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Senior Pharmacovigilance Manager
1 week ago
Iqvia Argentina is a leading safety group, dedicated to optimizing the benefit-risk of our therapies and serving our patients and consumers. Our dynamic and culturally diverse team is committed to ensuring the safety of Sanofi products in regions and countries.
Job Overview:
The Country Safety Lead will replace the Country Safety Head in most tasks when they are out of the office, including acting as local PV contact for authorities and being accountable for PV inspections.
Main Responsibilities:
- Act as Local Safety Officer (LSO) by managing medical safety of assigned local products under the oversight of the Regions Medical Safety Head.
- Support the CSH in ensuring that local PV activities are performed in compliance with PSPV policies, global, regional and local PV regulations.
- Serve as the local PV contact for local authorities and acts as the local Responsible Person for Pharmacovigilance (RPP) where applicable per country legislation.
- Maintain robust collaboration with in-country partner functions to carry out and monitor local PV activities.
- Secure detection and transmission to PV unit of incoming PV data in a timely manner.
- Contribute to the development of local implementation plan of additional Risk Minimization Measures (aRMMs).
- Identify issues or dysfunction in the assigned country(ies) and escalate to CSH.
- Interact closely with Regions Governance Team.
- Ensure education and training on PV and relevant safety topics within the local organization.
- Manage local compliance metrics generation, Root Cause Analysis (RCA), Corrective Actions / Preventive Actions (CAPAs) implementation.
- Warrant inspection readiness of the local PV system.
- Monitor continuously incoming communication to ensure the detection and appropriate management of incoming PV data.
- Handle appropriately local periodic safety reports and contribute to the planning for PSRs.
- Ensure appropriate screening of local scientific/medical literature and process the relevant abstract/articles accordingly.
- Participate in the local business continuity plan and after hours' emergency calls process.
- Support the GSO with local safety surveillance activities.
We are looking for a highly skilled individual with experience in pharmacovigilance systems and safety-related product management in both clinical development and marketed products.
Requirements:
- Advanced health care discipline degree (MD, MPharm, PhD, Master of Science, etc.) or equivalent qualification.
- Experience with pharmacovigilance systems and safety-related product management in both clinical development and marketed products.
- Leadership skills, able to create networks and collaborate in an international cross-functional environment.
- Robby knowledge of pharmacovigilance systems & regulations.
Sanofi is an Equal Opportunity Employer. We strive to be a cutting-edge safety group, enabling us to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers.
