Director, Medical Safety Science (Risk Management)

Gilead Sciences
Belmont, CA
Closing date
Sep 26, 2021

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Science, Pharmaceutical, Pharmacovigilance
Job Description
Specific Responsibilities:
• Signal detection and authorship of signal work-up documents in collaboration with a Medical Safety Science Medical Evaluation (MSS-ME) team member
• Authorship of Company Core Data Sheet (CCDS) sections and associated supporting documentation
• Authorship of aggregate safety reports (e.g. PSURs)
• Authorship of risk management plans
• Authorship of responses to regulatory agency safety enquiries
• Contribution to safety analyses in Regulatory submissions (e.g. Marketing Authorisation Application (MAAs), New Drug Application (NDAs))
• May participate in literature review process on an ad hoc basis
• Safety review of clinical trial protocols, investigator brochures, study reports, informed consent forms, and other study related documents for assigned studies
• Reviews standard reference documents in collaboration with a MSS-ME team member
• Collaborates with partner companies on safety evaluation for co-licensed products
Essential Duties and Job Functions:
• Chairs cross functional safety committee meetings (internal or with partner companies); able to present complex information clearly
• Ensures timely review of protocols, informed consents and other study related documents for multiple products and therapeutic areas
• Participates on and may lead various cross-functional teams, involving interaction with Gilead staff within and external to GLPS, to convey and acquire drug safety information internally and externally
• Directs highly complex communications and ensures that all customers are fully informed and knowledgeable of project activities and their status
• May recruit, hire, and manage direct reports, with responsibility for employee performance evaluations
• Contributes to audits/inspections of systems and procedures to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting regulations, including authoring of responses to findings relevant to functional area
• Participates in both internal and external educational initiatives
• May participate in budget planning and management
Knowledge, Experience and Skills:

• Demonstrates proficiency in verbal and written communication, including Microsoft Excel, Word, and Power Point
• Demonstrates excellent attention to detail, teamwork and initiative; maintains confidentiality; maintains meticulous attention to project deadlines
• Able to work independently, establishing work priorities and direction
• Demonstrates excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
• Sufficient skill and confidence to make significant contributions to strategic planning within the GLPS and epidemiology department
• Demonstrates good understanding of observational studies used in pharmacoepidemiology and ability to provide a sound critique of such studies
• Typically requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a health science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline with demonstrated experience with the responsibilities, deliverables, and skills required for this level
• Extensive experience (7+ years) in pharmacovigilance is required

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