Full-Time Director-Global Safety Lead-Pharmacovigilance
The Director, Global Pharmacovigilance will function as the Global Safety Leader (GSL) for an assigned portfolio of products in development and marketed products.
The Global Safety Lead is a senior drug safety expert (physician), who will be responsible for and recognized as the go-to person for the safety strategy throughout the product lifecycle for assigned marketed and development products (‘assigned products’). He/she will maintain current knowledge of full product portfolio, and for the assigned products. He/she will have accountability for safety surveillance, risk management, risk communication, medical assessment of individual adverse event reports, the generation and review of aggregate reports, risk management plans (including REMS) and other safety documents, including labeling changes. The Global Safety Lead will collaborate with the VP of Safety & EU QPPV to develop the strategic roadmap for managing the benefit risk profile of assigned products. The GSL will serve on relevant inter-departmental teams representing Global Pharmacovigilance in the Medical Department.
•Position leads SMTs and is a recognized product safety expert for assigned Phase 1 and 2a products. Oversee ongoing safety of Phase 3 studies as lead CS physician and serve as the Clinical Safety PV (CSPV) functional representative at Global multifunctional project team meetings.
•This position prepares, summarizes, and reviews aggregate safety analyses. Additionally, this position develops and implements integrated project/product risk management strategies and drafts the Risk Management Plan with Level III. This position performs safety assessments and determines the safety profiles of assigned products.
•This position also works with other CSPV staff and SMT members and serves as the CSPV representative on TR-PT/IPT on Phase 1 and 2a products. This position may review and approve safety documents. Finally, this position also handles moderately complex safety matters, such as CSPV’s preliminary proposal for safety monitoring in Phase 2 study with well-known AESI, with manager support.
•Medical safety review of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the product life cycle for assigned products. Medical review of adverse event reports includes assessment for seriousness, expectedness, appropriate coding and causality; deciding on necessary follow-up queries for individual cases.
•Conducting signaling activities, including monitoring, evaluation, interpretation, management and communication of safety information
•Leading the Product Safety Teams for assigned products and managing benefit-risk profiles along with the related actions, including writing and updating of the benefit-risk documents for assigned products and development compounds
•Medical expert safety review of and input into all critical documents for assigned products in clinical development (e.g., protocols and -amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs, DSURs)
•Collaborate with the Head of Safety to develop and implement the strategy for benefit-risk management for assigned products.
•Author important medical content of Risk Management documents (e.g., RMPs, REMS)
•Writing of periodic reports for assigned products and providing medical interpretation, review and approval for required reports where applicable
•Providing expert safety input into clinical development programs for assigned products
•Ensuring, in collaboration with Regulatory Affairs labeling review team an accurate representation and communication of the safety profile of assigned products by
•in the Product’s Reference Safety Information, including the Company Core Safety Information (CCSI), the Investigator Brochure, and local labeling documents
•Providing the medical safety content for responses to inquiries from regulatory authorities related to safety topics and integrated safety input into any applicable regulatory documents where required
•Providing Drug Safety input for individual product quality complaints, aggregate product quality associated Health Hazard Evaluations, product recall issues and Dear Healthcare Professional letters/communications
•Reviewing of scientific literature for assigned products, identifying case reports that meet criteria for entry into the safety database; identifying relevant safety articles / references involving the active ingredients of the assigned products; and creating literature summary sections for PBRERs/PSURs and other required reports.
•Representing Global Drug Safety on leadership committees and related activities both internally and externally as required.
•Communicating effectively regarding product safety issues and proposing solutions where they may impact the benefit-risk profile of assigned products with Senior Leadership, including the office of the EU QPPV via the appropriate channels
•Developing and maintaining strong relationships and sharing drug safety and general medical expertise within assigned therapeutic areas with other stakeholders including Clinical Development Teams, Regulatory Affairs, Licensing and Marketing to better understand and fully support business objectives.
•Providing applicable medical safety input to clinical team decisions
•Participating in inspection readiness activities as it pertains to assigned products and PV related activities for assigned products
•Continuously accruing therapeutic area knowledge to allow for ongoing safety assessment within the therapeutic area, including competitive products and therapies.
Department specific/Non-essential responsibilities:
•Attending seminars on global Pharmacovigilance and Safety
• Other activities, as needed or as requested by manager.
• In-depth understanding including industry-wide best practices for pharmacovigilance functions relevant to Global Medical Safety.
Experience / Skills:
•Health care professional with post graduate medical qualification (MD/DO or equivalent)
•A minimum of 8-12 years clinical/practical experience in a relevant clinical environment. A minimum of 2 years of Pharmacovigilance experience in Clinical Safety or Post-Marketing Safety including thorough knowledge of FDA and ICH safety reporting regulations and guidelines. Any experience with regional, national and global regulatory authority is a plus.
•Strong oral and written communication skills
•Advanced analytical skills
•Sound medical judgment and decision making capabilities
•Strategic thinking and facilitative leadership
•Fluent utility of office computer programs such as Excel, Word, and PowerPoint
•Sound organizational and prioritization skills
•Formal training in Epidemiology a plus
•Demonstrated skills for project management
• Safety Surveillance expert
• Risk Management / communication
• Medical assessment
• Product Safety Leadership Expert
• Clear and Concise Communication
Director, Global Pharmacovigilance (Global Safety Leader) reports directly to the Vice President, Global Pharmacovigilance.
Direct Reports: None
Interact with: Legal Affairs, Regulatory Affairs, and R & D, IS, Sales and Marketing and other groups with varying degree and scope.
Working conditions: normal office setting.
Location: Bedminster, NJ
Travel: Occasional for training, professional conventions, corporate meetings.
How to Applyhttps://mallinckrodt.wd5.myworkdayjobs.com/en-US/MallinckrodtCareers/job/US-Specialty-Brand-Headquarters---USA501/Director---Global-Safety-Lead---Pharmacovigilance_JR000009988
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