Senior Manager, PER LQPPV
Found in: Talent IN C2 - 2 weeks ago
Your Job
Local Person for Pharmacovigilance (LPPV) in India acting as National Contact Person for Pharmacovigilance in INDIA acc. to applicable local regulation. The Local Person for Pharmacovigilance in India is responsible for the establishment and maintenance of the marketing authorization holder’s local pharmacovigilance system, and the performance of local Pharmacovigilance Operations. Close cooperation with the global PV system of the client as well as related global and local departments and functions Issue, review and maintain pharmacovigilance procedures (i.e. Standard Operating Procedures, Working Practices) related to the local tasks in connection with client procedures Close cooperation with the respective Deputy and providing the Deputy with information on relevant current PV activities Deputy is assuming responsibility in case of planned or unplanned absence Decisions regarding handling of safety-relevant issues in close cooperation with the client and global PV Regional Manager Full-fledged LQPPV, with experience in post-marketing and clinical trials. Relevant experience in: Local Literature ScreeningLocal Risk Management PlanAdditional Risk Minimization MeasuresMarket Research and Patient Support ProgramsPV intelligenceSignal detectionPV awareness trainingInspections and auditsGap assessmentDigital and social media monitoringPVAsOther relevant aggregate reportsICSR managementYour Profile
Autonomous, concentrated and high-quality work Ability to work in a team Sense of responsibility Hindi (native speaker) Proficient command of English University degree in Medicine, Pharmacy or Life Science Several years’ experience and profound knowledge in the field of pharmacovigilance Expertise, experience and knowledge regarding relevant global and local legislative and non-legislative guidelines on pharmacovigilance Detailed knowledge of related SOPs (global and local) Participation in all relevant courses of instruction such as internal trainings and applicable external courses Experience in all operative tasks that are performed by the members of the pharmacovigilance department Familiarity with industry principles of pharmacovigilance Ability to organise operational procedures and mange different tasks at the same time (e.g. effective coordination of personnel resources for time-conflicting projects) Ability to adjust rapidly to new, unknown, challenging situations Ability to analyze and solve problems and to develop possible solutionsWe offer
A collaborative and diverse work environment that values innovation and inclusivity. Opportunity to join a fast paced growing Global MNC and conquer exciting and varied challenges alongside a talented team Ability to work independently and collaborate effectively in a global, cross-cultural environment. Flexible working hours striking a good work life balance Business interaction with nearly all branches of the company across 5 continents A broad range of initiatives for personal development and professional training-
Senior Manager, PER LQPPV
Found in: Whatjobs IN C2 - 2 weeks ago
noida, India PharmaLex Full timeYour Job Local Person for Pharmacovigilance (LPPV) in India acting as National Contact Person for Pharmacovigilance in INDIA acc. to applicable local regulation. The Local Person for Pharmacovigilance in India is responsible for the establishment and maintenance of the marketing authorization holder’s local pharmacovigilance system, and the...
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Found in: Talent IN C2 - 2 weeks ago
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