Senior/ Regulatory Specialist, Vigilance and

7 days ago


Singapore Health Sciences Authority Full time

**What the role is**
- Work Location: Helios, 11 Biopolis Way, Singapore 138667 Summary: - Evaluate and review adverse event (AE) reports of locally marketed health products submitted by healthcare professionals and pharmaceutical companies to HSA in order to detect potential drug safety signals and safety issues related to health products. - Recommend appropriate follow up and/or regulatory actions to minimize risk and communicate such safety information to relevant stakeholders. - Support HSA’s mission to wisely regulate health products and safeguard public health by adopting a targeted and prompt approach. Work Location: Helios, 11 Biopolis Way, Singapore 138667 Summary: - Evaluate and review adverse event (AE) reports of locally marketed health products submitted by healthcare professionals and pharmaceutical companies to HSA in order to detect potential drug safety signals and safety issues related to health products. - Recommend appropriate follow up and/or regulatory actions to minimize risk and communicate such safety information to relevant stakeholders. - Support HSA’s mission to wisely regulate health products and safeguard public health by adopting a targeted and prompt approach. Responsibilities - Ensure smooth running of an effective and responsive pharmacovigilance framework for the management of adverse event (AE) reports associated with health products - 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 - Communicate relevant local AE information to various stakeholders - Participate in active surveillance using electronic medical records to detect drug safety issues - Collaborate with international regulatory counterparts in matters relating to pharmacovigilance - Contribute to the process development of IT system for data collection and analysis of AE reports for signal detection including data mining Requirements - Possess knowledge and experience in related scientific disciplines, e.g., pharmacy, pharmaceutical sciences - Minimum 3 - 5 years of relevant clinical experience in in hospital - Strong knowledge in clinical pharmacy practice and drug information - Good communication and interpersonal skills Able to work both independently and as a team - Highly motivated with strong desire to protect public health and safety - Familiarity to, or willingness to learn, programming languages such as SQL and R will be an added advantage

**What you will be working on**

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