Pharmacovigilance Services Specialist

Job Description

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS/MD Years of Experience: 3 to 5 years Language - Ability: English(International) - Proficient About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? Performs Medical Assessment activities related to drug safety Pharmacovigilance for the Individual Case Safety Reports - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals - Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP - Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables - Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable - Performs labelling of events of applicable cases - Provides Medical Expertise to case processing team whenever required - Provides training/mentoring to the team members wherever applicable Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Understanding of Pharmacovigialnce Experience in Medical Review of ICSRs Medical Review Roles and Responsibilities: - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals - Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP - Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables - Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable - Performs labelling of events of applicable cases - Provides Medical Expertise to case processing team whenever required - Provides training/mentoring to the team members wherever applicable Show more Show less