Safety Data Professional

About the Role:

A position for Safety Data Professional is now open in Lundbeck's Global Patient Safety, Operations Singapore (GPS Operations SG).

GPS Operations SG plays a vital role within Global Patient Safety, ensuring the safety of Lundbeck products through robust global pharmacovigilance compliance. We are a team of pharmacovigilance professionals with backgrounds in medicine, pharmacy, and nursing. Our work focuses on drug adverse event processing and medical review to ensure the safety of patients using our clinical trial and marketed products.

This is a one-year contract position based in Singapore.

Responsibilities:

• Review and interpret safety information sources to assess case validity, suspect drugs, adverse events, special scenarios, seriousness, causality, and submission timelines, ensuring cases are processed accurately based on these assessments.
• Perform adverse event case processing activities in the safety database with precision and efficiency, adhering to global regulations and Lundbeck processes.
• Conduct medical coding of adverse events and products using MedDRA, company drug dictionaries, and WHO Drug dictionaries to ensure accuracy and regulatory compliance.
• Perform data quality reviews of processed cases to ensure accuracy, consistency, and compliance with regulatory standards.
• Conduct medical assessments of cases in alignment with Lundbeck processes, ensuring adherence to company standards and regulatory guidelines.
• Submit processed cases to relevant stakeholders while maintaining compliance with regulatory requirements.
• Collaborate with internal teams and external stakeholders to support safety data collection and reconciliation efforts.
• Stay informed about corporate and global pharmacovigilance regulations to ensure ongoing compliance.
• Occasional travel may be required.

Education & Qualifications

• Diploma or Degree in Biological Science, Pharmacy, Nursing, or a related field.

Skills & Experience

• Basic knowledge of pharmacovigilance, pharmacology, and the pharmaceutical industry is essential.
• Experience in drug adverse event reporting, with familiarity in safety databases such as ARISg or ARGUS being an advantage.
• Proficient in IT systems and databases, with strong skills in MS Office applications.
• Excellent attention to detail and ability to work under tight timelines.
• Strong interpersonal and communication skills to collaborate effectively with internal and external stakeholders.
• Self-motivated, a good team player, and capable of working independently.

Why Join Us

• Be part of a dynamic team of pharmacovigilance professionals with medical, pharmaceutical, and nursing expertise.
• Contribute to global patient safety and safeguarding public health.
• Work in a collaborative and innovative environment that values excellence and professional growth.

Ready to Apply

• If you are passionate about patient safety and meet the qualifications, we encourage you to join us in making a difference in the lives of patients worldwide.
• Get started by clicking Apply Now to Lundbeck Singapore Pte. Ltd.
• Only shortlisted candidates will be notified.