PV & Regulatory Specialist

Sun Pharma | Manila, Metro Manila | PH

JOB RESPONSIBILITIES

  • Will handle Pharmacovigilance - receiving, processing, reporting and follow-up of ADR; maintaining and compliance of SOP, training for the non-PV personnels, submission of PSUR, respond to the requirements of global Pharmacovigilance and will attend to internal and external audits.

  • Pre-submission review and submission of initial/renewal registrations, variation documents of drug products in FDA as required.

  • Coordinates with CRA counterparts in the head office for clarification of requires, providing regulatory assessment, updates of new laws issued by FDA Philippines as required.

  • Reviews and provides assistance for development of packaging materials for product submission and launching.

QUALIFICATIONS

  • Bachelors Degree in Pharmacy/Pharmacology or equivalent

  • Must be a licensed Pharmacist

  • With at least 2 years of working experience in Pharmacovigilance and at least 3 years years in Regulatory

  • Knowledge in Pharmacovigilance and FDA submissions is a must

  • Knowledge of the Bioequivalence and Biowaiver is an advantage

  • Willing to work in BGC

  • Full-Time position


Information :

  • Company : Sun Pharma
  • Position : PV & Regulatory Specialist
  • Location : Manila, Metro Manila
  • Country : PH
Next Process

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Post Date : 2025-06-16 | Expired Date : 2025-07-16

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