@ MacroGenics
  • Post Date : Jan 10, 2022
  • Apply Before : Mar 22, 2022
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Job Description

Summary of Position

The Pharmacovigilance (PV) Physician is responsible for monitoring and managing the safety profile of both investigational and marketed products at MacroGenics. This includes timely review, analysis, and synthesis of drug safety data, identification and investigation of potential safety signals, and establishment of benefit-risk profiles and prevention/mitigation strategies. This individual serves as medical safety advisor to research and development teams throughout the product life cycle, escalating safety concerns within the organization according to established safety governance policies and keeping senior leadership informed of safety issues. This individual performs the above duties with minimal direction or supervision.

Responsibilities and Job Duties

  • Conducts safety surveillance over product life cycle, reviewing clinical trial and post-marketing Individual Case Safety Reports (ICSRs), including Adverse Event Reports (AEs), Serious Adverse Event Reports (SAEs), and Product Complaints (PCs). Identifies emerging safety issues and responds accordingly.
  • Analyzes aggregate safety data from clinical trial reports and from spontaneous post-marketing sources (providers, patients, caregivers, medical literature, industry partners, and vendors/contractors). Identifies concerns and communicates and manages emerging signals and safety data to internal and external stakeholders.
  • Collaborates with Safety Specialists to manage analysis of clinical and post-marketing safety data, provides medical assessment, and instructs staff on appropriate query and follow-up activities
  • Collaborates with Clinical Development and Clinical Operations teams on safety of clinical studies to ensure accuracy, completeness, and quality of Clinical Trial ICSRs Ensures medical integrity of cases
  • Leads and/or contributes to medical safety of clinical trials, including monitoring of clinical trial safety and laboratory data
  • Evaluates safety data and contributes/authors safety statements as a medical safety subject matter expert (SME) on behalf of PVRM for:
    • Study Protocols
    • Clinical Study Reports (CSR)
    • Investigator’s Brochures (IB)
    • Investigator communications (Dear Health Care Provider letters – DHCP)
    • Aggregate Reports (PADER, PSUR, PBRER, DSUR, IND/NDA Annual Reports)
    • Company Core Data Sheets (CCDS)
    • Locally approved labels such as, United States Prescribing Information (USPI), European Summary of Product Characteristics (SmPC), and Canadian Product Monograph (PM)
  • Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, adverse event coding, concomitant medication coding, and causality statements. Raises concerns and safety issues to manager and strategizes resolutions.
  • Contributes to Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategy (REMS)
  • Fields safety questions from Institutional Review Board (IRB)/Ethics Committee and Investigators and prepares and provides appropriate responses.
  • Performs aggregate review of post-marketing safety data in support of safety signal validation, trend detection, risk benefit management, and development of risk mitigation strategies.
  • Performs responsibilities based on knowledge of applicable local/global regulatory regulations and guidance.
  • Responsible for the recruitment and selection, training, individual and career development and coaching, mentoring and overall leadership of team members.
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