Associate Director, Pharmacovigilance Regulatory Reporting & Submissions

<

Overview

The Associate Director, Pharmacovigilance Regulatory Reporting & Submissions is responsible for the oversight of the processes and systems which enable reporting of Individual Case Safety Reports (ICSRs) to health authorities, Alliance 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 the company product portfolio covering pre and post marketing activities, and the verification and maintenance of the configuration of reporting rules in the Global Safety Database.

Key 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

Qualifications

• 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

#LI-JB1 #LI-Remote

U.S. Pay Range

$ - $

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base 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).

Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision 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 paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave.

Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website:

About Alnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning…