Medical Safety Physician, Pharmacovigilance

The Medical Safety Physician will be responsible for the medical safety activities of all pharmacovigilance activities for the assigned products including medical review of all ICSR, aggregate reports related activities and support signal detection, risk management, and submission associated activities.

Responsibilities:

• Lead safety surveillance and signal management activities for assigned products.

• Provide medical expertise to support signal detection, signal validation, risk assessment, and risk management activities.
• 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.
• 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.

• 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 input into case assessments, narrative development, query resolution, and evaluation of similar or related adverse event cases.
• Review and provide guidance on adverse event coding (MedDRA) and drug coding (WHO Drug) for clinical trial and post-marketing safety data.

• 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 development, maintenance, and periodic updates of Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and other risk management documentation.
• 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.
• Serve as a medical safety resource for clinical development programs by providing safety input into clinical trial protocols, informed consent forms (ICFs), investigator brochures (IBs), and Reference Safety Information (RSI).
• Contribute to the preparation, review, and medical oversight of safety-related content for regulatory and clinical development documents, including:

• Clinical trial protocols and amendments
• Informed consent/assent forms
• Case report forms (CRFs)
• Statistical analysis plans
• Clinical study reports and synopses
• Integrated summaries of safety
• New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and Common Technical Document (CTD) submissions
• Regulatory authority responses and briefing documents
• IRB/EC submissions
• Scientific publications, manuscripts, and other safety-related communications

Qualifications:

• Medical degree (MD or equivalent at minimum). Prior experience in oncology NDA/BLA submissions is highly preferred.
• 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.
• Experience with Argus safety databases, EDC systems, and electronic document management systems is highly preferred.
• Knowledge of GCPs, GVPs, FDA, EMA, ICH guidelines, and international regulations.
• 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.