Pharmacovigilance Medical Assessor (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 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 - Strong organisation skills - Punctual - Database experience .