Cipla - Manager - Pharmacovigilance - Quality Assurance

Sub-function:

Function

Location - Vikhroli

1. Job Details

1. Job Purpose

Pharmacovigilance (PV) Audits and risk assessment:

1. Key Accountabilities

Accountability Cluster Major Activities / Tasks

1. 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

1. 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.

1. 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.

1. Training

• Training to DSD on QMS and related topics
• Identify need of training on QMS and related topics

1. Change Request

• Coordinate change requests raised by DSD Review of PSMF, PvMF, or equivalent documents through change control system

1. 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.

1. QMS software

• Trackwise, Vivo or any QMS software

1. Major Challenges

• Communication with Cross function team to implement CAPA plan.
• Collection of data required to perform risk assessment
• Timely close of QMS activity

1. 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.

1. 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.

1. 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:

1. Skills & Knowledge

Educational qualifications: