Manager

MSN Laboratories · India

PVQA Manager / Senior Manager - Pharmacovigilance Department

Roles and Responsibilities:

• Support the Global Pharmacovigilance Quality Assurance in defining the strategy for and establish a robust, integrated PV Quality management system.
• Drive the development, implementation and oversight of all quality aspects of the pharmacovigilance Quality Management Systems (QMS)
• To work closely with the Global Head of PV and Head, Quality Management (QM), Regional/Functional Heads to help define PVQA or PV QMS strategies and ensure the fulfilment of regulatory requirements.
• Acts as a back-up/ Designee to Global Head of PV as required.
• Support in the creation, revision and withdrawal of PV related procedural documents.
• Ensure PV processes have appropriate documentation and identify any process gaps. Maintain document review and life-cycle.
• Review and provide input to PV documents as needed to ensure PV processes are adequately documented.
• Provide PVQA support in the roll-out phase of IT tools in the pharmacovigilance function
• Support in achieving robust, inspection ready quality management system for PV which meets internal quality standards global regulatory requirements for PV quality.
• Provide support for the conduct and management of regulatory authority inspections.
• Support preparation efforts including training of personnel on inspection behaviour and how to answer inspection questions, assist in the generation of story boards to cover key areas and to provide SME lists for interview. Manage the logistics for the inspection conduct, including the availability of rooms, scribe and technology as required.
• Support the Head, Quality Management and the Head of Global Pharmacovigilance in defining the risk-based approach to the selection of affiliates and commercial partners (licensing partners, distributors, and vendors) for the audit.
• Ensure routine, regular end to end audit of the PV system.
• Support the conduct of third part audits of MSN as needed to ensure appropriate management of regulatory inspections for PV.
• Support in fulfilling regulatory requirements for a full systematic approach to auditing the PV system.
• Work with Head of Global Pharmacovigilance and Head Quality Management (QM) to establish a process for the tracking of self-identified, unplanned and planned deviations from PV processes
• Ensure CAPA from audit and inspections are appropriate and adequately address the findings. Define a process for tracking of CAPA from audit and inspection to resolution and ensure CAPA effectiveness checks are made in accordance with the regulatory requirement.
• Ensure that the streamlined process is established for escalation of overdue CAPA to ensure robust processes for deviation and CAPA management as requirement of a functioning QMS.
• To drive the development of cross functional CAPAs where the buy-in from other departments in addition to PV is needed to reach desired outcomes.
• Support in identifying areas for the development /process improvement to promote efficiencies.
• Participate/ contribute to organisation wide initiatives and response to the new regulatory requirements. Maintain a contemporary knowledge of current industry trends, standards and methodologies as it relates to PV quality management.
• Actively participate and Global compliance committee meeting and involve in the comprehensive discussion of all PV quality related matters.

Qualifications:

Educational Qualification:

Masters in any discipline. Pharmacy/Medicine

Minimum Work Experience: 10-12 Years overall PV and at least 6-8 years in the PV QA