safety physician in Singapore

posted
contact
jin quan jonathan soh, randstad
job type
permanent
apply now

job details

posted
location
singapore
specialism
life science
job type
permanent
working hours
Full-Time
reference number
91M0130310_1550053771
contact
jin quan jonathan soh, randstad
apply now

job description

about the company

An established Danish pharmaceutical company with fantastic work life balance and welfare


about the job

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

You are expected to timely communicate potential safety signals to line management. Adhere to relevant 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 preparation, review, and maintenance of Global Pharmacovigilance Standard Operating Procedures, Working Instructions, and Templates.

Last but not least, leading safety management for clinical development programs assigned contributing to study regulatory documents (e.g. protocol, IB, informed consent, clinical study report).


about the manager/team

A team of 5 dynamic Medical Safety professionals with medical, Pharma and nursing background performing case processing, medical review, signal detection and safety evaluation of our products to ensure safety of patients taking our drug


skills and experience required

Our preferred candidate has the following personal and professional qualifications:
Medical degree with some pharmaceutical industry experience, strong clinical background and 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.
Strong and effective communication and time management skills
Good drug information research skills and ability to conduct on-line research
Strong computer skills and a working knowledge of Microsoft Office
Meticulous at work, self-motivated
Good team player, and at the same time able to work independently


To apply online please use the 'apply' function, alternatively you may email Jonathan at jonathan.soh@ randstad.com.sg.

(EA: 94C3609/R1656945)




skills

no additional skills required

qualification

no additional qualifications required

educational requirements

Bachelor Degree