Director, Pharmacovigilance

Found in: Talent US C2 - 2 weeks ago

Remote, United States The Steely Group Full time

The Director of Pharmacovigilance (DPV) leads and/or oversees safety and benefit-risk management for assigned product(s), management of potential safety issues, identification of signals and their evaluation, and other activities such as drafting responses to regulatory inquiries on product safety issues for assigned product(s). The DPV works closely with the Global Safety Physician (GSP) and other colleagues within the Medical Risk Management (MRM) team for all deliverables related to benefit-risk management of assigned product(s). The DPV serves as a subject matter expert for MRM and cross-functional teams on product-specific safety information, data output and analyses, and relevant global safety regulations and guidelines.

In collaboration with the GSP, the DPV will have the following specific responsibilities:
  • Leads and/or oversees the signal detection and management (i.e., routine signal detection reports, tracking, review meetings, signal assessments, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing PV activities.
  • Coordinates, contributes and presents at safety governance meetings (e.g. Safety Management Teams, Executive Safety Committee, Signal Management and Review Team Meetings, etc.).
  • Filing and maintaining GVP documentation including meeting minutes and materials for appropriate GXP recordkeeping activities and filing responsibilities.
  • Authors and/or oversees the authoring of aggregate reports (i.e., DSUR, PBRER, PADER, etc.) for assigned product(s).
  • Supports process improvement initiatives, inspection readiness activities and participates in inspection or audit-related activities for assigned product(s) and/or MRM responsibilities.
  • Coordinates with international and cross-functional teams responsible for collaborating on safety decisions for assigned product(s) in development and post-approval.
  • Contributes to and/or reviews documents related to clinical trial safety, post-marketing safety, regulatory submissions, and labeling.

Requirements / Qualifications:
  • Medical Science qualifications: Medical Degree, Pharmacy degree, Nursing degree (BS, MS), or MS in health-related field.
  • At least 10 years of biotech/pharmaceutical industry experience, including at least 8+ years of experience in drug safety serving as a PV Scientist or similar role. Relevant experience in the Gastrointestinal therapeutic and/or rare disease area a plus. Experience collaborating with global business partners and/or vendors a plus.
  • Experience with MedDRA coding, safety databases, and clinical trial databases.
  • Experience with leading the development, authorship, and review of aggregate reports and/or key safety-related documents (i.e., DSUR, IND annual report, PBRER, PADER, RMPs, REMS).
  • In-depth knowledge of global post-marketing and clinical trial safety regulations, guidances, and reporting processes. Experience with a post-marketed product with ongoing clinical development a plus.

Competencies:
  • Ability to recognize opportunities and/or issues and apply analytical and creative thinking to maximize performance.
  • Ability to focus on delivering excellent results and improving the performance of oneself and of the client by taking initiative to try new approaches, while still following the rules (e.g., company, government and ethical), by taking action to surpass one’s own past performance, excel at an objective measure or goal, or do something that has never been done before.
  • Ability to leverage a deep understanding of oneself through knowing one’s strengths and weaknesses, proactively asking for feedback to balance self-perception, and being resilient in order to increase one’s effectiveness.
  • Ability to work cooperatively with colleagues and take initiatives to build relationships despite differences in interest, offering support and help to peers without being asked or proactively seeking input from others to solve problems.
  • Ability to successfully lead, mentor, and manage a team of colleagues and/or direct reports.
  • Excellent verbal and written communication skills with the ability to present complex information effectively.
  • Strong organizational skills with the ability to re-prioritize and adapt to a fast-moving environment.

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