Cipla - Manager - Pharmacovigilance - Quality Assurance

Job Description

JOB DESCRIPTION Job Title: Manager Sub-function: Pharmacovigilance- Quality Assurance (PV-QA) Function Corporate Quality Assurance Location - Vikhroli Job Details Job Purpose Pharmacovigilance (PV) Audits and risk assessment: Planning and conducting audits of PV processes, business partners, Cipla Offices, service providers and other departments related to PV function. Preparation and implementation of strategic and tactical level audit plan. To perform PV risk assessment. Facilitating external audits and regulatory inspections: Experience on handling of PV regulatory inspection eg. USFDA, MHRA, EMA, TGA etc. Quality Management System (QMS): Handling on deviation, CAPA, change management, documentation control on electronic software. Preparation, review and approval of QMS and PV SOPs. Record management process. End to end PV knowledge: Different source of safety information, PV mailbox case processing and literature screening, regulatory submission, knowledge of dictionaries (MedDRA, WHO DD, CPD), PV vendor management, Lavel update, PV/QMS training, Safety data exchange agreement, PSMF, Aggregate reports (RMP, PSUR/PBRER, PADER) and signal management. Key Accountabilities Accountability Cluster Major Activities / Tasks Pharmacovigilance Audits and Inspection Planning and conducting audits of PV processes, business partners, Cipla Offices, service providers and other departments related to PV function. Perform Vendor Qualification and its related activities. Conduct risk assessment of all PV processes, departments of Cipla other than DSD involved in PV System, Cipla Country offices, Cipla subsidiaries, business partner and service providers. Preparation and implementation of Audit schedule Facilitating external audits and regulatory inspections Deviation Handling and CAPA management Logging, approving, tracking and closing the deviations and CAPA raised in DSD. Initiation, Follow up and monitoring of open CAPAs. Closing and effectiveness review of CAPAs. Document Control Issuance, distribution, withdrawal, destruction of all the forms generated through approved written procedures for DSD. Preparation and review of written procedures related to Drug Safety Division (DSD) Quality Management System (QMS). Document retention and archival of all the DSD related documents. Training Training to DSD on QMS and related topics Identify need of training on QMS and related topics Change Request Coordinate change requests raised by DSD Review of PSMF, PvMF, or equivalent documents through change control system End to end Pharmacovigilance related activities Collection of safety information from Different source, PV mailbox case processing and literature screening, regulatory submission, knowledge of dictionaries (MedDRA, WHO DD, CPD), PV vendor management, Lavel update, PV/QMS training, Safety data exchange agreement, PSMF, Aggregate reports (RMP, PSUR/PBRER, PADER) and signal management. QMS software Trackwise, Vivo or any QMS software Major Challenges Communication with Cross function team to implement CAPA plan. Collection of data required to perform risk assessment Timely close of QMS activity Key Interactions InternalExternal Team Member, for discussion on concern to their activity / task and each and every assigned task on daily basis. DSD Team: Interaction with DSD team for closure of QMS document. CFT: Medical service depart, Corporate communication department, Corporate quality assurance, Clinical research department, CSV, IT, REMS. CFT: Cipla country offices and Subsidiaries External: Pharmacovigilance vendor, business partner for discussion of Audit requirement and implementation of CAPA plan. Dimensions Meet 100% compliance to Tactical level audit plan and risk assessment Ensure change request, Deviation and CAPA shall get raised within timeline. Meet 100% compliance timely closure of QMS documents i.e. Deviation, CAPA and change management. Ensure timely training imparted in QMS topics for key PV personnel. Ensure completeness, accuracy of QMS documents. Timely resolution of internal and external queries. Key Decisions: DecisionsRecommendations Inputs on resolution of queries from CFTs. Approve Process Deviations Make process improvements as needed. Mentoring CAPA owners on proper techniques Inspection Readiness Assistance to cross functional team To Share industry best practices To increase the awareness on regulatory intelligence. Process simplifications. Comments: The said Job description will involve adequate knowledge PV audit, QMS and End to end knowledge of PV system. Skills & Knowledge Educational qualifications: Qualified pharmacist (B. Pharma / M. Pharma). Relevant experience: He / She must have 10-14 years of Pharmacovigilance experience including audits and QMS. He / She must be technically sound on QMS function and exposure of regulatory audits like USFDA, MHRA, TGA, EMA, SHAPRA etc.