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Gilead

Associate Director, Pharmacovigilance & Epidemiology - Risk Management

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Specific Responsibilities:
  • Authors of Risk Management Plans (RMPs) and Development RMPs for cellular therapy products
  • Participates in development of strategies for routine and additional risk minimization and PV measures, as applicable, in collaboration with Pharmacovigilance & Epidemiology Physicians
  • Contributes to development and execution of Risk Evaluation and Mitigation Strategy (REMS), including the associated Elements to Assure Safe Use (ETASU), as applicable
  • Provides scientific and strategic input in development and execution of Post Authorization Safety Studies (PASSs), including Long-term follow up/Registry studies
  • Participates in or may lead cross-functional teams (e.g., Working Groups, Committees, etc.), involving interactions with Kite/Gilead staff within and external to PVE, to ensure timely advancement of deliverables and submission to health authorities as required
  • Authors responses to safety enquiries received from global regulatory agencies
  • Supports regulatory filing activities including analyses of aggregate safety data, review of filing documents (e.g., CSRs, ISSs, etc.)
  • Reviews draft periodic reports (e.g., PSUR/PBRER, PADER, DSUR, etc.); may author relevant sections as needed
  • Offers significant contributions to discussions at safety governance meetings (e.g., SMT, etc.), as applicable, for cellular therapy products
  • Presents results and findings from risk management activities (e.g. RMP, REMS, etc.) and applicable processes in formal settings as needed
  • Leads multiple projects simultaneously with minimal supervision
  • Leads the analysis and resolution of complex problems collaboratively with cross-functional staff
  • Establishes recognition within PVE as an expert in pharmacovigilance
  • Anticipates complex problems which may arise and resolves them in a collaborative manner

Minimum Qualifications:

  • BS, BA, MSc or PhD or professional qualification in a health science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline (e.g., oncology, cellular therapy, etc.) with demonstrated experience with the responsibilities, deliverables, and skills
  • 8+ years in the pharmaceutical or biotech industry
  • 6+ years of direct experience in PV/Risk Management
  • Demonstrated knowledge of pharmacovigilance regulations, risk management plans, risk minimization/PV measures, signal detection, clinical trials and clinical development
  • Proven effective verbal and written communication and proficiency with Microsoft Office, Excel, Word, and PowerPoint
  • Demonstrates excellent attention to detail, project management skills, teamwork and initiative; maintains meticulous attention to project deadlines
  • Ability to influence others at all levels of the organization in a complex, matrixed environment
  • Demonstrates ability to assess complex data sets and understand the safety/medical implications
  • Working knowledge of observational studies used in pharmacoepidemiology


For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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