Country Safety Team Lead, South Asia

Ensuring that the Local Operating Company (LOC) safety activities, related to medicinal products are managed in compliance with local regulations and company policies/procedures at local, regional, and global levels and in accordance with any Pharmacovigilance (PV) agreements with third party business partners.

Having appropriate pharmacovigilance risk management systems and adequate record management in place to assure appropriate oversight for products within its responsibility.

Managing Local Medical Safety activities to:

• Ensure proactive Benefit Risk Management throughout product life cycle translating global safety data to insights and actions tailoring to local specificities and needs.

• Support activities related to safety reporting requirements as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable.

Managing and coaching Local Medical Safety Team staff.

Serving as a member of the Asia-Pacific (APAC) IPV Leadership Team.

Providing strategic leadership of the territory cluster and supporting LOC(s) to meet all global, regional, and local PV responsibilities.

Participating and leading International Pharmacovigilance (IPV) projects and initiatives locally and regionally within APAC cluster.

Participating (and may lead) in IPV regional projects and initiatives and providing a supportive role in IPV global projects and initiatives.

Principal Responsibilities

1.

Act as Local Nominated Person (including back-up nominated person)

Act as locally nominated person for Pharmacovigilance (PV) assuming the PV role as defined by national law/regulation.

Collaborate with the Qualified Person for Pharmacovigilance (QPPV) offices as required.

Represents the company as the Pharmacovigilance Officer in-charge for India

2.

Oversight of the PV System & Overall responsibilities

• Oversight of the applicable product portfolio, and link with local management and key stakeholders.

• Maintain oversight of all required PV regulatory reporting compliance in a timely manner.

Provide insights into metrics and lead actions as needed.

• Ensure that day-to-day PV functions are performed satisfactorily, and that full regulatory compliance is maintained at LOC level including adequate record management.

• Collaborate with the local MAH to enable fulfilment of its regulatory responsibilities [including Pharmacovigilance Agreement (PVA)] and meet their business objectives.

• Advise the local business on the PV impact of local organized data collection programs.

• Escalate compliance issues in a timely manner to Regional Safety Head, APAC, to ensure appropriate mitigation is implemented.

• Monitor and forecast PV workload to identify, mitigate and escalate potential PV resource and non-compliance issues.

• Identify periods of high PV workload and manage PV resource appropriately to address them.

• Support and lead process improvements to optimize the PV system and make best use of PV resource.

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