Safety Physician

1 week ago

Singapore LUNDBECK SINGAPORE PTE. LTD. Full time

A position as Safety Physician is open in the Global Patient Safety (GPS) Singapore. Global Medical Safety SG is an integral part of Lundbeck Global Patient Safety department contributing greatly to achieving good Pharmacovigilance compliance in the region and globally. We are a team of 9 dynamic medical doctors performing medical safety tasks to ensure the safety of patients taking Lundbeck's drug.

It is a **12 months contract position **based in Singapore reporting to Director, Head of Global Medical Safety Established Products SG.

**Responsibilities**

Responsible for the medical review of individual case safety reports (ICSRs) for all products. Accountable for medical evaluation/interpretation of individual safety reports and aggregate safety data of products assigned including signal detection and evaluation, regulatory safety reports (PSUR, DSUR, PBRER), and ad hoc safety review/assessments.

Expected to timely communicate potential safety signals to line management. Adhere to relevant Lundbeck corporate and Global Pharmacovigilance Standard Operating Procedures and Working Instructions. Perform good quality and timely handling of single case reports (incl. medical review, qualified follow-up in ARISg Pharmacovigilance Database).

At the same time, keeping up-to-date on and communicating information from various sources in pharmacovigilance and the therapeutic areas. Contribute to knowledge and information-sharing within/across Therapeutic Groups and Global Pharmacovigilance. Participate in relevant cross-functional/organisational projects Participate in the preparation, review, and maintenance of Global Pharmacovigilance Standard Operating Procedures, Working Instructions, and Templates.

Some travelling may be required.

We offer you the opportunity to work in a global environment with exciting activities and tasks to complement and challenge you.

**Requirements**:

- Medical degree with 6-8 years of pharmaceutical industry experience is required. However, a combination of experience and/or education will be taken into consideration.
- Working experience in Pharmacovigiliance, strong clinical background/specialisation in Neurology/Psychiatry therapeutic area will be an added advantage.
- Familiarity with electronic safety databases (ARISg, ARGUS), coding dictionaries (MedDRA, DS Navigator, Medidata Coder) is preferred.
- Meticulous at work, self-motivated, good interpersonal skills
- Good team player, and at the same time able to work independently
- Excellent in communication with solid time management skills
- Good drug information research skills and the ability to conduct online research
- Proficient in Microsoft Office/computer

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