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Pharmacovigilance Manager

  • Location: Bangkok
  • Salary: THB180000 - THB220000.00 per month per month
  • Job Type:Permanent

Posted about 2 months ago

Job Description:

We are seeking a seasoned Pharmacovigilance Manager with a minimum of 7 years of experience to join our growing team. The ideal candidate will have a strong background in pharmacovigilance operations, regulatory compliance, and risk management. As a key member of our Pharmacovigilance team, you will play a crucial role in ensuring the safety and efficacy of our products throughout their lifecycle.

Responsibilities:

  • Oversee the day-to-day pharmacovigilance activities, including case processing, signal detection, risk management, and regulatory reporting.
  • Develop and maintain pharmacovigilance processes and procedures in compliance with global regulations and guidelines.
  • Serve as the primary point of contact for pharmacovigilance-related inquiries from regulatory agencies, healthcare professionals, and internal stakeholders.
  • Conduct thorough assessments of adverse event reports, including causality assessment and medical review, to ensure accurate and timely reporting.
  • Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Medical Affairs, and Quality Assurance teams to integrate pharmacovigilance activities into product development and lifecycle management.
  • Lead pharmacovigilance audits and inspections, ensuring adherence to regulatory requirements and industry best practices.
  • Stay abreast of emerging pharmacovigilance trends, regulations, and guidelines to inform decision-making and enhance pharmacovigilance practices.

Qualifications:

  • Bachelor's degree in pharmacy, life sciences, or a related field; advanced degree preferred.
  • Minimum of 7 years of experience in pharmacovigilance, with demonstrated expertise in drug safety and risk management.
  • In-depth knowledge of global pharmacovigilance regulations, including but not limited to FDA, EMA, and ICH guidelines.
  • Strong analytical skills and attention to detail, with the ability to critically evaluate scientific and clinical data.
  • Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.
  • Proven track record of managing pharmacovigilance activities independently and as part of a cross-functional team.
  • Experience working in a startup or fast-paced environment is preferred.
  • Proficiency in English is required; additional language skills are a plus.

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