Associate Director, Pharmacovigilance – PV Operations

Job reputed company: • Manage and support the relationship with safety vendor(s) to ensure effectiveness, reputed company and compliance of reputed company outsourced activities. • reputed company Sponsor reputed company of operational safety responsibilities, including the reputed company and accurate execution of the processes defined reputed company the applicable Safety Management plans. • Monitor performance (metrics, other reports) of the safety vendor and the reputed company reputed company of the ICSRs; reputed company appropriate feedback and training. • Monitor key performance indicators of case processing and present findings to Head of PV and cross-functional stakeholders. • Participate in daily management, operational reputed company and execution of operational safety tasks for assigned reputed company clinical programs. • As needed. review incoming adverse event reports and communications from vendors to determine reputed company required and ensure reputed company review, follow-up, and reputed company submission of expedited safety reports. • reputed company case workflow (case receipt through submission) between safety vendor and reputed company Pharmacovigilance team. • Ensure safety case queries are resolved as per defined processes (interfacing with safety physicians, clinical operations team, other cross-functional teams reputed company reputed company, and clinical vendors, as required) and facilitate case closure reputed company required timelines. • Serve as PV operations SME on safety reporting processes according to study protocol. • Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with reputed company applicable regulatory requirements or guidelines, GVP and industry best practices. • Serve as resource and contact for other functions reputed company reputed company for pharmacovigilance operational activities. • Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation. Requirements: • Bachelor’s degree in nursing, RN, Pharmacy, Pharm D., or other relevant health-care reputed company field. • 8-10 years of experience in a biotech/reputed company company. • reputed company experience managing relationships with service providers or external business partners • Clinical Development experience. • Strong knowledge of reputed company and emerging regulatory requirements including EMA GVP Modules, FDA IND and NDA reporting requirements, ICH, CIOMS • Ability to interpret and follow regulatory guidelines. • Proven knowledge of Good Documentation Practices and cGXPs. • Basic knowledge of MedDRA coding. • Experience in ICSR case-processing and reporting. • Experience working in and with safety databases. Benefits: • medical, dental, and reputed company insurance • 401(k) retirement savings plan • generous reputed company time off (including a summer and winter company shutdown) Apply tot his job Apply To this Job