West Conshohocken, PADescription:
Our client is currently seeking a Safety Physician, Global Pharmacovigilance
Location: Conshohocken, PA (Hybrid)
Type: Direct Hire
- Conduct medical review of individual case safety reports (ICSRs) including identification of appropriate follow-up requests of important medical information for the proper medical assessment and evaluation of cases.
- Ensures ICSRs are medically accurate, complete, coded appropriately (MedDRA), with appropriate causality assessment, seriousness and expectedness.
- Ensures accuracy and timeliness of expedited reports and periodic reports from postmarketing surveillance and clinical trials.
- Participates in the identification, analysis and reporting of possible trends and concerns with company products including the identification and evaluation of safety signals through assessment of single case safety reports, aggregate trend analyses, and literature review.
- Participate in the preparation and maintenance of Reference Safety Information (RSI) and product labeling (e.g. Company Core Safety Information (CCSI), Investigator Brochure (1B), national labels).
- Actively participate in a multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations related to safety issues.
- Collaborate with key stakeholders including business partners in appropriate safety analyses and risk assessment and management strategies.
- Author medical-safety sections of aggregate safety reports (DSUR, PBRER).
- Participate in development of safety-related responses to queries from Regulatory Authorities.
- Participate in development of internal PV business infrastructure including standard operating procedures and work practice instructions to ensure seamless PV processes.
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- Clinical Trials
- Detection Theories
- Infrastructure Management
- Multidisciplinary Approach
- Remote Monitoring