Remote Associate Medical Safety Director, Global Medical Review

Alnylam Pharmaceuticals; Cambridge (MA); Remote; USD 193,000 - 261,000; Full time

Benefits offered by this job

Remote work

Job summary

Alnylam Pharmaceuticals in the United States is seeking an Associate Medical Safety Director to oversee daily medical review and causality assessment of ICSRs, including device safety considerations. You will contribute to safety surveillance plans and collaborate with Clinical Development, Data Management, and Pharmacovigilance teams.

Ideal candidates have MD training with pharma pharmacovigilance experience, strong analytical skills, and the ability to navigate regulatory guidelines across

Qualifications

• MD degree with at least 1 year of clinical medical practice.
• Minimum of 3 years of pharmaceutical industry experience in a medical review or related pharmacovigilance role.
• Strong clinical acumen with broad knowledge across multiple therapeutic areas.
• Demonstrated ability to synthesize, critically evaluate, and interpret safety data from multiple sources.
• Excellent written and verbal communication skills with cross-functional stakeholders.
• Strong understanding of FDA, EU, and ICH guidelines and regulatory reporting requirements.
• Knowledge of medical device safety review is preferred.
• Ability to work in a fast-paced, collaborative environment with multiple priorities.

Responsibilities

• Perform daily medical review and causality assessment of ICSRs to support signal detection and management.
• Support medical device safety assessments and MDR-related case evaluation.
• Collaborate with pharmacovigilance colleagues to harmonize safety issue assessment and communication.
• Identify topics for escalation and work with Safety Product Leads on investigations.
• Review safety data and aggregate datasets to identify emerging trends and signals.
• Provide medical input into data review plans, surveillance activities, and monitoring strategies.
• Coordinate with SRM Quality and Case Management to address review issues.
• Participate in process improvements for the Medical Review team.
• Maintain close communication with case processing and medical review vendors.

Skills

MD degree

Clinical experience

Pharmacovigilance knowledge

Analytical thinking

Communication skills

Education

MD degree

Job description

Alnylam Pharmaceuticals in the United States is seeking an Associate Medical Safety Director to oversee daily medical review and causality assessment of ICSRs, including device safety considerations. You will contribute to safety surveillance plans and collaborate with Clinical Development, Data Management, and Pharmacovigilance teams.

Ideal candidates have MD training with pharma pharmacovigilance experience, strong analytical skills, and the ability to navigate regulatory guidelines across