Medical Reviewer Hyderabad (India)

ProductLife Group; India; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

ProductLife Group is seeking a Medical Reviewer with 5+ years in pharmacovigilance to assess AEs, determine actions, and ensure regulatory compliance. You will support SUSAR analyses, draft client reports, and help update training materials per GCP/GVP standards.

Collaboration with client medical teams and audits are part of the role. The position emphasizes strong communication, analytical skills, and a solid pharmacovigilance knowledge base to deliver accurate safety assessments and proactive

Qualifications

• MBBS or MD required and relevant pharmacovigilance experience.
• Minimum 5 years in pharmacovigilance medical reviewing.
• Demonstrated client communications and service-provider experience.

Responsibilities

• Review AEs, assess severity and decide actions.
• Assess SUSAR reportability and regulatory implications.
• Draft monthly client reports and present findings.
• Develop and update training materials per GCP/GVP.
• Support SOPs, manuals and documents for pharmacovigilance.
• Interact with client medical teams and clinical teams.
• Participate in audits and inspections as required.

Skills

Pharmacovigilance

Adverse event reporting

SUSAR assessments

Medical review

Causality assessment

FDA/GCP/GVP knowledge

Communication skills

Analytical skills

DSMB experience

Regulatory compliance

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 IC (e.g., Spontaneous, literature)
• Support in causality, medical assessment, advantage-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 solid 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 .