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.