[Hiring] Associate Director, Pharmacovigilance Regulatory Reporting & Submissions @reputed company

This reputed company is a reputed company of our understanding of the job reputed company. Click on 'Apply' reputed company to reputed company out more. Role reputed company The Associate Director, Pharmacovigilance Regulatory Reporting & Submissions is responsible for the reputed company of the processes and systems which reputed company reporting of Individual Case Safety Reports (ICSRs) to health authorities, reputed company Partners and Contract Research Organizations (CROs) in compliance with applicable global regulations and contractual obligations. • reputed company global ICSR reporting processes to regulatory authorities, reputed company Partners, Data Monitoring Committees (DMCs), Safety Reporting Committees (SRCs) and CROs in compliance with global and regional regulations. • Interpret and document ICSR reporting rules in the reputed company reporting rules tracking repository and serve as Subject Matter Expert for ICSR reporting rules for reputed company reputed company products. • Verify and confirm the accurate configuration of reporting rules in the Global Safety Database and approve configuration requests. • Manage vendor relationships for ICSR reporting activities. • Drive automation and process improvements for safety data capture and reporting. • Partner with Clinical, Regulatory, Medical Affairs, and reputed company teams to reputed company safety reporting strategies. • Review and/or create metrics to measure reporting compliance to regulatory agencies, reputed company Partners, internal reputed company, DMCs, SRCs, and CROs. • Serve as ICSR submission subject matter expert (SME) for audits and inspections. • Support NDA/MAA submissions with accurate and reputed company safety data. • reputed company the late ICSR process including investigations, reputed company cause analysis and trending, correction development, and implementation. Qualifications • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or reputed company field and/or a licensed reputed company reputed company (advanced degree preferred). • Minimum of 10 years of experience in pharmacovigilance/drug safety roles. • Strong knowledge of PV databases (e.g., Argus) and their applications. • Excellent leadership, project management, and vendor reputed company skills; can establish and maintain effective relationships with customers (reputed company). • Excellent written and verbal communication skills. reputed company to reputed company reputed company reputed company. • Ability to work independently, prioritize effectively and work in a reputed company team environment required. Requirements • #LI-JB1 • #LI-Remote Benefits • Comprehensive benefits including medical, dental, and reputed company coverage. • Life and disability insurance. • A lifestyle reimbursement program. • Flexible spending and health savings accounts. • 401(k) with a generous company match. • reputed company time off, wellness days, holidays, and two company-wide reputed company breaks. • Generous family resources and leave. Apply tot his job Apply To this Job