1-617-500-6690 [email protected]

Company:  Confidential

Job Title: Associate Director Pharmacogivilance Physician

Job Number: 29888

Location: Raleigh, NC

Job Description

As the medical and pharmacovigilance expert, responsible for management of benefit-
risk profile including review and analysis of safety data from post-marketing sources and
from clinical trials, the identification and investigation of safety signals etc.

Responsibilities

  • Oversight of medical review of ICSRs from both clinical trials and post-marketing to ensure medical accuracy and completeness of case reports, including event coding, seriousness, causality, expectedness and company comment.
  • Lead and/or participate in the identification and assessment of potential safety signals for products and communication to the relevant safety governance body.
  • Lead the medical safety strategy and/ or draft safety sections for aggregate reports (e.g., DSUR, PBRER/PSUR, PADER), regulatory requests, and signal assessments, as needed.
  • Ensures accuracy and timeliness of expedited reports and periodic reports from post marketing surveillance and clinical
  • Lead and/or participate in development and maintenance of risk management plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS), as needed.
  • Provide medical safety input for Investigator’s Brochures (IBs), protocols, Case Report Forms (CRFs), Clinical Study Reports (CSRs), Packaging Inserts and other regulatory documents and communications.
  • Collaborate with Business Partners on the exchange of safety data, safety monitoring and safety profiles, as agreed in Pharmacovigilance Agreements.
  • Provide consultation for pharmacovigilance related questions from cross-functional   teams , vendors, external partners
  • Closely collaborate with PV Operation, Clinical Operation, Regulatory Affairs, cross-functional teams and applicable vendors for seamless PV process.
  • Contribute expertise in medical safety to the development and maintenance of Pharmacovigilance systems and processes
  • Provide support during inspections by Health Authorities, including preparation of medical safety documentation, and follow-up activities such as responses to Regulatory Authority, CAPA development and implementation Demonstrate knowledge and ensure compliance with applicable global PV regulations and guidelines (e.g. CIOMS, FDA, EMA, ICH, )

Required Skills

  • Medical degree required or internationally recognized equivalent
  • Minimum of 5 years of experience in pharmacovigilance, ideally within both post market and clinical safety
  • Sound knowledge of pharmacovigilance practices, particularly in relation to signal detection and evaluation and risk management, and of the regulatory requirements relating to pharmacovigilance in the US and internationally .
  • Excellent analytical, problem-solving, strategic planning, and interpersonal skills
  • Organized, able to multi-task effectively
  • Collaborative, team-oriented, flexible
  • Fluency in English (written and verbal communication skills)

 

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