Company Overview: Our client is a global biopharmaceutical company committed to patient safety and therapeutic innovation. Their Global Patient Safety function operates regional pharmacovigilance centres that manage adverse event reporting and medical review across the product lifecycle. They are seeking a Safety Data Professional on a 1‑year contract based in Singapore.
Position: Safety Data Professional - Global Patient Safety (1‑Year Contract, Singapore)
Role summary: Provide end‑to‑end individual case safety report (ICSR) management and medical review support to ensure compliant, timely pharmacovigilance reporting. Apply clinical and pharmacology knowledge to assess case validity, seriousness, causality and regulatory reporting obligations across clinical trial and marketed products.
Key Responsibilities:
Manage full lifecycle ICSR processing: intake, assessment, medical review, coding (MedDRA/WHO Drug) and submission in line with global standards.
Analyse and interpret safety data to determine suspect drugs, adverse events, seriousness and causality.
Ensure data quality through thorough case reviews and accurate coding.
Meet regulatory reporting timelines and support submissions to internal and external stakeholders.
Collaborate with global GPS teams and other cross‑functional stakeholders to resolve case issues and ensure consistency.
Maintain safety database records and adhere to SOPs, policies and compliance requirements.
Participate in onboarding, training and continuous improvement activities occasional travel as required.
Reporting & Team:
Based in Singapore within the regional GPS Operations team works closely with global safety colleagues and clinical/regulatory partners.
Key Requirements:
Diploma or degree in a relevant discipline (e.g., Pharmacy, Nursing, Biological Science).
Basic knowledge of pharmacovigilance, pharmacology and adverse event reporting.
Prior experience with safety case processing preferred familiarity with ARISg/Argus or similar safety databases advantageous.
Proficient with IT systems and MS Office applications.
Strong attention to detail, good time management and ability to work to tight deadlines.
Effective communicator, collaborative team player and able to work independently.
Contract Details:
1‑year fixed‑term contract based in Singapore.
Occasional travel may be required.
Performance Indicators:
Timeliness and quality of ICSR processing and regulatory submissions.
Accuracy of medical coding and case documentation.
Adherence to SOPs and pharmacovigilance compliance standards.
Stakeholder responsiveness and collaboration.
What Will Make You Competitive:
Prior hands‑on experience in pharmacovigilance case processing and medical review.
Familiarity with standard safety databases and coding conventions.
Strong clinical judgment combined with meticulous data quality focus.
Apply online or contact me for further information. Only shortlisted candidates will be notified due to application volume thank you for your understanding.
Adrian Leong JAC Recruitment Pte Ltd EA Personnel: R26160017
