Pharmacovigilance lead and country safety head – São Paulo/SP

Responsabilities

• Is responsible for a zone, representing one or more countries.
• Serves as the local PV contact for the authorities, is 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 zone level, including but not limited to case management, local safety surveillance, signal detection, risk management and risk mitigation activities, patient support programs market research programs and Distributor management for PV aspects.
• Ensures that local PV activities across the zone 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 maintain robust and efficient local PV systems in the countries of the zone by ensuring the availability and implementation of proper systems/procedures tools and training. Support the QPPV in overseeing the PV activities across the zone.
• Work closely with the relevant stakeholders including QPPV and CHC Global Consumer Safety Head 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.

Requirements

• Competencies
  • Knowledge of national (Brazilian Pharmacovigilance regulations) and international regulations regarding safety requirements as well as industry standards
  • Leadership skills; problem-solving, prioritize, take initiative and meet challenges
  • Good written and verbal communication skills. Good level of speaking/writing English.
  • Spanish will be considered as a differential.
• Education
  • Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPh or Master Degree with five or more years of pharmacovigilance/clinical development experience.
• Experience
  • Strong experience with pharmacovigilance systems and safety related product management in both clinical development and marketed products;
  • Appropriate experience with Regulatory Agency interactions;
  • Previous leadership experience;
  • Experience with Vendor Management & Oversight, preferably in an international setup.

Marcado como: Farmacovigilância, Indústria Farmacêutica