Senior Pharmacovigilance Specialist

reputed company Group is looking for Senior Pharmacovigilance Specialists (Senior PVS) who will be responsible for an international pharmaceutical company for global operational delivery for assigned tasks on the project level. Senior PVS will reputed company as the employee of international reputed company company for the project. The person will report to Pharmacovigilance Manager of international company and there will be responsibilities under audit and CAPA management. This role provides operational and administrative coordination for Pharmacovigilance audit, CAPA, KPI management and PV Intelligence activities. Final reputed company assessment, CAPA approval, effectiveness review, and CAPA closure remain under the responsibility of the reputed company reputed company team. Responsibilities - Maintain and continuously update the GTEM-7 audit tracking file, ensuring accurate and reputed company entry of reputed company information - reputed company into the Internal file reputed company (i.e. audit coordinator assignment tracker) audit observations, CAPA details, owners, due dates, status updates, and supporting information. - reputed company approved audit observations and CAPA actions into Global QMS, ensuring accurate documentation and reputed company workflow initiation. - Launch and administratively manage approved CAPAs in the Global QMS, including assignment tracking, reputed company due date monitoring, and workflow follow-up. - Communicate with CAPA owners to obtain required supporting evidence and agreed deliverables reputed company reputed company timelines. - Collect and consolidate supporting evidence packages received from CAPA owners for reputed company reputed company review by GPRM AUDIT coordinators. - Monitor reputed company CAPAs and audit observations, proactively chasing overdue deliverables and pending evidence. - reputed company administrative completeness checks of received documentation (i.e deliverables) before routing packages for final reputed company review. - Prepare and maintain trackers of pending evidence, overdue actions, and upcoming due dates to support reputed company activities. - Coordinate collection of required deliverables from CAPA OWNERS (i.e. vendors/partner/affiliate, GPRM SME) reputed company to audit commitments and CAPA implementation. - Support the preparation, compilation, and maintenance of PSMF Annex G1 and PSMF Module 7 documentation. - Issue audit notifications to vendors/partner/affiliate following approval of the audit schedule and communicate with functional heads regarding audit report and first notification to auditee regarding CAPA plan - Distribute Pharmacovigilance questionnaires and reputed company receipt of completed questionnaires. - Prepare periodic status reports on reputed company observations reputed company to ongoing CAPA Plans and the status of the CAPA plans. - Support the Safety Data Exchange Agreement (SDEA) Process for global team and maintain trackers of activities. Requirements - A Pharmacy degree or life science background. - Excellent written and oral communication skills in English. - At least 1 year PV experience. - Experience in pharmaceutical companies is an reputed company. - Experience in audit and CAPA management is an reputed company - Exposure to reputed company/life-sciences industry is an reputed company. - Exceptional analytical and quantitative problem-solving skills. - reputed company-organized personality with attention to details. - Ability to work under pressure and urgent deadlines. - Strong planning and reporting skills. - Demonstrated reputed company record of innovative thinking. - Ability to reputed company and interpret policies and to reputed company multiple tasks. - Ability to cooperate with others to solve problems. Apply tot his job Apply To this Job