Senior/Regulatory Specialist, Vigilance & Compliance Branch

Health Sciences Authority

Fixed TermsClosed

What the role is

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

About Health Sciences Authority

The Health Sciences Authority (HSA) applies medical, pharmaceutical and scientific expertise through its three professional groups, Health Products Regulation, Blood Services and Applied Sciences, to protect and advance national health and safety. HSA is a multidisciplinary authority. It serves as the national regulator for health products, ensuring they are wisely regulated to meet standards of safety, quality and efficacy. As the national blood service, it is responsible for providing a safe and adequate blood supply. It also applies specialised scientific, forensic, investigative and analytical capabilities in serving the administration of justice. For more details, visit http://www.hsa.gov.sg/. For more updates on public health and safety matters, follow us on Twitter at www.twitter.com/HSAsg and LinkedIn at https://sg.linkedin.com/company/health-sciences-authority.