We are looking for an experienced Medical Reviewer to perform medical assessment and review of Individual Case Safety Reports (ICSRs), ensuring medical accuracy, regulatory compliance, and adherence to client-specific PV requirements.
Key Responsibilities
- Perform medical review of ICSRs received from various sources.
- Assess seriousness, causality, expectedness/listedness, and medical significance of adverse events.
- Review and validate medical narratives for accuracy, consistency, and completeness.
- Evaluate patient history, laboratory data, concomitant medications, and clinical information.
- Review MedDRA coding and ensure appropriate medical terminology.
- Identify missing or inconsistent medical information and recommend follow-up queries.
- Review complex and medically significant cases.
- Ensure compliance with PV SOPs, regulatory requirements, and client-specific procedures.
- Participate in quality review, case discussions, and medical calibration meetings.
- Provide medical guidance to case processors and PV teams.
- Support identification and escalation of potential safety signals where applicable.
- Maintain high standards of medical quality and case-processing timelines.
Required Skills
- Strong clinical and medical assessment skills.
- Good knowledge of Pharmacovigilance and ICSR processing.
- Understanding of seriousness, causality, expectedness, and listedness.
- Knowledge of MedDRA terminology and coding.
- Ability to interpret clinical information, medical history, laboratory results, and treatment information.
- Strong attention to detail and analytical skills.
- Positive written and verbal communication skills.
- Ability to handle complex medical cases independently.
Educational Qualification
- MBBS / MD / Medical Degree preferred.
- Candidates with relevant clinical experience and Pharmacovigilance exposure may be considered depending on the requirement.
Experience
- 3-8 years of relevant experience in Medical Review/Pharmacovigilance/Clinical Research.
- Hands-on experience in ICSR medical review is highly preferred.
- Experience with global PV regulations and safety databases is an advantage.