Medical Reviewer Job at Unichem Laboratories | MBBS, MD & MS Professionals Apply Now!
Unichem Laboratories Limited is one of India’s established pharmaceutical companies, committed to developing, manufacturing, and delivering high-quality healthcare products. Headquartered in Mumbai, the company focuses on innovation, research, and patient-centric healthcare solutions across diverse therapeutic areas.
About the role
Unichem Laboratories Limited is hiring an experienced Medical Reviewer for its Mumbai office. The role is suitable for professionals with 5–10 years of experience in pharmacovigilance and medical review. The selected candidate will perform medical review of adverse event reports, causality assessments, signal management, and aggregate report evaluation while ensuring compliance with international regulatory guidelines.
Responsibilities
- Perform triage of adverse event reports in the Argus Database.
- Conduct medical review of adverse event reports.
- Perform causality assessments for individual case safety reports.
- Support signal detection and signal management activities.
- Review aggregate safety reports.
- Evaluate and update SmPC and PIL documents as required.
- Ensure compliance with FDA, ICH GCP, GVP Modules, and other regulatory guidelines.
- Maintain high-quality pharmacovigilance documentation.
- Collaborate with internal stakeholders to support drug safety activities.
Requirements
- MBBS in any specialisation or MD/MS in any specialisation.
- 5–10 years of relevant experience in pharmacovigilance, drug safety, or medical review.
Skills
- Expert knowledge of international guidelines and country-specific regulatory requirements (FDA, ICH GCP, GVP Modules; respective EU Clinical Trial Directive, etc.).
- Experience with ICSR review and assessment.
- Strong interpersonal skills and the ability to be flexible in varying environments.
- Good attention to detail and decision-making skills.
Location: Mumbai, Maharashtra, India