Drug Safety Specialist

Found in: beBee jobs PH - 7 days ago


Makati City, National Capital Region, Philippines Parexel Full time

Accountabilities:

Is responsible for Phillipines PV and Consumer Safety.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 client products where applicable per national regulations. Designate a back-up who replaces him/her when he/she is out of the officeIs recognized as the key leader for all PV related activities at country 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 for PV aspects.Ensures 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 client products on the market in the assigned country.Establishes and maintain robust and efficient local PV systems in the designated country by ensuring the availability and implementation of proper systems/procedures tools and training. Support the QPPV in overseeing the PV activities in the country.Support the client country Head of Consumer Safety with regards to local budget planning and management.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.Act as Deputy CSH for a partner country when applicable.CompetenciesKnowledge of national PV regulations and international regulations regarding safety requirements as well as industry standardsPragmatic, solution oriented mindset; problem-solving, prioritize, take initiative and meet challengesGood written and verbal communication skills. Good level of speaking/writing English.EducationMedical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPh or Master Degree in Lifescience, with three or more years of pharmacovigilance/clinical development experience.Clinical Medicine or Pharmacy background is preferred.ExperienceExperience with pharmacovigilance systems and safety related product managementAppropriate experience with Regulatory Agency interactionsTraining received in GCP and GVP
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