Health Sciences Authority

Senior/Regulatory Specialist, Vigilance & Compliance Branch

Fixed TermsClosed

What the role is

We are looking for a highly motivated individual with a strong desire to protect public health and safety to join us as Senior/Regulatory Specialist for post-market vigilance.

The ideal candidate will evaluate adverse event (AE) reports for locally marketed health products and monitor trends and patterns within the national AE database to identify potential safety signals. He/She will also conduct thorough reviews of various data sources including local AE reports, global safety data, scientific literature and real-world data to detect and validate emerging safety concerns. He/She will then recommend evidence-based regulatory actions and risk mitigation strategies and ensure timely communication of safety information to relevant stakeholders to safeguard public health.

What you will be working on

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
Conduct benefit-risk assessment in response to safety issues detected through routine signal reviews to ensure the balance of benefit-risk remains favourable
Perform active surveillance and signal detection/validation for drug safety signals through analysis of large electronic medical record databases
Communicate local AE information to relevant stakeholders
Contribute to the development of an IT system for data collection and analysis of AE reports for signal detection
Collaborate with international regulatory counterparts in matters relating to pharmacovigilance

What we are looking for

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
Proficiency or strong aptitude in acquiring new technical skills, such as programming languages (e.g. SQL, python and R) will be an added advantage
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

Shortlisted candidates would be contacted within 30 days from the closing date of the advertisement. We regret that only shortlisted candidates would be notified.

About your application process

If you do not hear from us within 4 weeks of the job ad closing date, we seek your understanding that it is likely that we are not moving forward with your application for this role. We thank you for your interest and would like to assure you that this does not affect your other job applications with the Public Service. We encourage you to explore and apply for other roles within Health Sciences Authority or the wider Public Service.

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.

Learn more about Health Sciences Authority