PV Lead & Country Safety Head Russia / Руководитель по фармакобезопасности

In a European pharmaceutical company, a position for a PV Lead & Country Safety Head Russia is opened.

Job purpose:

The PV Lead & Country Safety Head (PVZH):

• 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 products where applicable per national regulations.
• Is recognized as the key leader for all PV related activities at zone level.
• 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.
• Establishes and maintains 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 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 Partnership

• 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 activites.

Global Partnership

• Identify issues or dysfunction in the assigned country and escalate to senior PV Management.
• In case of local PV outsourcing activities, collaborate with Global PV to implement the best outsourced capabilities.
• Interact with Global PV for any questions related to the safety profile of 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.
• 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.
• 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 with key stakeholders.
• Complete in timely manner audit and inspection observations in close interaction with Global /Local Functions.

Organization and Maintenance of PV Operating & Safety Management System

• Monitor continuously in-coming communication to ensure the detection and appropriate management of in-coming PV data to report them in timely manner to Global PV Operations and subsequently to external stakeholders.
• 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.
• 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.
• 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.
• 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.

Skills, experience & knowledge requirements:

• Knowledge of national PV regulations and international regulations regarding safety requirements as well as industry standards.
• Leadership skills; problem-solve, prioritize, take initiative and meet challenges.
• Good written and verbal communication skills.
• Good level of speaking/writing English.
• Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPh or Master Degree with five or more years of pharmacovigilance/clinical development experience.
• Experience with pharmacovigilance systems and safety related product management in both clinical development and marketed products.
• Appropriate experience with Regulatory Agency interactions.
• Experience with Vendor Management & Oversight, preferably in an international setup.