Job Title: Executive Director / VP Pharmacogivilance
Job Number: 30116
The Exec Director / Vice President of Pharmacovigilance will be responsible for leading the pharmacovigilance and drug safety function within the organization including supervising key pharmacovigilance personnel. You will work with key stakeholders within the organization to develop PV strategy for Gossamer products under development including proactively identifying and communicating emerging potential and/or urgent safety issues and to support signal detection and risk/benefit evaluation. You will have oversight of Serious Adverse Event (SAE) processing and ensure timely, compliant, and accurate safety reporting in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and standard operating procedures (SOP). The role requires both a “hands on” and a strategic mind-set.
- Develop overall risk management plans, pharmacovigilance strategies, risk minimizations activities, and contribute to the assessment of risk/benefit for drugs in development
- Main point of contact for business partners and regulatory inspection auditors
- Implementation and maintenance of Safety Data Exchange agreements with potential partners
- Maintain safety inspection preparedness
- Ensure compliance with GVP, GCP, GMP and all applicable regulations
- Oversee, prepare, and review scheduled periodic/annual reports (FDA) and Periodic Safety Update Reports (FDA and Rest of World [ROW])
- Contribute to INDs, IMPDs, and other regulatory submissions
- Review and provide input to protocols, Investigators brochures (IBs), clinical safety reports (CSRs), Informed consents (ICFs) and other safety-related documents
- Support regulatory interactions with the FDA, EMEA, and other regulatory authorities
- Formulates responses to requested Health Authority inquiries with information relevant to product safety
- Recognize and escalate significant issues relating to compliance, budgets, timelines or other issues that may jeopardize business objectives
- Develop and maintain SOPs as needed and ensure compliance
- Provide analysis and oversight for generation of Analysis of Similar Events (AOSE) statement for IND safety reporting
- Manage interactions with Safety Review Committees in relevant studies, providing input and collaboration regarding DMC charter
- Management and approval of budgets/contracts
- Have talent management and professional development responsibilities for key personnel in the PV functional area
- MD preferred; PhD in related life science area may be considered depending on breadth and depth of pharmacovigilance experience
- Minimum of 7+ years of Drug Safety/Pharmacovigilance experience in a pre-approval setting required with Immunology / Immuno-oncology expertise.
- Minimum of 10+ years of direct experience in Clinical Safety, Pharmacovigilance, and risk management within the pharmaceutical industry characterized by positions of increasing responsibility with experience in managerial oversight.
- Demonstrated leadership skills
- Experience in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents
- Strong knowledge of GCP, ICH, and Global regulations
- Excellent communication, writing, and analytic skills
- Ability to work independently and with a team; collaborating and often contributing to discussions amongst internal teams; work effectively without a lot of support or structure.
- Ability to apply expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Thorough understanding of clinical methodologies and providing sound analytical support; quickly establish credibility as a reliable resource.
- Office environment / Domestic and International travel up to 20% may be necessary