Deskripsi Pekerjaan
Are you a detail-oriented professional looking for a rewarding global role in clinical project management? Thermo Fisher Scientific is seeking a dedicated PV Coordinator to join our dynamic team. In this pivotal position, you will support our Pharmacovigilance (PV) operations, ensuring the integrity of patient safety data and strict compliance with global regulatory standards. You will collaborate with cross-functional teams to process adverse event reports, manage regulatory submissions, and contribute to the continuous improvement of our pharmacovigilance processes. This is an excellent opportunity to grow your career within a world-leading scientific organization while making a real impact on global healthcare safety.
Tanggung Jawab
- Manage the end-to-end processing of Adverse Event (AE) reports in accordance with local and international regulations, including ICH-GCP and local PV laws.
- Review and validate Case Report Forms (CRFs) and adverse event narratives for accuracy, completeness, and compliance.
- Prepare and submit Periodic Safety Update Reports (PSURs) and other regulatory documents to relevant health authorities on schedule.
- Conduct trend analyses of safety data to identify potential safety signals and support ongoing risk management activities.
- Act as the primary point of contact for internal stakeholders regarding pharmacovigilance queries, clarifications, and data discrepancies.
- Maintain up-to-date knowledge of evolving regulatory guidelines and industry best practices to ensure organizational compliance.
- Assist in the maintenance of pharmacovigilance systems and databases to ensure data integrity.
Kualifikasi
- Bachelor’s degree in Pharmacy, Nursing, Biology, or a related Life Sciences field is required.
- Minimum of 2-3 years of experience in Pharmacovigilance, Clinical Research, or Regulatory Affairs is strongly preferred.
- Strong understanding of ICH guidelines (GCP, E2A, E2D) and local pharmacovigilance regulations.
- Excellent attention to detail with the ability to detect errors in complex data sets and documentation.
- Proficient in Microsoft Office Suite, particularly Excel and MS Word.
- Strong written and verbal communication skills in English are essential.
- Ability to work independently and manage multiple priorities in a fast-paced environment.