Duties and Responsibilities
- Lead the Safety Management Team and direct all safety risk management activities for assigned products.
- Ensure local and global risk management plan preparation and execution throughout a medicinal product’s lifecycle.
- Formulate clinical trial and postmarketing risk management safety strategies that are in alignment with the company's drug development and commercialization strategies.
- Perform drug safety signal detection activities for Incyte’s portfolio of investigational and marketed products; develop medically reasonable evaluations of safety signals; and make specific, actionable, and defensible recommendations for confirmation or refutation of safety signals.
- Manage and monitor benefit-risk evaluations to ensure favorable benefit-risk balance.
- Medically review ICSRs and provide follow-up guidance to Case Operations team to ensure consistent high-quality reports.
- Review emerging literature regarding Incyte products, as well as relevant products from collaboration partners, to identify new and important information that potentially impact human safety; conduct reviews both independently within Incyte and in conjunction with external collaboration partners.
- Drive preparation of IND Annual Reports and/or DSURs for Incyte clinical trial programs, and PADERs and/or PSUR/PBRERs for marketed products.
- Perform Health Hazard Evaluations.
- Participate significantly in the development and production of integrated summaries of safety, clinical overviews, and other registration documents for new and supplemental NDAs and/or ex-US new drug submissions/variations for late-phase drug development candidates and marketed products in conjunction with Clinical Development, Medical Writing, Statistics, and Regulatory Affairs.
- Drive the safety strategy for Reference Safety Information for Incyte products, including Investigator Brochures and new or updated labeling (USPI, SmPC, or CDS) for marketed products in the context of multidisciplinary groups within Incyte or joint committees between external partners.
- Participate in internal safety process improvements and updates, including new means of effective presentation of early phase clinical study status reports with regard to safety findings.
- Contribute to preparedness for regulatory authority inspection and internal audits of Pharmacovigilance, and contribute to the development and implementation of any preventative and/or corrective action plans as they pertain to specific identified deficiencies of policy, procedure, or practice in GRMSS.
- Review medical and safety content included in standard response letters prepared by Medical Affairs, as necessary, and work with Medical Affairs to create and periodically revise standard communications that include specific adverse event information.
- Champion risk management safety strategy to internal (eg, Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Translational & Experimental Medicine and Legal) and external (eg, regulators and commercial collaborators) stakeholders.
- Serve as the GRMSS medical representative for joint clinical development programs with external partners as required.
- Other responsibilities, as necessary.
- In the absence of the EU/UK QPPV, the GRMSS physician (or their back-up) is responsible for responding to product-related queries as delegated by the EU/UK QPPV.
Requirements
- M.D. or US/international equivalent.
- 5-10 years total pharmaceutical/biotechnology industry or regulatory agency experience, of which more than 5 years will have been in a pharmacovigilance or risk management role.
- In-depth knowledge of US/EU risk management/GVP landscape.
- First-hand experience interacting with regulators with risk management issues.
- Experience as an active contributor with drug registrations (Clinical Study Reports, Integrated Summaries of Safety, Summaries of Clinical Safety, and Clinical Overviews).
- M.P.H. or relevant epidemiology experience in industry or academia preferred.
- Board certification in internal medicine or pediatrics (primary care) or hematology/oncology (specialty) preferred.
- Experience in pharmaceutical industry activities required outside the United States preferred.
- Experience in clinical trial development and execution preferred.
- Training or experience in oncologic or inflammatory diseases, or relating to clinical safety support of oncology, immunomodulatory, or other related products preferred.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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