Vice President, Pharmacovigilance
VICE PRESIDENT, PHARMACOVIGILANCE
Global Blood Therapeutics is seeking a seasoned leader to oversee the overall development of the Pharmacovigilance department - Operations, Risk Management, and Compliance. The Vice President, Pharmacovigilance and Drug Safety will report directly to the Senior Vice President, Clinical Development. The successful candidate is responsible for hands-on leadership for all Pharmacovigilance activities in support of clinical development programs as well as future marketed products.
Essential Duties and Responsibilities:
- Direct and supervise global Pharmacovigilance activities (operations, compliance, systems, and signal and risk management) for products in clinical development
- Provide global strategic Pharmacovigilance expertise to align with corporate clinical development and commercial goals
- Lead and oversee Pharmacovigilance signal detection and risk management activities for all products in clinical development and implement appropriate risk mitigation strategies to ensure patient safety
- Actively participate and provide strategic planning and Pharmacovigilance input to support product regulatory submissions (IND, NDA, MAA, product labeling)
- Participate in oversight of patient safety in clinical development clinical trials
- Participate and provide strategic planning, assessment and implementation of pharmacovigilance activities to support products in clinical development
- Lead and serve as Pharmacovigilance expert in responding to and resolving safety questions received from or requested by regulatory authorities
- Provide medical safety expertise in reviewing critical documents for clinical development products
- Lead Pharmacovigilance Committee meetings and manage communication of product risk-benefit profile to internal and external stakeholders
- Actively participate and serve as Pharmacovigilance representative in senior leadership committees
- Lead internal safety team and oversee safety vendors to ensure timely delivery of Pharmacovigilance and safety deliverables
- Must actively participate in daily Pharmacovigilance activities with a "can-do, hands-on, positive attitude"
- MD degree with 10+ years of global pharmacovigilance and drug safety and management experience
- Expert knowledge of global safety regulations - FDA, EU GVP, ICH guidelines, and other applicable global safety regulations and guidance
- Expert in clinical safety assessments, signal detection and risk management
- Experience in Pharmacovigilance inspections
- Experience and knowledge in NDA, MAA submissions
- Excellent communication skills (verbal and written)
- Strategic assessment and evaluation skills with strong decision-making abilities
- Ability to navigate fast-paced and dynamic work environment with ability to collaborate with various functions
- Leader with teamwork and collaborative perspective
- GBT values driven leader: Science dedicated to patients; Embrace open communication and debate; Trust, respect, and accountability; One team, one purpose; and always do the right thing
Fit with GBT culture:
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
- Values-based leadership consistent with GBT's Core Values
- Excitement about the vision and mission of GBT
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.