Vice President, Drug Safety & Risk Management - REMOTE - IMMEDIATE NEED
Vice President, Drug Safety & Pharmacovigilance - REMOTE - IMMEDIATE NEED Vice President, Drug Safety & Pharmacovigilance - REMOTE - IMMEDIATE NEED 1 week ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Implaion RecruitingVice President, Drug Safety & PharmacovigilanceLocation: REMOTESeniority Level: ExecutiveEmployment Type: Full-timeAbout the RoleWe'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 ResponsibilitiesOwn and lead PV strategy across the entire therapeutic portfolioCollaborate cross-functionally to align safety data, risk management, and communicationDrive benefit-risk assessments and interface directly with regulatory authoritiesLead signal detection using clinical, real-world, and market dataEnsure global PV compliance and readiness for inspections/auditsOversee vendor relationships and safety database (e.g., Argus) managementSubmit DSURs, PSURs/PBRERs, and other safety reports to regulatory bodiesBuild and lead a high-performing internal safety teamWhat We're Looking ForMD (or equivalent) required10+ years in pharmacovigilance and drug safety, including biotech leadershipWorking in a small company environment ( Experience with global safety reporting, outsourced data, and commercial PV systemsExpert in MedDRA (SMQs, FMQs, PTs) and signal detection methodologiesFamiliar with 21 CFR 312.32, 314.80, and BIMO inspection prepSkilled in regulatory engagement, negotiation, and issue resolutionPractical, risk-based decision maker with a bias for actionProven leader who can manage internal teams and external vendors with urgency and ownershipSeniority level Seniority level ExecutiveEmployment type Employment type Full-timeJob function Job function Research, Analyst, and Information TechnologyIndustries Executive Search ServicesReferrals increase your chances of interviewing at Implaion Recruiting by 2xGet 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 agoUnited States $330,000.00-$387,000.00 1 week agoSr. Director, Patient-Centered Research, HEOR United States $222,875.00-$334,313.00 1 week agoVice President of REQ (Research, Education & Quality) United States $325,000.00-$360,000.00 1 day agoSr. Director, Patient-Centered Research, HEOR Cambridge, MA $222,875.00-$334,313.00 3 months agoUnited States $287,500.00-$357,500.00 9 hours agoMedical Director/Senior Director, Clinical Development United States $287,500.00-$357,500.00 9 hours agoDirector Clinical Development, Solid Tumors United States $239,600.00-$299,600.00 10 hours agoExecutive Director, Global Medical Affairs, Breast Disease Area Lead United States $248,600.00-$328,600.00 1 day agoExecutive Medical Director, Clinical Development Oncology Director/Senior Director, Regulatory CMC United States $190,000.00-$260,000.00 1 week agoUnited States $250,000.00-$300,000.00 1 hour agoWe're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.#J-18808-Ljbffr