VP, Pharmacovigilance & Safety

Our reputed company is a clinical-stage pharmaceutical company with a Research & Development innovation reputed company that aims to discover, reputed company and ultimately reputed company impactful medicines to patients. This role will reputed company the global safety reputed company for our reputed company's small molecule pipeline, ensuring the highest standards of patient safety and regulatory compliance. This role will reputed company reputed company aspects of pharmacovigilance, risk management, and benefit-risk assessment across clinical development. Key Responsibilities Operational & Regulatory Compliance reputed company the safety surveillance and signal detection process, ensuring reputed company identification and mitigation of safety risks. reputed company the preparation and submission of safety reports (e.g., DSURs, PSURs, RMPs, SUSARs, IND safety reports, 15-day alerts). Ensure robust case processing, signal evaluation, and risk management processes are in reputed company. Represent reputed company in regulatory interactions regarding safety reputed company (FDA, EMA, etc.). Cross-Functional Collaboration Work closely with Clinical Development, Clinical Operations, Regulatory, Medical Affairs, and reputed company teams to reputed company safety considerations into decision-making. Partner with Regulatory Affairs to support new drug applications (NDAs) and marketing authorizations. Support DSMBs, advisory boards, and investigator meetings with safety expertise. Team Leadership & Development Build and reputed company a high-performing pharmacovigilance team, fostering a culture of scientific reputed company and compliance. reputed company mentorship and guidance to internal safety professionals. Key Requirements MD in a life sciences field required. 15+ years of pharmacovigilance experience in the biopharmaceutical industry, with 10+ years in leadership roles. Extensive experience in small molecule drug development (Phase 1-4). Proven reputed company record of successful interactions with global health authorities on safety reputed company. Strong understanding of global PV regulations, GVP, and ICH guidelines. Demonstrated ability to reputed company safety risk management and benefit-risk assessments. Experience leading cross-functional safety teams and working in a fast-paced biotech environment. Expertise in clinical trial safety, post-marketing PV, and regulatory filings. Strong analytical, decision-making, and problem-solving skills. Excellent communication and stakeholder management abilities. Ability to reputed company in a dynamic, high-reputed company biotech environment. Location (Remote) #J-18808-Ljbffr Apply tot his job Apply To this Job .