41599-Pharmacovigilance-Medical Review

1 week ago


bangalore, India HyreFox Consultants Full time
Roles and Responsibilities  oReview and verification of appropriate sections of adverse events, appropriate MedDRA coding, labelling, causality and provide a medical assessment comment as needed for ICSR. oReviews medical content and quality of the Case and ensures that all events from the source documents are accurately coded and verify consistency between source documents and narrative summary. oActively follow up of adverse events to obtain more information and review of all letters and queries for appropriateness and completeness. Start an Ad-hoc follow-up whenever required. oConstantly update domain and operations skills as per the changing Regulatory requirements by reading the updated version of SOP. oRoute the Case to Distribution and ensure the case is locked. oProvide feedback for the Case creation and data entry production leads about the quality of data entry in serious cases. oActively involved in case discussion with client and provide the valuable inputs to the team. oOffline peer review of agreed sample of Cases for assessment of quality of narrative, E2B sender’s comment and medical query completeness oTo participate in audits or inspections. oTraining and mentoring of new associates. oAuthoring of process documentsoDrug safety related activities. Desired Profile: - •Adaptable and flexible •Quick learner and a team player •Minimum of medical degree (MBBS). Medical degree with higher speciality preferred. •Min. 2 to 5 years of experience (in ICSR medical review).•In-depth knowledge of medical terminology •Good Communication Skills, medical writing skills and Analytical Ability •Strong English Language proficiency

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