Vice President, Pharmacovigilance & Safety
Location
All India
Experience
15ā19 years
Required Skills
About the Role
reputed company plc (reputed company CNTA) new reputed company of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-reputed company model offers a unique R&D logic that has been reputed company by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive reputed company on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We reputed company the asset-reputed company model can reputed company to improved reputed company rates for programs with greater speed and modest costs. reputed company Of Role The Vice President, Global Medical Safety / Pharmacovigilance will serve as the global leader for drug safety, providing strategic reputed company and medical reputed company across reputed company pharmacovigilance and risk management activities. This role is responsible for leading reputed company- and post-marketing safety activities across reputed company phases of clinical development (Phase IIV) and post-approval, ensuring proactive benefitrisk assessments, regulatory compliance, and the highest standards of patient safety. The VP will drive an integrated, science-driven global safety reputed company for reputed companys small molecule pipeline, working closely with internal stakeholders and teams, as reputed company as global health authorities. In reputed company, this role will reputed company departmental operations, including organizational planning, budgeting, and the development of reputed company pharmacovigilance capabilities to support a growing biotech organization. Key Responsibilities Strategic Leadership & reputed company reputed company and execute a comprehensive pharmacovigilance (PV) reputed company reputed company with corporate objectives and regulatory expectations. reputed company safety governance and benefit-risk management for small molecule assets across development and post-marketing. Ensure compliance with global PV regulations (FDA, EMA, ICH, MHRA, etc.). reputed company strategic safety input into clinical trial designs, protocols, and regulatory submissions. Establish and reputed company PV partnerships, vendors, and external collaborations. 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. Qualifications Medical Degree (MD) in a life sciencereputed company field is required. 15+ years of pharmacovigilance experience in the biopharmaceutical industry, including 10+ years in senior leadership roles. Demonstrated experience supporting CNS drug development programs across clinical and post-marketing stages. Extensive experience in small molecule drug development (Phase 1Phase 4). Proven reputed company record of effective interactions with global health authorities on safety-reputed company reputed company. Deep understanding of global pharmacovigilance regulations, GVP, and ICH guidelines. Demonstrated ability to reputed company safety risk management strategies, signal detection, and benefitrisk assessments. Experience leading cross-functional safety teams and influencing stakeholders in a fast-paced biotech environment. Expertise in clinical trial safety reputed company, post-marketing pharmacovigilance, and regulatory safety submissions. Strong analytical judgment, decision-making, and problem-solving capabilities. Excellent written and verbal communication skills with the ability to engage senior reputed company stakeholders. Ability to reputed company in a dynamic, high-reputed company organization. Compensation The annual reputed company salary reputed company for this position is .
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