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CHC PV Deputy Country Safety Head

Geplaatst 28 nov. 2023
Delen:
Werkervaring
0 tot 7 jaar
Full-time / part-time
Full-time
Functie
Soort opleiding
Taalvereiste
Engels (Vloeiend)

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At Sanofi CHC, we have one shared purpose - we work passionately, every day, to ‘serve healthier, fuller lives. Our marketing philosophy is driven by this purpose and everything we do is centered around people, our customers, healthcare professionals, and our employees, across the world.

We are building brands that serve 1bn consumers worldwide, so that they can live healthier, fuller lives. In order to do this better than anybody else, we aspire to become the most consumer-centric Fast Moving Consumer Healthcare Business. We want to be market shapers and achieve category leadership in the categories that we play in - delivered through strong global-local partnership. We are a people first business, placing consumers at the heart of everything we do through uncovering and activating deep consumer and shopper insights, for example.

As a top 3 global CHC player, we want to raise the bar in terms of our strategic and operational capabilities to enable sustainable, above-market growth. In order to achieve this, we need strong talents that will help us shape the future of CHC while sharing our core values of courage, teamwork, respect, and integrity.

JOB PURPOSE

The CHC PV Deputy Country Safety Head (DCSH):

  • Supports the Country Safety Head in country related PV activities.
  • Deputizes for the CSH in times of planned or unplanned absence of the CSH.
  • Is nominated as deputy local Responsible Person for Pharmacovigilance (RPP/QPPV) for the CHC products where applicable per national regulations.
  • Supports the CSH in ensuring that local PV activities in the assigned country 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.
  • 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

Organization and maintenance of local PV Quality system

  • Support the maintenance of local quality documents owned by PV to include documented reviews, gap assessments and revisions as per global requirements.
  • Support the maintenance of the local PV System Master File for the assigned country as required and in accordance with local regulations and the global standards.
  • Contribute to education and training on PV and relevant safety topics within the local organization.
  • Maintain local compliance metrics and ensure data capture in the appropriate tools.
  • Support PV process non-compliance investigation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation including appropriate documentation.
  • Support the completion of 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 management of relevant abstract/articles
  • Support the implementation and monitor the PV requirements for global, regional and local programs (e.g. Patient Support Program, Market Research, Managed Access Program...), and company sponsored digital media
  • Contribute to screening and analysis of national regulations, and forward any future/new/updated PV regulation as per defined processes
  • In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), support the monitoring of the appropriate execution of outsourced activities.
  • Support the Global PV and particularly the QPPV with local safety surveillance activities
  • 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) in the assigned country.

KEY WORKING RELATIONSHIPS

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

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

Competencies

  • Robust understanding of national PV regulations regarding safety requirements.
  • Pragmatic, solution oriented mindset; problem-solving, prioritize, detail-oriented, 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 Degree with two or more years of pharmacovigilance experience.

Experience

Experience with pharmacovigilance systems and safety related product management

Cultural traits / P2W Behavior

  • 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 of own of those of his/her team: 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 the local perspective into decision making.
  • Required Leadership Competencies
  • Interpersonal relationships - treating others with courtesy, sensitivity, and respect.
  • Change Leadership - The ability to demonstrate support and drive for innovation and organizational transformation
  • Personal Leadership - Personal leadership translates into courage, choice, and commitment through the pursuit of excellence, trust, and accountability. Ability to put patient, stakeholder, and organizational interests above personal interests
  • Desire and need to achieve challenging goals, to improve performance or to meet personal standards of excellence
  • Learning Agility – Ability to navigate first time/unfamiliar situations effectively by extrapolating from other areas of expertise and knowledge. Ability to continuously improve and develop.

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.

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions.

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Amsterdam
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