Job Title: Senior Director of Pharmacovigilance
Location: San Francisco Bay Area, CA
Employer: Meet
Employment Type: Full-Time
Seniority Level: Director
Job Function: Strategy/Planning, Quality Assurance, and Management
Industries: Pharmaceutical Manufacturing and Biotechnology Research
Position Overview:
Meet is recruiting for a Senior Director of Pharmacovigilance (PV) for a clinical-stage biopharmaceutical company focused on rare diseases. The role is based in the San Francisco Bay Area and requires expertise in pharmacovigilance to oversee the safety and regulatory compliance of clinical trials and post-market surveillance.
Key Responsibilities:
Adverse Event (AE) Evaluation: Assess and evaluate adverse event (AE) reports for safety issues, ensuring appropriate actions are taken.
Vendor Management: Oversee and manage PV vendors, ensuring compliance with regulatory requirements and expectations.
Subject Matter Expertise (SME): Act as the SME for Individual Case Safety Report (ICSR) processing, providing guidance and leadership.
Global Compliance: Ensure that AE reporting is in compliance with global regulations (FDA, EMA, ICH).
SOPs and Process Improvement: Update and create Standard Operating Procedures (SOPs), and lead initiatives for process improvements in PV activities.
Cross-Functional Collaboration: Work with internal departments and external partners for efficient drug safety data exchange.
Training & Leadership: Lead training sessions on AE and product complaints for internal teams and external vendors.
Qualifications:
Education: Bachelor’s degree in a science or health-related field; advanced degrees (e.g., Master’s or PhD) are a plus.
Experience: 10+ years in Pharmacovigilance, Drug Safety, or Risk Management.
Knowledge: In-depth understanding of global pharmacovigilance regulations (e.g., US CFR, EMA, ICH).
Technical Skills: Proficiency in safety databases such as Oracle Argus, ArisGlobal.
Communication & Leadership: Strong cross-functional collaboration, leadership, and interpersonal skills.
Ideal Candidate:
Extensive experience in PV, including a deep understanding of global regulations.
Proven leadership skills with the ability to drive improvements and optimize PV processes.
Expertise with safety databases and a strong commitment to regulatory compliance.
Why Apply?
This is an exciting opportunity for a seasoned Senior Director of Pharmacovigilance to contribute to the success of a clinical-stage company focused on rare diseases. The role offers significant leadership opportunities, a collaborative environment, and the chance to drive impactful safety and regulatory initiatives.
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