Medical Reviewer

ProductLife Group; Gurugram District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

ProductLife Group seeks Medical Reviewers with at least 5 years of Pharmacovigilance experience to join our clinical safety team. You will review adverse events, perform causality assessments, and ensure regulatory compliance across projects.

Responsibilities include SUSAR assessments, post-marketing support, and training material development per GCP/GVP standards. MBBS or MD is required, with strong communication and data-management skills.

Qualifications

• MBBS or MD required.
• Minimum 5 years of pharmacovigilance experience.
• Experience with client communications and safety databases is essential.

Responsibilities

• Review adverse events and assess severity; determine actions.
• Draft monthly client reports and present at meetings when required.
• Develop and update training materials in line with GCP and GVP requirements for medical review of all cases.
• Support in audits and inspections and ensure client needs are met.

Skills

Pharmacovigilance

GVP/GCP knowledge

Adverse event assessment

Regulatory compliance

EDC systems

Medical writing

Education

MBBS or MD

Tools

Microsoft Office

EDC systems

Job description

ProductLife Group is looking for Medical Reviewers having minimum 5 years of experience in Pharmacovigilance Medical Reviewing.

Responsibilities

• Clinical Phase: Reviewing adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions (like dose adjustments or trial discontinuation). Make assessments on SUSAR reportability. Perform the review and interpret clinical data, ensure protocol compliance and draft monthly reports for the clients (with presentation at periodic meetings if required). Develop and update current training materials in line with GCP and GVP requirements for medical review of all cases.
• Post‑Marketing (Pharmacovigilance): Support in maintenance of medical platform including SOPs, manual and documents. Interaction with the clients medical team and clinical team. Medical review of the ICSPR (e.g., Spontaneous, literature). Support in causality, medical assessment, benefit-risk evaluation of the medicinal product. Provide feedback and ongoing workshops to develop the medical reviewers. Participate in audits and inspections as required. Ensure understanding of client needs, conventions and ensure expectations are met and exceeded.

Required Education

MBBS, or MD (Doctor of Medicine)

Required Experience

Client communications; Safety Database experience; minimum 5 years experience working for service providers or pharmaceutical company.

Required Technical Skills

• Microsoft package
• Pharmaceutical background; strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
• Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.
• Working knowledge of EDC systems.
• Good Medical knowledge and Pharmacology understanding.

Additional Experience and/or Skills

• Effective communication skills both written and verbal to be able to explain complex concepts and address queries from the team.
• Experience with DSMB preferred.
• Ability to deliver constructive feedback.
• Emotional intelligence.
• Adaptability.
• Analytical skills.
• Flexibility.
• Reliable.
• Strong organization skills.
• Punctual.
• Database experience.