Senior/Regulatory Specialist, Vigilance & Compliance Branch
Provide up‐to‐date and unbiased information on safety issues of health products to healthcare professionals, members of the public, industry and public officers in order to enhance the safe use of health products and safeguard public health. Evaluate and review adverse event reports of locally
marketed health products, detect potential safety signals/issues and recommend appropriate regulatory actions to minimize risk, so as to ensure their benefits outweigh risks.
Evaluate and review adverse event reports of locally marketed health products, detect potential safety signals/issues and recommend appropriate regulatory actions to minimize risk, so as to ensure their benefits outweigh risks.
[What you will be working on]
1. Ensure appropriate risk communications processes to
healthcare professionals (e.g. Dear Healthcare
Professional Letters)
2. Draft communication pieces issued to healthcare
professionals
3. Preparation of Press Releases to alert members of the
public on safety issues
4. Provide inputs to media queries related to safety of
health products
5. Contribute to the publication of the HSA ADR News
bulletin and other HPRG publications.
6. Ensure smooth running of an effective and responsive
pharmacovigilance framework for the management of
adverse event (AE) reports associated with health
products
7. Perform clinical evaluation of local AE reports
submitted to HSA’s national AE database, and review
AE trends on a routine basis to closely monitor the
safety of health products, and detect any potential
safety issues
8. Conduct benefit‐risk assessment in response to safety
issues detected through routine signal reviews to
ensure the balance of benefit‐risk remains favourable
9. Communicate relevant local AE information to various
stakeholders
10. Participate in active surveillance using electronic
medical records to detect drug safety issues
11. Collaborate with international regulatory
counterparts in matters relating to pharmacovigilance
12. Contribute to the process development of IT system
for data collection and analysis of AE reports for signal
detection including data mining
[What we are looking for]
- Relevant Background in pharmacy or pharmaceutical sciences.
- At least 3 years of relevant working experience in pharmacy practice (In hospital, polyclinic or retail pharmacy) or regulatory affairs in a pharmaceutical company
- Strong knowledge in clinical pharmacy practice and drug information
- Strong analytical and communication (both written and verbal) skills
- Good understanding of pharmaceutical laws and current regulatory landscape and developments in health products (preferred)
- Able to work both independently and as a team
- Highly motivated with strong desire to protect public health and safety
- Experience with the development and use of AI chatbots, familiarity to, or willingness to learn, programming languages such as SQL and R will be an added advantage