weights the impact on the project and business Reports project status, including timelines, budget and risk analysis to the project sponsor Documents all relevant project information in a methodical and secure way / Creates and maintains a comprehensive project documentation in a methodical and secure way Works according the best project management practice Designs and oversees the execution of change management strategies to facilitate adoption of the system change. Experience Functional Knowledge and expertise Fluent in English (written and spoken) Solid experience in implementing HRIS (SuccessFactors is a preference) globally Strong project management skills: planning, risk management, problem solving, change management, delivering the projects in time/quality/within budget, contingency development Excellent stakeholder management
Stand van de vacatures per 1-1-2024 Aantal openstaand: 22 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 307 Vervuld: 298 2023 Bijgekomen: 123 Afgenomen: 119
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