Alnylam Pharmaceuticals · 12 hours ago
Associate Director, Pharmacovigilance Regulatory Reporting & Submissions
United States
Full-time
Remote
Lead/Staff, Director/Executive
$164K/yr - $222K/yr
10+ years expAlnylam Pharmaceuticals is a leader in RNAi therapeutics, dedicated to transforming lives through innovative science. The Associate Director, Pharmacovigilance Regulatory Reporting & Submissions will oversee the processes for reporting Individual Case Safety Reports (ICSRs) to health authorities and ensure compliance with global regulations while managing vendor relationships and driving process improvements.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
Oversee global ICSR reporting processes to regulatory authorities, Alliance Partners, Data Monitoring Committees(DMCs), Safety Reporting Committees (SRCs) and CROs in compliance with global and regional regulations. This may include oversight of CRO submissions to central IRBs/ECs as organizational responsibilities evolve
Interpret and document ICSR reporting rules in the Alnylam reporting rules tracking repository and serve as Subject Matter Expert for ICSR reporting rules for all Alnylam 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 Quality teams to align safety reporting strategies
Review and/or create metrics to measure reporting compliance to regulatory agencies, Alliance Partners, internal destinations, DMCs, SRCs, and CROs. This may include oversight of vendor performance related to reporting obligations including CRO submissions to central IRBs/ECs 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 timely safety data
Oversee the late ICSR process including investigations, root cause analysis and trending, correction development, and implementation
Qualification
Required
Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field and/or a licensed healthcare professional (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 oversight skills; can establish and maintain effective relationships with customers (internal and external)
Excellent written and verbal communication skills. Able to express complex ideas
Ability to work independently, prioritize effectively and work in a matrix team environment required
Benefits
Comprehensive benefits including medical, dental, and vision coverage
Life and disability insurance
Lifestyle reimbursement program
Flexible spending and health savings accounts
401(k) with a generous company match
Paid time off
Wellness days
Holidays
Two company-wide recharge breaks
Generous family resources and leave
Company
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
1001-5000 employees
H1B Sponsorship
Alnylam Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (18)
2021 (19)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$4.55BKey Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO
Leadership Team
Yvonne Greenstreet
Chief Executive Officer
Jeff Poulton
Chief Financial Officer
Recent News
Clinical Trials Arena
2026-01-16
Longevity.Technology
2026-01-14
2026-01-13
Company data provided by crunchbase