Job Title : Medical Reviewer / Medical Quality Reviewer
Location : Pune | NCR | Kolkata
Working Model : Hybrid
Qualifications :
- MBBS (Medical Degree), preferably with a postgraduate qualification.
- Minimum 2+ years of experience in clinical practice or pharmacovigilance (PV).
- Must hold valid Medical Doctor certification / licensure in the country of service.
- Experience in the pharmaceutical industry preferred.
- Working knowledge of international regulations and guidance documents related to worldwide reporting requirements (US / EU).
Key Responsibilities :
Perform comprehensive medical review of cases, ensuring consistency and accuracy of information.Provide causality assessment and clinical evaluation comments as required.Support the preparation of clinical trial safety assessments , regulatory submissions , and aggregate safety reports .Ensure compliance with pharmacovigilance regulations and company policies.Identify and resolve issues independently; escalate complex matters appropriately.Demonstrate strong analytical and decision-making skills in both routine and complex scenarios.Collaborate effectively within a matrix organization , working both independently and under supervision.Maintain high productivity, organization, and time management to meet regulatory compliance goals.Exhibit excellent oral and written communication in English.Skills & Competencies
Strong understanding of pharmacovigilance processes and safety data management .Proficiency in database management systems and computer applications.Excellent organizational and problem-solving skills.Ability to work under tight timelines while maintaining quality standards.