Company Overview: Our client is a mid‑sized biopharmaceutical company focused on therapies for brain disorders. Their Global Patient Safety function oversees safety surveillance for clinical and marketed products across multiple regions. They seek a Safety Physician/Scientist on a fixed‑term contract to support medical safety activities from case review to risk management.
Position: Safety Physician/Scientist - Global Medical Safety (Singapore, Contract)
Role summary: Provide medical‑scientific leadership for safety surveillance of one or more products. Responsibilities include medical review of individual case safety reports (ICSRs), signal detection and assessment, benefit‑risk evaluation, safety evidence generation, and authoring safety documents to support regulatory and risk‑minimisation activities.
Key Responsibilities:
Perform medical review and assessment of ICSRs, apply clinical judgement to seriousness, causality and case validity.
Interpret safety data analyses and contribute to benefit‑risk assessments.
Prepare and contribute to safety deliverables (e.g., PBRER/PSUR input, RMP sections, signal reports) with appropriate scientific rationale.
Lead or support signal detection, evaluation and risk‑minimisation planning.
Provide medical‑scientific input to regulatory submissions and internal safety governance (e.g., Safety Committee).
Collaborate with cross‑functional teams (pharmacovigilance, clinical development, regulatory, epidemiology) to ensure consistent safety management.
Maintain compliance with global PV regulations and Good Pharmacovigilance Practices (GVP).
Support projects and process improvements in safety surveillance and reporting.
Reporting & Team:
Based in Singapore within the Global Medical Safety team works closely with regional and global safety physicians, safety leads and cross‑functional stakeholders.
Fixed‑term / contract appointment (term length to be specified by employer).
Key Requirements:
Medical degree (e.g., MD, MBBS, BDS) or equivalent clinical qualification.
Clinical knowledge of disease states, comorbidities and treatments relevant to the therapeutic area.
Experience in pharmacovigilance or drug safety within industry, including medical review of cases and familiarity with global PV regulations and GVP.
Ability to interpret clinical and safety data and write clear scientific reports.
Strong communication and teamwork skills ability to engage cross‑functional stakeholders.
Project management capability and attention to regulatory timelines.
Preferred Background:
Prior industry experience in pharmacovigilance, safety science or safety physician roles.
Experience with safety databases and safety document authoring (PBRER/PSUR, RMP, signal management).
Therapeutic knowledge relevant to neurology/psychiatry advantageous.
Performance Indicators:
Quality and timeliness of medical review and regulatory submissions.
Contribution to signal detection and risk‑minimisation activities with demonstrable impact.
Accuracy and clarity of safety reports and committee inputs.
Effective collaboration with cross‑functional teams and adherence to PV compliance standards.
What Will Make You Competitive:
Demonstrated industry PV experience with strong clinical judgement and scientific writing skills.
Track record in signal management, benefit‑risk assessment and preparing regulatory safety documents.
Effective project management and ability to operate independently within a global safety function.
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
