Senior/Regulatory Specialist, Vigilance

3 days ago

Singapore HSA Health Sciences Authority Full time

(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.

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