COMPLETE PV Zone Head ASEA/ Country Safety Head Singapore - City of Singapore

JOB PURPOSE

The CHC PV Zone Head ASEA & Country Safety Head (PVZH):

• Responsible for a zone, representing one or more countries in the ASEA Zone.
• 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 team of CSHs 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 activites.

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.

KEY WORKING RELATIONSHIPS

• Regional PV Head
• Country Medical/Regulatory/Quality Teams and Country Manager
• ASEA Zone Science Head
• QPPV
• Global PV Operations Team
• Global Medical Safety Team
• Network of PV Zone Heads and CSHs

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

Competencies

• 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.

Education

• Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPh or master's degree with five or more years of pharmacovigilance/clinical development experience.

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.

Role impact and Scope:

The performance of the PV Zone Heads is of critical importance as these roles are driving the PV compliance level in typically one very important market with strict PV regulations as well as one or more satellite markets which are managed and overseen by the Zone Head.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.