Verastem

Medical Safety Physician, Pharmacovigilance

Boston, Massachusetts

Sponsorship not specified$230k-$317kDetected 29 days ago

StatisticsClinical TrialsFDA RegulatoryPharmacovigilanceCommunication

About the role

Ensure timely evaluation, escalation, and communication of confirmed safety signals and associated benefit-risk implications.
Provide medical oversight and expert clinical assessment of Individual Case Safety Reports (ICSRs) for investigational and marketed products.
Provide medical input into case assessments, narrative development, query resolution, and evaluation of similar or related adverse event cases.

Lead safety surveillance and signal management activities for assigned products.
Direct or support safety scientists in signal detection, evaluation, and safety surveillance processes, including identification and assessment of safety observations, emerging safety concerns, and potential safety signals.
Support the development and continuous improvement of pharmacovigilance processes through the creation and revision of Standard Operating Procedures (SOPs), work instructions, and related guidance documents.
New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and Common Technical Document (CTD) submissions
Regulatory authority responses and briefing documents

Knowledge of GCPs, GVPs, FDA, EMA, ICH guidelines, and international regulations.
Medical degree (MD or equivalent at minimum).
Minimum 8 years of experience as pharmacovigilance physician with strong experience in handling ICSR processing for clinical trials and marketed drugs, signal detection, aggregate reports development and safety analyses from clinical trials.
Authorized to legally work in USA and will not require support anytime.
The base salary range ($230,000 - $317,000) provided reflects our current estimate of what we anticipate paying for this position.
Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics.
In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.

Prior experience in oncology NDA/BLA submissions is highly preferred.
Experience with Argus safety databases, EDC systems, and electronic document management systems is highly preferred.

Conduct medical review of ICSRs and support aggregate safety reporting activities, including PSURs, PBRERs, DSURs, Annual Safety Reports (ASRs), and other regulatory safety submissions.

Provide medical expertise to support signal detection, signal validation, risk assessment, and risk management activities.
Review product quality complaints and perform medical impact assessments and health hazard evaluations, as appropriate.
Conduct critical review and interpretation of scientific literature and other relevant data sources to support signal detection, signal evaluation, benefit-risk assessment, and other pharmacovigilance activities.
Contribute to the preparation, review, and medical oversight of safety-related content for regulatory and clinical development documents, including:

This listing is sourced directly from Verastem's careers page and normalized into a canonical job model.