Pharmacovigilance Physician / Senior Pharmacovigilance Physician
- Perform medical review of non-serious, serious and potentially serious ICSR with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance.
- Support triage of cases and determine seriousness and relatedness across products as assigned.
- Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling, review narrative.
- Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas. Involve in process improvement activities like implementation of quality control process.
- Provide medical guidance and expert opinion on the cases to the data entry associates and peer reviewers to help in resolving queries.
- Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.
- Maintain PV expertise, and understanding of international safety regulations and guidelines.
- Provide strategic and proactive safety input into development plans.
- Support due diligence activities and pharmacovigilance agreements.
- Responsible for completing the MR activities in safety database within the stipulated time.
- Provide feedback to case processors on the errors/ discrepancy noted.
- Ensure timely and appropriate regulatory submissions.
- MBBS / MD with 1-4 years of experience as Medical Reviewer.
- Expert level knowledge and hands-on experience in individual case safety report medical evaluation, coding, documentation, and submission to health authorities.
- Advanced level understanding of international Pharmacovigilance Regulations.
- Excellent written and verbal communication skills in English.