Senior Area Safety Officer, Local PV France and French Speaking Countries
The Senior Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.
They will ensure that appropriate product vigilance and risk management systems are set in place to ensure appropriate oversight of products within its responsibility.
PRINCIPAL RESPONSIBILITIES:
Oversight of the PV System & Overall responsibilities
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Provide oversight of vendor resources in the countries in scope.
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Support the Area Safety Head in providing relevant local information for the European Economic Area/ UK Pharmacovigilance System Master File (PSMF).
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Regularly review the French PSMF and suggest necessary updates.
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Record self-identified non-conformances and collaborate with the global team to investigate non-conformances while developing and implementing effective Corrective and Preventative Actions (CAPAs).
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Provide regular reporting of the local vigilance activities during dedicated committees.
Safety Management & Reporting
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Support the Area Safety Head in the responses to safety-related health authority queries.
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Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
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Maintain oversight of proper identification of local literature articles for Adverse Event (AE) reporting as required.
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Perform document management and archiving as required.
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Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
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Perform regulatory monitoring for impact on vigilance activities and responsibilities.
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Collaborate with the global and local teams to notify local health authorities of any safety issues including SSI/ESI and Signals.
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Manage planification and reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other client departments as applicable.
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Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetovigilance, materiovigilance and nutrivigilance, including reporting requirements (for all applicable product classes in the territory) and collaborate with the global team to implement process changes required for identification of new requirements.
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Support the Area Safety Head in the pharmacovigilance agreements set-up and updates.
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Perform translation for ICSR and PV-related documents, as required.
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Contribute to the elaboration of safety data during the French good committee use.
Collaboration & Support
- Provide technical and strategic input and participate in projects/ workstreams led by the client Medical Safety teams or LOC.
Procedural Document
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Develop, update, and implement local procedures to ensure compliance with client global procedures and national requirements.
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Ensure current knowledge of all relevant company procedures and training.
Audit & inspection readiness
- Support local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA plans as applicable.
Business Continuity
- Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage) and back-up the Area Safety Head during their absence.
Education:
Health care science professional e.g.: (PharmD, Pharmacist, nurse…)
Years of Related Experience:
Minimum 3 years’ of Pharmaceutical or CRO experience.
Knowledge, Skills, Abilities:
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Pharmaceutical industry experience including product vigilance is a must for this role
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Proven ability to organize workflow activities in an autonomous manner.
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Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology.
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Knowledge of global, regional, and local procedural documents as applicable.
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Computer literate with knowledge of relevant IT safety systems.
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Good verbal and written communication skills.
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Ability to establish and maintain open relationships within the organization and with authorities.
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Demonstrable knowledge of all local requirements and of global aspects of product safety.
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Fluency in the English language.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.