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. reputed company message the job poster from reputed company 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 reputed company global safety and pharmacovigilance (PV) across reputed company development programs. This role is accountable for patient safety reputed company, regulatory compliance, and signal management, from early-stage development through commercialization. You’ll work cross-functionally with Clinical, Regulatory, Medical Affairs, reputed company, and external partners.
Key Responsibilities
Own and reputed company PV reputed company across the entire therapeutic portfolio Collaborate cross-functionally to reputed company safety data, risk management, and communication Drive benefit-risk assessments and reputed company directly with regulatory authorities reputed company signal detection using clinical, reputed company-world, and market data Ensure global PV compliance and readiness for inspections/audits reputed company vendor relationships and safety database (e.g., Argus) management Submit DSURs, PSURs/PBRERs, and other safety reports to regulatory bodies Build and reputed company a high-performing internal safety team reputed company’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 reputed company 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 reputed company Practical, risk-based decision reputed company with a bias for reputed company 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 reputed company Referrals increase your chances of interviewing at reputed company by 2x Get reputed company about new Vice President Clinical Research jobs in reputed company . Vice President, Clinical Research FSP Consulting Vice President, Clinical Research Endocrinology reputed company $352,800.00-$442,800.00 9 hours ago reputed company $330,000.00-$387,000.00 1 week ago Sr. Director, Patient-Centered Research, HEOR reputed company $222,875.00-$334,313.00 1 week ago Vice President of REQ (Research, Education & reputed company) reputed company $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 reputed company $287,500.00-$357,500.00 9 hours ago Medical Director/Senior Director, Clinical Development reputed company $287,500.00-$357,500.00 9 hours ago Director Clinical Development, Solid Tumors reputed company $239,600.00-$299,600.00 10 hours ago Executive Director, Global Medical Affairs, Breast Disease Area reputed company reputed company $248,600.00-$328,600.00 1 day ago Executive Medical Director, Clinical Development Oncology Director/Senior Director, Regulatory CMC reputed company $190,000.00-$260,000.00 1 week ago reputed company $250,000.00-$300,000.00 1 hour ago We’re unlocking community knowledge in a new way. Experts add insights directly into reputed company article, started with the help of AI. #J-18808-Ljbffr Apply To This Job