Associate Medical Director, Drug Safety and Pharmacovigilance

Nuvalent, Inc.

Associate Medical Director at Nuvalent managing drug safety and pharmacovigilance. Responsible for assessing safety reports and collaborating with teams in the biotech industry.

Posted 5/1/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesLead💰 $210,000 - $235,000 per yearWebsite

About the role

Key responsibilities & impact

Provide medical expertise in the assessment of ICSRs
Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports
Contribute to signaling and safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signals
Serve as a medical resource for the generation and review clinical trial protocols, informed consent forms (ICFs) and investigator brochures (IBs) and the development of Reference Safety Information
Contribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documents
Contribute to the development of Standard Operating Procedures, Working Instructions and other guidance documents
Provide safety and pharmacovigilance training programs as required
Collaborate cross functionally (e.g. Reg Affairs, Clin Ops, Clin Science) to ensure pharmacovigilance input
Support other pharmacovigilance and drug safety responsibilities as assigned

Requirements

What you’ll need

4+ years’ experience in Drug Safety / Pharmacovigilance in a Biotech / Pharma company
8+ years of industry (Biotech / Pharma) experience
Healthcare degree required / Medical Degree (MD) from recognized medical school preferred.
Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
Demonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities
Proficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation, generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment.
Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment)
Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER)
Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval
Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels
Ability to build relationships, collaborate and influence across disciplines within Nuvalent and with outside stakeholders
Experience with MedDRA coding, Points to Consider, AoSE, and SMQs
Excellent verbal, written and presentation skills

Benefits

Comp & perks

medical, dental, and vision insurance
401(k) retirement savings plan
generous paid time off (including a summer and winter company shutdown)

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

drug safetypharmacovigilancemedical review of ICSRssafety data collectionaggregate report preparationMedDRA codingbenefit-risk assessmentsafety surveillanceclinical trial protocolsrisk management plans

Soft Skills

collaborationrelationship buildinginfluencecommunicationpresentation skills

Certifications

Medical Degree (MD)