Job Title: Associate Director Pharmacogivilance Physician
Job Number: 29888
Location: Raleigh, NC
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.
- 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, )
- 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)