• Job Description

  Req#: R2747359

  ABOUT THE JOB:

  The Country Pharmacovigilance Specialist Supports the Country Safety Head to:

  • Manage the following countries: South Africa, Botswana, Namibia, Lesotho, Swaziland, Angola, Cape Verde, Equatorial Guinea and Seychelles
  • Maintain an operational Pharmacovigilance System for countries under the responsibility of the CSH
  • Ensure that local PV activities are performed in compliance with the PSPV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of Sanofi products on the market in the assigned countries
  • Establish and maintain a robust and efficient local PV system by ensuring the availability and implementation of proper systems/procedures, tools and training.

  KEY ACCOUNTABILITIES

  Role

  • Supports CSH and South Africa PV team to maintain a robust PV Operating, Safety Management and Quality system
  • Local, Region and Global Partnership

  Local:

  • 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
  • Secure with Medical Information, Clinical Study Unit, Quality and Marketing and local third party (e.g. CRO, vendors) the detection and transmission to PV unit of incoming PV data in timely manner
  • Develop local implementation plan of additional Risk Minimization Measures (aRMMs) and enable its implementation by working cross-functionally with Country GBU Medical Head (or delegate), the Country Regulatory Manager and other appropriate functions
  • Training of internal and external stakeholders on PV requirements
  • Region/Global:
  • Identify issues or dysfunction in the assigned country(ies) and escalate to CSH, and in absence of CSH, to Regions PV Head, and/or via Multi-Country Safety Head
  • Interact closely with Regions Process Coordination Team within Regions Governance Team
  • In case of local PV outsourcing activities, interact with vendors to ensure compliant PV processes
  • Refer to the Global Safety Officers (GSO) for any questions related to the safety profile of Sanofi product originating from HA or any other sources.
  • Collaborate with Regions Systems & Standards Harmonization Team within Regions Governance Team and other PSPV unit such as PV Operations Team, SDEA Team, etc. to contribute to the appropriate management of Local PV system.

  Supports the CSH in the maintenance of local PV Quality system:

  • Establish and implement processes in compliance with regional/local PV regulations and global Sanofi group procedures and cooperate with the CQH to document them in local Quality Documents as appropriate.
  • Develop and maintain of the local PV System Master File is in accordance with the global standards.
  • Ensure that education and training on PV and relevant safety topics within the local organization are performed including the documentation of attendees and topics covered (i.e. PV Awareness, training of service providers and manufacturing sites)
  • Manage local compliance metrics generation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation and related tracking activities (ICSRs/ PSRs/HA queries)
  • Warrant 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 and Regulatory)
  • Complete in timely manner audit and inspection observations in close interaction with Global/Local Functions

  • Supports the CSH in the maintenance of PV Operating & Safety Management Sytem:
  • 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 PSPV/Global PV entities and external stakeholders, such as HAs or partners
  • Handle appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with PSPV and RA departments to the planning for PSRs
  • Screen local scientific/medical literature and forward the relevant abstract/articles to PSPV.
  • 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
  • Screen and analyze national regulations and forward any future/new/updated PV regulation (draft or final) to PSPV via Regulatory Intelligence unit.
  • Participate in the local business continuity plan and after hours’ emergency calls process
  • Ensure accurate local implementation of global Safety Data Exchange Agreements (SDEAs), when applicable
  • Secure that for all 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 product in-licensing or local company acquisition: participate, in close collaboration with PSPV, in the due diligence and integration process.
  • 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 GSO with local safety surveillance activities:

  • Acts as local sentinel supporting the global safety signal detection for all products in the country(ies)
  • Ensures that any safety-related questions received from local Health Authorities and any local safety issues are raised and managed in timely manner
  • Handle/escalate product safety alerts in timely manner
  • Ensure 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 labeling, contracts with third parties and local study protocols

  ABOUT YOU:

  JOB-HOLDER ENTRY REQUIREMENTS

  Competencies:

  • Strong knowledge and expertise in international and national (Pharmacovigilance) regulations as well as industry standards
  • Sufficient ability to interpret clinical data including safety data
  • Interpersonal skills of diplomacy and team player dynamics; knowledge of and respect for cultural differences; professionalism and mediation are important
  • Demonstrate problem solving skills, sense of urgency, especially with respect to enforcing safety rules and global procedures as described in QDs, Operational Manuals and Guidance documents. Capacity to work under pressure
  • Ability to work in international and transversal teams.

  Education:

  • Pharmacy Doctor, Pharmacist, Nurse
  • A master’s degree will be advantageous

  Experience:

  • Experience with pharmacovigilance systems and safety-related product management in both clinical development and marketed products is highly recommended.
  • Management of safety aspects of clinical trials
  • A minimum of 12 months experience in pharmacovigilance
  • Experience on required standards for high quality safety relevant documents, e.g. case management, RMP, Periodic reports, Signal detection is advantageous
  • Experience with Regulatory Agency interactions is advantageous.

  PLAY TO WIN BEHAVIORS

  • Push to go beyond the level we have operated until now:
    constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won’t: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment
  • Put the interest of the organization ahead:
    consider both short- and long-term impact of decisions; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level
  • Act in the interest of our patients and customers:
    actively engage with customers to know their current and future needs; brings an external perspective into decisions.
  • Act and don’t wait to be told what to do:
    take smart and informed best bets with the information at hand and anticipate the consequences of her/his actions; use personal judgement and others’ advice to make bold and impactful decisions which move us forward.

  Pursue Progress, Discover Extraordinary

  Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

  At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

  Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

  Pursue progress, discover extraordinary

  Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

  At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

  Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

• About the company

  Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health.

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