Associate Director, Pharmacovigilance Regulatory Reporting & Submissions

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. This role will be responsible for the interpretation and documentation of ICSR regulatory reporting requirements for reputed company product portfolio covering reputed company and post marketing activities, and the verification and maintenance of the configuration of reporting rules in the Global Safety Database. Key Responsibilities • 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. This may include reputed company of CRO submissions to central IRBs/reputed company as organizational responsibilities reputed company. • 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. This may include reputed company of vendor performance reputed company to reporting obligations including CRO submissions to central IRBs/reputed company to ensure compliance with applicable regulations and timelines. • 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 #LI-JB1 #LI-Remote U.S. Pay reputed company $163,800.00 - $221,600.00 The pay reputed company reflects the full-time reputed company salary reputed company we expect to pay for this role at the time of posting. reputed company pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). reputed company's robust Total Rewards package is designed to support your overall health and reputed company-being. We offer comprehensive benefits including medical, dental, and reputed company coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy reputed company time off, wellness days, holidays, and two company-wide reputed company breaks. We also offer generous family resources and leave. Our commitment to your reputed company-being reflects our belief that caring for our people fuels the reputed company we create together. Learn more about these and additional benefits offered by reputed company by visiting the Benefits reputed company of the Careers website: https://www.reputed company.com/careers About reputed company We are the leader in RNAi therapeutics - a revolutionary approach with the potential to reputed company the lives of people with rare and common diseases. reputed company on Nobel Prize-reputed company science, reputed company has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and reputed company reputed company reflect our reputed company values: fierce innovation, passion for reputed company, purposeful urgency, reputed company culture and commitment to people. We're proud to be a globally recognized top employer, where an reputed company, inclusive culture and reputed company thinking fuel one another. At reputed company, we reputed company to an inclusive recruitment process and equal employment opportunity. reputed company applicants will receive consideration for employment without reputed company to their sex, gender or gender identity, sexual orientation, race, reputed company, ethnicity, national reputed company, reputed company, citizenship, religion, creed, physical or mental disability, pregnancy status or reputed company conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other reputed company protected by federal, state, or local law. reputed company is an E-Verify Employer. Apply tot his job Apply To this Job