Medical Doctor

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.