Vice President, Drug Safety & Risk Management - REMOTE
Vice President, Drug Safety & Pharmacovigilance - REMOTE - IMMEDIATE NEED Vice President, Drug Safety & Pharmacovigilance - REMOTE - IMMEDIATE NEED 1 week ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Implaion Recruiting Vice President, Drug Safety & Pharmacovigilance Location REMOTE Seniority Level Executive Employment Type Full-time About the Role We’re looking for a seasoned executive to lead global safety and pharmacovigilance (PV) across all development programs. This role is accountable for patient safety strategy, regulatory compliance, and signal management, from early-stage development through commercialization. You’ll work cross-functionally with Clinical, Regulatory, Medical Affairs, Quality, and external partners.
Key Responsibilities
Own and lead PV strategy across the entire therapeutic portfolio Collaborate cross-functionally to align safety data, risk management, and communication Drive benefit-risk assessments and interface directly with regulatory authorities Lead signal detection using clinical, real-world, and market data Ensure global PV compliance and readiness for inspections/audits Oversee vendor relationships and safety database (e.g., Argus) management Submit DSURs, PSURs/PBRERs, and other safety reports to regulatory bodies Build and lead a high-performing internal safety team What We’re Looking For MD (or equivalent) required 10+ years in pharmacovigilance and drug safety, including biotech leadership Working in a small company environment ( Experience with global safety reporting, outsourced data, and commercial PV systems Expert in MedDRA (SMQs, FMQs, PTs) and signal detection methodologies Familiar with 21 CFR 312.32, 314.80, and BIMO inspection prep Skilled in regulatory engagement, negotiation, and issue resolution Practical, risk-based decision maker with a bias for action Proven leader who can manage internal teams and external vendors with urgency and ownership Seniority level Seniority level Executive Employment type Employment type Full-time Job function Job function Research, Analyst, and Information Technology Industries Executive Search Services Referrals increase your chances of interviewing at Implaion Recruiting by 2x Get notified about new Vice President Clinical Research jobs in United States . Vice President, Clinical Research FSP Consulting Vice President, Clinical Research Endocrinology United States $352,800.00-$442,800.00 9 hours ago United States $330,000.00-$387,000.00 1 week ago Sr. Director, Patient-Centered Research, HEOR United States $222,875.00-$334,313.00 1 week ago Vice President of REQ (Research, Education & Quality) United States $325,000.00-$360,000.00 1 day ago Sr. Director, Patient-Centered Research, HEOR Cambridge, MA $222,875.00-$334,313.00 3 months ago United States $287,500.00-$357,500.00 9 hours ago Medical Director/Senior Director, Clinical Development United States $287,500.00-$357,500.00 9 hours ago Director Clinical Development, Solid Tumors United States $239,600.00-$299,600.00 10 hours ago Executive Director, Global Medical Affairs, Breast Disease Area Lead United States $248,600.00-$328,600.00 1 day ago Executive Medical Director, Clinical Development Oncology Director/Senior Director, Regulatory CMC United States $190,000.00-$260,000.00 1 week ago United States $250,000.00-$300,000.00 1 hour ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Apply To This Job