Manager QPPV Office

Sandoz India; Telangana; On-site; INR 2,500,000 - 3,500,000; Full time

Job summary

Sandoz India is seeking an experienced Pharmacovigilance professional to lead end-to-end maintenance and submission of UK PSMF/sPSMF and to support EU PV documentation. You will coordinate with the QPPV Office and Operations Manager to ensure regulatory compliance, timely updates, and inspection readiness, while managing cross-functional contributors and CAPA processes.

Strong project management, communication, and ability to drive continuous PV process improvements are essential for success in

Qualifications

• Eight years of pharmacovigilance experience, preferably in a European environment.
• Strong knowledge of regulatory requirements for pharmacovigilance.
• Experience with audits/inspections by Health Authorities.
• Proven track record in project management and cross-functional collaboration.
• Excellent communication and organizational skills.

Responsibilities

• End-to-end maintenance, development and submission of UK PSMF/sPSMF; support EU PSMF.
• Support deviations and CAPAs across the Patient Safety organization.
• Support inspection and audit operations, including CAPA development, tracking and management.
• Support development, implementation and dissemination of PS procedures.
• Support the QPPV in meeting regulatory requirements.
• Assist QPPV office with additional activities as assigned.

Skills

Pharmacovigilance knowledge

GxP experience

Audits/inspections

Project management

Communication skills

Organisational skills

Multitasking

Job description

Your Key Responsibilities

• Ensure the end-to-end maintenance, development and submission of the UK PSMF/sPSMF and support that of the EU PSMF.
• Support the development, management and implementation of deviations and associated CAPAs across the Patient Safety organization
• Support inspection and audit operations, including CAPA development, tracking and management
• Support the development, implementation and dissemination of PS procedures
• Support QPPV in meeting legislative requirements as per relevant legislation
• Any other activities to support the QPPV office as assigned

Person Specific / Special Tasks

• Ensure the end-to-end maintenance of the UK PSMF working with the appropriate local and global stakeholders for the Core and Annex documents. This includes lead authoring and update of the UK PSMF, and Pharmacovigilance System Summary (sPSMF) for the pharmacovigilance system of Sandoz. This includes the management of cross-functional contributors of the Sandoz PSMF and independent identification of changes to the global PV system which require an update particularly to the UK PSMF in close collaboration with Operations Manager, QPPV Office.
• Work closely with Operations Manager, QPPV Office to ensure accurate representation of the Sandoz PV system in line with regulatory requirements and incorporate identified changes into the PSMF in a timely manner.
• Track timely provision of information from stakeholders for UK/EU PSMF production, escalating issues to the Operations Manager, QPPV Office. Format and publish final PSMF, ensuring consistency.
• Support Operations Manager, QPPV Office in provision of documents required by CPSRs to create local PSMFs / Pharmacovigilance Subsystem Files (PSSFs) as required. Support Operations Manager, QPPV Office in tracking of submission of PSMF documents as required.
• Ensure UK and EU PSMF are inspection-ready and be the key point of contact in audits and inspections for the UK PSMF and support for EU PSMF.
• Support the QSO in ensuring processes and procedures are developed on time and efficiently supporting streamlining of PV processes.
• Support Head of Audits and Inspections from preparation to CAPA implementation.
• Review process based on experience, feedback and requirements, lead continuous process improvement.

Essential Requirements

What you’ll bring to the role:

• Eight years experience in pharmacovigilance preferably gained in a European environment within Drug Safety Department, Drug Regulatory Affairs, Clinical Development or Quality Assurance
• Good knowledge of European regulatory requirements preferentially relating to pharmacovigilance
• Pharmacovigilance systems, or similar GxP experience (covering compliance, databases, procedures, QA, training)
• Experience in the area of audits/inspections by various Health Authorities
• Proven track record of successful project management, excellent communication skills and organisational and administration skills
• Proven ability to work and handle multiple tasks independently and effectively