Medical Reviewer Job at Unichem Laboratories Limited
The Unichem Medical Reviewer Job opportunity is open at Unichem Laboratories Limited for the position of Medical Reviewer – Pharmacovigilance. Candidates with an MBBS or MD/MS qualification and 5–10 years of professional experience can explore this opportunity in drug safety and pharmacovigilance. The role involves medical review of adverse event reports, causality assessment, signal management, aggregate report review, and evaluation of product information documents. Applicants with experience in Individual Case Safety Reports (ICSRs) and knowledge of international pharmacovigilance regulations may find this position relevant to their career goals.
About the Company:
Promoted by the late Mr. Amrut Mody, a pioneer of the Indian pharmaceuticals business, Unichem Laboratories has grown to become one of India’s most respected pharmaceutical companies. It is committed to deliver better health through superior products. By combining strategic research and in-depth industry knowledge, Unichem aims to transform itself into a global pharmaceutical drug Company with an increasing focus on cutting-edge research and developed markets. With formulations constituting the core of the company’s business, Unichem is backward integrated to API Manufacturing, which adds value to the customer in terms of quality and sustainability. Inspired by an ambition to drive path-breaking innovative research, Unichem aims to enhance people’s health by consistently providing better, more effective and safer products.
Job Details:
- Company: Unichem Laboratories Limited
- Position: Medical Reviewer – Pharmacovigilance
Eligibility Criteria:
- Experience: 5 to 10 Years
- Qualification: M.B.B.S. in Any Specialization / Medical-MS/MD in Any Specialization
Key Responsibilities for Unichem Medical Reviewer Job:
- Triage of adverse event reports in Argus Database
- Medical review of adverse event reports in Argus Database
- Causality assessment of adverse event reports in Argus Database
- Signal management activities
- Medical review of aggregate reports
- SmPC and PIL evaluation, comparison, and updates as required
Required 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.