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Exelixis Inc.
Alameda, CA, United States
SUMMARY/JOB PURPOSE: The Vice President, Pharmacovigilance provides strategic leadership, management and oversight of case management, operational processes, the quality management system, compliance operations and monitoring; and safety systems for the Exelixis Drug Safety Department and its partners. In addition, this role oversees the case manag
Job Source: Exelixis Inc.Alector, Inc.
South San Francisco, CA, United States
Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare in
Job Source: Alector, Inc.PSG Global Solutions
San Francisco, CA, United States
Description We're looking for a Drug Safety Associate , working in Biotechnology/Medical Devices industry in 350 DNA Way, South San Francisco, California, 94080, United States . Responsibilities: Establishes work priorities and direction independently with minimal input from Manager. Collects, documents, and processes adverse event (AE) re
Job Source: PSG Global SolutionsRetail Options
South San Francisco, CA, United States
Director, GSPV Operations, Process, Quality, and Compliance Apply Location South San Francisco, CA Full Remote Title: Director, GSPV Operations, Process, Quality, and Compliance Reports to: Vice President, Global Safety and Pharmacovigilance Location: Remote Position Position Overview The Director Global Safety and Pharmacovigilance (GSPV) Opera
Job Source: Retail OptionsEthical Search Professionals, Ltd.
South San Francisco, CA, United States
Director, GSPV Operations, Process, Quality, and Compliance Apply Location South San Francisco, CA Full Remote Type Direct Hire ID BN38-2736227 Title: Director, GSPV Operations, Process, Quality, and Compliance Reports to: Vice President, Global Safety and Pharmacovigilance Location: Remote Position Position Overview The Director Global Safety
Job Source: Ethical Search Professionals, Ltd.Alpha-9 Oncology
San Francisco, CA, United States
“Each of us must work for his own improvement and, at the same time, share a general responsibility for all humanity, our particular duty being to aid those to whom we think we can be most useful.” – Marie Curie We are seeking driven, creative, and entrepreneurial individuals to help shape our company. At Alpha-9, you’ll find a culture of collabora
Job Source: Alpha-9 OncologyBridgeway Professionals
South San Francisco, CA, United States
Director, GSPV Operations, Process, Quality, and Compliance Apply Location South San Francisco, CA Full Remote Title: Director, GSPV Operations, Process, Quality, and Compliance Reports to: Vice President, Global Safety and Pharmacovigilance Location: Remote Position Position Overview The Director Global Safety and Pharmacovigilance (GSPV) Opera
Job Source: Bridgeway ProfessionalsClinical Dynamix, Inc.
South San Francisco, CA, United States
Title: Director, GSPV Operations, Process, Quality, and Compliance Reports to: Vice President, Global Safety and Pharmacovigilance Location: Remote Position Position Overview The Director Global Safety and Pharmacovigilance (GSPV) Operations, Process, Quality and Compliance i s responsible for the establishment, maintenance and oversight of
Job Source: Clinical Dynamix, Inc.Foster City, CA, United States
POSITION SUMMARY
The VP of Drug Safety and Pharmacovigilance will provide the leadership and management for the infrastructure of the Drug Safety and Pharmacovigilance department across both clinical development and commercial products for the company. The optimal candidate participate will lead the department and also collaboratively work across a team of peers in Clinical, Regulatory, Biometrics, Medical Affairs and Commercial and will be accountable for ensuring safety systems, staff and procedures are in place to support a compliant global pharmacovigilance system. The VP of Drug Safety & Pharmacovigilance will interface with vendors, external experts, business partners, investigators, and government agencies.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Oversee the Mirum global PV system to enable compliance with global PV regulatory requirements.
Participate in creation of organizational strategy, goals and objectives for the department and ensure implementation of business plans to support both US and international global safety strategies.
Maintain awareness of new and emerging safety concerns and related communications to the competent authorities in a time frame appropriate to the benefit-risk assessment of Mirum’s products.
Responsible for all medical safety aspects of clinical development and post market surveillance of medicinal products in the Mirum portfolio.
Strategic oversight and overall responsibility of commercial safety reporting requirements for US, EU and other international territories, as required.
Management, oversight and mentorship of staff able to set the strategy for future Drug Safety & PV department build and planning.
Partner with clinical development representatives to lead safety signal assessments and validate safety signals.
Participate in health authority interactions (both written and verbal) and inspections regarding safety risk management; may also oversee team members who support such interactions.
Oversight of Drug Safety Committees & Core Safety Information.
Contribute written summaries and provide safety review for safety components of protocols, IB, clinical study reports, regulatory submissions, label negotiations etc. by working directly with team members and offering tactical support when needed.
Oversee, Write or Review of periodic aggregate/safety reports.
Perform Benefit-Risk Assessments in collaboration with Clinical Development, as required.
Ensure compliance with global safety requirements and inspection readiness, including root-cause analyses.
Manage relationships with clients and team members providing expert safety knowledge.
Qualifications
MD, PharmD or equivalent degree.
Minimum of fifteen (15+) years Pharmacovigilance experience with at least five (5) years of department management experience.
Experience in building teams, directly or matrixed and leading projects.
Experience in risk management strategies and signal detection strategies.
Robust knowledge of global PV requirements.
Experience overseeing safety/PV vendors.
Experience with regulatory authority inspections.
Ability to provide robust safety strategies at the highest level as well as perform detailed work to support Phase 1-3 programs, as well as commercial products.
Strong business acumen and ability to negotiate and collaborate with cross-functional partners to achieve department and company goals.
Effective written, verbal communication and interpersonal, relationship-building skills.
Proven professional track record of strategic, organizational, and executional skills to support project planning across multiple activities, with the ability to anticipate and prioritize team workload on multiple ongoing projects.
Organized, attention to detail, and able to meet timelines in a fast-paced environment.
Able to work with a high level of autonomy and independence.
Knowledge and understanding of regulatory requirements for product approval and compliance in North America and Europe.
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Email Alert for Vice President, Drug Safety & Pharmacovigilance jobs in Foster City, CA, United States
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