Case Specialist – Level 2 Officer/ Senior Associate

2 weeks ago

Philippines Groupe ProductLife Full time

Philippines

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Product Development

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Safety and Vigilance

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Permanent contract

Deliver Excellence in Pharmacovigilance

Join Our Patient Safety Team as a Patient Safety Associate and assist in the day-to-day delivery of pharmacovigilance and safety-related projects, including processing safety information received by, or requiring action on behalf of clients.

About the Role

In this role, you will:

  • Act as part of the PS & RM Team in line with the scope of the project to meet project outcomes and deliverables ensuring compliance.
  • Work within the systems and processes designed to meet Good Pharmacovigilance Practices (GVP).
  • Ensure that all adverse events or product complaints associated with adverse events are appropriately reported and followed up according to client procedures.
  • Evaluate adverse event & follow-up reports received from various channels and perform the necessary assessments for validity, seriousness, causality, and expectedness.
  • Process & report safety data per internal SOPs and applicable regulatory requirements.
  • Maintain the integrity of client safety data registered into the safety databases.
  • Participate in internal and external audits.
  • Perform literature surveillance activities and regulatory authority adverse event interrogations.
  • Assist the Project Manager or the Patient Safety Manager/Senior Manager as requested (e.g., to provide input to SOPs or Safety Data Exchange Agreements).

What You Bring

  • Health Science degree or equivalent. Previous clinical experience is highly regarded.
  • Minimum 3 years of experience in a pharmacovigilance or related role in a highly regulated industry e.g., pharmaceutical or medical devices.
  • Strong working knowledge of the regulatory requirements for managing and reporting adverse events to major competent authorities in the APAC region such as the TGA (Australia), Medsafe (New Zealand), HSA (Singapore), PMDA (Japan), or MFDS (South Korea).
  • Understanding of the applicable regulatory requirements of comparable regulators outside APAC such as EMA or US-FDA.
  • Hands-on experience in using safety databases such as Argus, ARISg, Veeva Vault Safety.
  • Practical experience in writing and managing controlled documents such as Safety Data Exchange Agreements or Vigilance Agreements.
  • Experience in clinical trial pharmacovigilance is desirable.

Why Join Us?

  • Collaborate with some of the brightest minds in pharmacovigilance .
  • Contribute to projects that have real-world impact on patient care .
  • Enjoy a flexible, hybrid work model and a commitment to work-life balance.
  • Join a company that values expertise, purpose, and progress .

Ready to make a bigger impact?
Click Apply Now and help shape the future of pharmacovigilance across the Philippines and the broader JAPAC region.

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