Job Description

Job title: PV Lead and Country Safety Head India

About the job:

Main responsibilities:

• Is responsible for a zone, representing one or more countries under India.
• Serves as the local PV contact for the authorities, is accountable for PV inspections and is nominated as local Responsible Person for Pharmacovigilance (RPP/QPPV) for the CHC products where applicable per national regulations. Designate a back-up who replaces him/her when he/she is out of the office
• Leads and develops the PV team in the assigned Zone and is responsible to perform an effective oversight and management of the PV activities delegated to distributors and/or PV vendors in respective countries within assigned Zone.
• Is recognized as the key leader for all PV related activities at zone level, including but not limited to case management, local safety surveillance, signal detection, risk management and risk mitigation activities, patient support programs market research programs and Distributor management for PV aspects.
• Ensures that local PV activities across the zone are performed in compliance with the Global PV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of CHC products on the market in the assigned country(ies)
• Establishes and maintain robust and efficient local PV systems in the countries of the zone by ensuring the availability and implementation of proper systems/procedures tools and training. Support the QPPV in overseeing the PV activities across the zone.
• Work closely with the relevant stakeholders including QPPV and CHC Head of Safety to ensure adequate resources and budget are allocated.
• Builds close and robust relations/collaboration with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Manager.

KEY RESULTS/ACCOUNTABILITIES

Local and Global Partnership

Local:

• Represent PV in interactions with local GxP and non GxP functions, to optimize coordination and collaboration in areas of overlapping interests:
• Build and maintain robust collaboration/interaction with the in-country partner functions, to carry out and monitor local PV activities, in compliance with PV regulatory requirements and company procedures/guidelines, and particularly.
• Build and maintain robust working relationship with local external PV vendors as well as Global PV vendors operating local activities.

Global:

• Identify issues or dysfunction in the assigned country(ies) and escalate to senior PV Management,
• In case of local PV outsourcing activities, collaborate with Global PV to implement the best outsourced capabilities for the country and Zone
• Interact with Global PV for any questions related to the safety profile of CHC products originating from HA or any other sources

Organization and maintenance of local PV Quality system

• Establish and implement processes in compliance with regional/local PV regulations and global procedures and cooperate with the local Quality Head to document them in local Quality Documents as appropriate
• Ensure maintenance of local quality documents owned by PV to include documented reviews, gap assessments and revisions as per global requirements.
• Develop and maintain the local PV System Master Files for the assigned territories as required and in accordance with local regulations and the global standards.
• Ensure that education and training on PV and relevant safety topics within the local organization are performed including documentation of attendees and topics covered (i.e. PV Awareness, training of service providers and manufacturing sites)
• Manage local compliance metrics generation and ensure data capture in the appropriate tools.
• Document PV process non-compliance to include investigation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation and coordinate related tracking activities with local Quality Head.
• Warrant audit and inspection readiness of the local PV systems (auditable trail of all PV activities performed across the zone is maintained and readily available) with key stakeholders (i.e. Quality, Medical, Regulatory)
• Complete in timely manner audit and inspection observations in close interaction with Global /Local Functions

Organization and Maintenance of PV Operating & Safety Management System

In compliance with PV regulatory requirements and company procedures/guidelines,

• Monitor continuously in-coming communication to ensure the detection and appropriate management of in-coming PV data (ICSRs and other safety related information) to report them in timely manner to Global PV Operations and subsequently to external stakeholders, such as HAs, partners.
• Handle appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with Global PV, Clinical Operations and RA departments to the planning for PSRs ,
• Ensure screening of local scientific / medical literature and management of relevant abstract/articles
• Ensure appropriate implementation and monitoring of PV requirements for global, regional and local programs (e.g. Patient Support Program, Market Research, Managed Access Program...), and company sponsored digital media
• Ensure screening and analysis of national regulations, and forward any future/new/updated PV regulation as per defined processes
• Secure that for all global/local Business Partner agreements, requiring safety provisions, a local SDEA or PV Clause is set-up, implemented and maintained as appropriate.
• In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), Manage contract/work order with local service provider, monitor the appropriate execution of outsourced activities and take the appropriate measures in case of deviations
• Support the Global PV and particularly the QPPV with local safety surveillance activities
• Handle/escalate product safety alerts in timely manner
• Contribute to the development of local RMP, when applicable, with the support and validation of the Risk Management Expert. Track the actual implementation of additional Risk Minimization Measures (aRMMs) across the zone
• Ensure that PV unit is involved in reviewing relevant safety sections of local documents, owned by other affiliates entities, such as labeling, contracts with third parties and local study protocols.

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