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PV/RA AND COMPLIANCE SPECIALIST [HJ1213-08]

Job title: PV/RA AND COMPLIANCE SPECIALIST [HJ1213-08]
Contract type: Permanent
Location: Central - Selangor
Specialisation:
Industry: Healthcare & Pharmaceutical
Salary: 7000.00 - 9000.00
Start date: 29 Mar 2021
Job Reference: 45743
Contact details: How Jing May
Contact email: jingmay.how@jac-recruitment.com
Contact-phone: +60 3 2202 1000
Job published: 11 days ago

JOB RESPONSIBILITIES

  • Develop and maintain local PV SOPs/WPs.
  • Prepare, review, update, and maintain PV clause in the agreement from PV perspective.
  • Manage and/or conduct oversight of RMP-related PV activities including risk minimization measures.
  • Maintain current knowledge of all local regulatory PV requirements in the territory, communicate with relevant global/regional PV and ensure compliance with them.
  • Product registration and product life cycle management (renewal of license, submission of variations).
  • To liaise between manufacturer and Sales & Marketing team regarding label changes.
  • To provide regulatory input and assistance in the development and implementation of regulatory strategies.
  • Establish local Compliance and Privacy SOPs based on Company Group Global Policies and guidelines, applicable laws and regulations (including the industry code).
  • Revise local Compliance and Privacy policies and SOPs on a timely basis.
  • Provide regular trainings to relevant functions on Company Group Global Policies and local SOPs, and ensure completion of group Compliance and Privacy training program.
  • Perform Compliance risk-assessment, develop and implement a Compliance and Privacy monitoring plan.

JOB REQUIREMENTS

  • Degree in Pharmacy/Pharmacology.
  • Minimum 1 year experience in pharmaceutical industry, particularly in the field of PV and/or RA.
  • Proven ability to effectively build lasting relationships by demonstrating strong interpersonal and influencing skills throughout all levels of the organization.
  • Ability to maintain confidentiality of sensitive areas.
  • Excellent verbal and written communication skills in English.