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Regulatory Affairs and Pharmacovigilance Director

  • Location: Kingdom of Thailand
  • Salary: Plus Benefits per annum
  • Job Type:Permanent

Posted about 1 month ago

  • Sector: Industrial
  • Contact: Paul Coles
  • Start Date: ASAP
  • Expiry Date: 12 June 2021
  • Job Ref: JN -052021-459606

REGULATORY AFFAIRS AND PHARMACOVIGILANCE DIRECTOR - PHARMACEUTICAL - LIFE SCIENCES - MEDICAL - HEALTH - BANGKOK - INTERNATIONAL COMPANY - UP TO 250,000 + BAHT A MONTH DEPENDING ON EXPERIENCE PLUS BONUSES AND BENEFITS - THAI ONLY

  • Regulatory Affairs and Pharmacovigilance Director / Pharmaceutical / Life Science / Medical / Health
  • International Pharmaceutical & Life Science Producer and Distributor
  • Up to 250,000 BAHT A MONTH DEPENDING ON EXPERIENCE PLUS BENEFITS & BONUSES depending upon skills and experience

The Client

My client is an International Pharmaceutical & Life Science Producer and Distributor.

The Role

Manage all regulatory and pharmacovigilance activities within the business ensuring complete compliance with all regulatory and pharmacovigilance controls and standards.

KEY RESPONSIBILITIES:

  • Oversees all daily PV and RA processes and activities within the countries covered by the country operation.
  • Develops product registration plans & strategies in accordance with local regulations and global standards, working cross-functionally to review & communicate the registration strategy.
  • Establishes and coordinates reconciliation processes of AE reports received from local operating units
  • Participates in compliance activities and coordinates the preparation of necessary corrective actions locally for late reporting countries covered by the country operation
  • Prepares for audits/inspections for countries covered by the country operation and actively participates in the audit and/or inspection. Provides recommendations of corrective and preventive actions
  • Participates in and supports audits of contractual partners/vendors as necessary.
  • Defines and develops local standards and procedures (in compliance with regional and global standards) for the department, to ensure quality PV and RA data and evaluates processes for potential improvement in efficiency and effectiveness.
  • Develops and maintains local PV and RA controlled documents (i.e., SOPs, training materials) ensuring that they are kept current
  • Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
  • Serves as local Subject Matter Expert on relevant PV and RA regulations, processes and procedures.

The Person

The ideal candidate will:

**Thai Only** with a strong background in Regulatory & Pharmacovigilance Management ****

  • Bachelor's degree or higher in health, life science, or medical science
  • 5 + Years in pharmacovigilance and/or regulatory affairs role within Pharmaceutical Industry
  • Strong analytical, coordination, and communication skills
  • Must be fluent English

KEYWORDS: PHARMACEUTICAL, LIFE SCIENCES, MEDICAL, HEALTH, RESEARCH AND DEVELOPMENT, PROJECT MANAGEMENT, REGULATORY AFFAIRS, PHARMACOVIGILANCE

Argyll Scott Asia is acting as an Employment Agency in relation to this vacancy.