DUTIES & RESPONSIBILITIES
Manage daily workload in conjugation with line manager for individual case processing, literature searches, aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department.
Medical Review of ICSRs in pharmacovigilance database and aggregate reports for expedited/periodic submission as per the Regulations and SOPs.Signal detection of the ADRs with cases received from clients productsMedical Review of PSUR as per the Regulations and SOPsHandling of medical query/spontaneous ADR cases as per applicable SOP Generation and review of SOPs and WIs and execution of company SOPsMaintain awareness of changes to/new regulations affecting PVG activitiesCompliance to project guidelines Trains and mentors new employees in PVG (if required)To carry out necessary administrative duties required for the jobOther duties as assigned by management Builds and maintains good relationships across functional units and company affiliates
RequirementsREQUISITE EDUCATION LEVEL & EXPERIENCE
A graduate/post-graduate degree in medical science.0-2 yrs. relevant experience;Knowledge of regulatory requirementsGood time management skillsGood presentation skillsAbility to plan & prioritise projects and work effectively
Good communication skills .
