Medical Reviewer

ProductLife Group · India

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
• Strong organisation skills
• Punctual
• Database experience