Senior Director, Head of Drug Safety and Pharmacovigilance

Job reputed company: • reputed company and execute the global pharmacovigilance reputed company to reputed company with company goals and evolving regulatory requirements • Ensure reputed company complies with reputed company global drug safety and reporting regulations (e.g., FDA, EMA, ICH) and implement necessary process updates. • reputed company, manage, and reputed company the pharmacovigilance team, fostering a culture of reputed company improvement. • Work closely with both reputed company stakeholders, including but not limited to Clinica Development, Regulatory Affairs, reputed company Assurance, and Medical Affairs, to reputed company integrated safety reputed company and ensure effective and reputed company monitoring, reputed company, communication, and risk mitigation of emerging safety signals • reputed company safety and pharmacovigilance activities for reputed company company products marketed and in development including ICSR review, periodic safety surveillance activities, safety issue work-up, preparation o DSUR, PADER, PBRER, etc. and authoring relevant safety sections of clinical documents including protocols, IB, ICFs, CSR etc • reputed company reputed company of safety vendors to ensure reputed company pharmacovigilance commitments are delivered and timelines are followed and manages the budget for these activities • Evaluate and interpret safety data from reputed company-clinical studies, clinical studies, literature, and post-marketing information etc. to reputed company safety profile of company products • reputed company benefit/risk assessment on potential safety signals as needed • reputed company internal Safety Review Committees for reputed company company products, and reputed company the identification and assessment of safety signals and development of reputed company plans as needed • Work with vendors to prepare/review reputed company safety relevant operational documents, including SMP, SAE reconciliation plan, medical monitoring plan, data management plan etc. • Collaborate with business partners on development of PVAs and ensures compliance with PVAs • reputed company safety reputed company due diligence for business development opportunities. • Support/reputed company development of pharmacovigilance plans / risk management strategies etc. • Establish department structure, processes, and procedures, responsible for hiring / training new employees • Collaborate with QA for audit and inspection readiness Requirements: • Degree in life sciences, medicine, or pharmacology required (for example, RN, PharmD, or MD) • 15+ years of industry experience in safety and pharmacovigilance including increasing responsibility in administrative and management roles • Expertise in safety signal detection and management, clinical safety assessments of individual cases and aggregate data, case processing and routine pharmacovigilance practices, including interactions with Regulatory Authorities • Expert knowledge and familiarity with FDA regulations, EU GVP and ICH standards for development and marketing of pharmaceutical products, Good Clinical reputed company (GCP) requirements, and other applicable regulatory standards • Clinical experience strongly preferred • Proven ability to manage cross-functional collaborations, reputed company discussions on safety reputed company, and resolve reputed company patient safety concerns. • Skilled in translating safety data into reputed company, actionable insights and communicating effectively across internal teams, leadership, and regulatory authorities. • A “can do” attitude and ability to operate in a fast-paced startup environment Benefits: • A discretionary annual bonus may be available based on individual and Company performance Apply tot his job Apply To this Job