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 ICSRs (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 communications 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
- Solid organisation skills
- Punctual
- Database experience

📌 Medical Reviewer (Junagadh)
🏢 ProductLife Group
📍 Junagadh