Job Title: Medical Reviewer / Medical Quality Reviewer
Location: Pune
Working Model: WFO (5 Days working)
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.
