Senior/Regulatory Specialist, Vigilance

What the role is What the role is: (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 Ensure appropriate risk communications processes to healthcare professionals (e.g. Dear Healthcare Professional Letters)Draft communication pieces issued to healthcare professionals Preparation of Press Releases to alert members of the public on safety issues Provide inputs to media queries related to safety of health products Contribute to the publication of the HSA ADR News bulletin and other HPRG publications. 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 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 more updates on public health and safety matters, follow us on Twitter at and LinkedIn at #J-18808-Ljbffr