Global Drug Safety Physician
2 weeks ago
Reporting to the Manager, Global Medical Safety, Th Global Drug Safety Physician is responsible for Medical evaluation of individual case safety reports (ICSRs). The person will be responsible for the detection and analysis of safety signals and trends , the preparation of aggregate and periodic safety reports including the benefit-risk evaluation process , will contribute to the preparation and evaluation of risk management. The person will provide medical expertise for health risk assessments . The person will interact with Customers, Health Professionals, Regulatory Agencies, Third party contractors, Commercial partners.
Responsibilities and Duties:
- Ensure medical review and evaluation of individual case safety reports, including decisions on MedDRA coding, seriousness, expectedness and causality assessments
- Provide medical expertise, as well as pharmacovigilance and epidemiological insights to ensure the accurate and timely completion and reporting of aggregate reports, in compliance with internal timeframes and timeframes dictated by regulatory authorities
- Provide medical expertise as well as pharmacovigilance and epidemiological insights to the detection and analysis of safety signals and trends, and the evaluation of the need to update the current official labeling based on safety signals
- Participate in the benefit-risk evaluation process and undertake the preparation and evaluation of risk management plans
- Provide medical expertise and evaluation for Health Risk Assessments, as needed
- Actively contribute to various projects within pharmacovigilance (drug safety related and others as needed) and cross-functionally
- Monitor and notify Health Canada of foreign actions in respect of a serious risk of injury to human health
- Train outside contractors and internal teams on pharmacovigilance and adverse event reporting as well as other pharmacovigilance activities
- Write and update Standard Operating Procedures and Local Working Procedures as needed and assigned
- Provide medical expertise into regulatory responses to various health authorities for specific safety questions
- Support and participate in activities related to Pharmacovigilance audits and inspections
- Work closely with other collaborators, both within the organization and outside
- Support the Manager, Global Medical Safety and the Head of Pharmacovigilance and Medical Information providing medical insights and expertise as needed
Skills, Knowledge and Abilities:
- Bilingual: French and English both spoken and written
- Strong knowledge of the pharmaceutical industry and of the regulatory requirements for ADR and SAE reporting
- Excellent oral and written communication skills
- Ability to work autonomously, to prioritize and handle multiple tasks and to meet tight deadlines
- Team player with excellent leadership and inter-personal skills
- Pro-active, customer-focused, problem-solving, flexible and analytical
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