Position will need to be staffed by a Saudi National
JOB PURPOSE
The Country Safety Head (CSH):
* Is responsible for a country
* Serves as the local PV contact for the authorities, 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
* Is recognized as the key leader for all PV related activities at country level, including but not limited to case management, local safety surveillance, signal detection, risk management and risk mitigation activities, patient support programs and market research programs
* Ensures that local PV activities 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 maintains a robust and efficient local PV system by ensuring the availability and implementation of proper systems/procedures tools and training. Work closely with the respective Regional PV Head / SA Country Manager 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.
Global:
* Identify issues or dysfunction in the assigned country(ies) and escalate to the Affiiates PV Head,
* In case of local PV outsourcing activities, collaborate with Global PV to implement the best outsourced capabilities
* Interact with the 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 File in accordance with 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 system (auditable trail of all PV activities performed locally 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,
* Screen local scientific / medical literature and manage relevant abstract/articles accordingly
* Ensure appropriate implementation and monitoring of PV requirements for global, regional and local programs (e.g. Patient Support Program, Market Research, Managed Access Program etc), and company sponsored digital media
* Screen and analyse national regulations, and forward any future/new/updated PV regulation to the respective CHC Regional PV Head
* 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 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)
* Ensure that PV unit is involved in reviewing relevant safety sections of local documents, owned by other affiliates entities, such as labelling, contracts with third parties and local study protocols.
Quality oversight:
* Ensure appropriate communication of key messages pertaining to quality across the country organization highlighting their possible business impact.
* Act as the primary country contact for quality issues and coordination of other GxP country functions during country regulatory inspections.
* Support the local HA in their GMP inspections of foreign sites.
* Ensure that local critical and major pharmacovigilance or safety related audit findings are managed as per global company and local regulatory requirements.
* Ensure that valid and signed Quality agreement are in place (with internal CHC manufacturing sites, distribution centers and / or external manufacturing hubs, CMOs, distributors) for all GDP / GMP activities under Quality responsibility within the CHC Affiliate organization and that all quality-related clauses are in place in service agreements for all subcontractors of GxP and health-regulated activities for the KSA CHC Affiliate.
* Ensure that the PTCs received are managed efficiently.
* Manage notifications from and to local HAs for CHC products related to quality events in liaison with other local functions, as required.
* Lead and coordinate product recalls as per global process and local regulatory regulations.
* Ensure that any additional requirements imposed on certain products by the local HA, due to local regulations, are addressed and adhered.
* Abide by the requirements of the internal Code of Ethics, including but not restricted to maintaining high professional standards of conduct in line with company procedure with a duty of care to the reputation of the company.
KEY WORKING RELATIONSHIPS
* CHC Regional PV Head
* CHC PV Affiliates Head
* Country Scientific Affairs Medical/Regulatory Teams and Country Scientific Affairs Head
* CHC EU QPPV
* Global CHC PV Operations Team
* Global CHC Medical Safety Team
* CSH Network
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.
* Must demonstrate the Play to Win Behaviors of Stretch / Take Action / Act for Customers and Patients and Think Sanofi first.
Education
* Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPh or Master's Degree with two 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
Key Dimensions
* Reports to respective CHC Regional PV Head with dotted line to Country Scientific Affairs 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.