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Pharmacovigilance Expert - FTC 6-12M

Pharmacovigilance Expert - FTC 6-12M

Luminary GroupCN
19 days ago
Job type
  • Remote
Job description

Luminary Group is currently seeking a skilled and experienced Pharmacovigilance Expert to join our team on a fixed-term contract basis for 6-12 months. As a Pharmacovigilance Expert, you will be responsible for overseeing and managing the pharmacovigilance activities for our client's pharmaceutical products.

Responsibilities :

  • Develop and maintain pharmacovigilance system master files and standard operating procedures.
  • Manage the collection, processing, and evaluation of adverse event reports.
  • Lead the review and preparation of periodic safety reports.
  • Conduct signal detection and analysis to identify potential safety concerns.
  • Work closely with cross-functional teams to ensure compliance with pharmacovigilance regulations and guidelines.
  • Provide guidance and training to team members on pharmacovigilance processes.
  • Collaborate with regulatory authorities during inspections and audits.
  • Stay up-to-date with the latest pharmacovigilance regulations and best practices.
  • Contribute to process improvement initiatives and implementation of new pharmacovigilance systems.

Requirements

  • Bachelor's or Master's degree in Pharmacy, Life Sciences, or equivalent.
  • Minimum of 5 years of experience in pharmacovigilance, with significant experience in managing pharmacovigilance activities for pharmaceutical products.
  • Strong knowledge of pharmacovigilance regulations and guidelines.
  • Experience in preparing and reviewing periodic safety reports.
  • Excellent understanding of signal detection and analysis methodologies.
  • Proficiency in using pharmacovigilance databases and safety reporting systems.
  • Ability to lead and manage a team and provide guidance to junior members.
  • Excellent attention to detail and strong analytical skills.
  • Excellent communication and interpersonal skills to effectively work with cross-functional teams and regulatory authorities.
  • Experience in inspections and audits by regulatory authorities is desirable.
  • Knowledge of European pharmacovigilance regulations (e.g., EudraVigilance) is preferred.
  • Strong project management skills and ability to handle multiple priorities.