Job Description

An exciting opportunity with a global pharmaceutical company driving advancements through scientific research in areas of need and has strong portfolios of products across multiple therapeutic areas s An exciting opportunity with a global pharmaceutical company driving advancements through scientific research in areas of need and has strong portfolios of products across multiple therapeutic areas such as oncology, immunology and cardiovascular diseases. They are currently seeking a Senior Patient Safety Executive to join their pharmacovigilance team. The successful incumbent will be tasked to perform and contribute to pharmacovigilance activities such as individual case safety report and aggregate safety monitoring, AE reporting, risk-benefit assessment, risk management planning and strategy, and execution of post-marketing commitments while ensuring compliance with global regulatory requirements. Main Responsibilites Risk management plans submissions including additional risk minimization materials to relevant health authorities Post-marketing adverse events processing including collection, follow-up and submissions to local health authories and ethic committees of post-marketing AE from spontaneous, literature or solicited sources as applicable PV audit handling and ensuring inspection readiness Cultivate and maintain PV awareness and performing necessary PV trainings Maintenance of local market safety data quality Provide safety information and updates on emerging pharmacovigilance or patient safety issues Ensure compliance and adherence to Pharmacovigilance Agreements Requirements Relevant Bachelor Degree (e.g. life science, pharmacy, nursing) At least 2 years' PV experience in the pharmaceutical industry Experience with risk management plans and additional risk minimization materials preferred Strong organizational, faciliation and interpersonal skills to work cross-functionally with internal and external stakeholders while ensuring adherence to strict deadlines Ability to review safety information meticulously and capable of effective problem-solving Fluent knowledge in relevant standards and legislations with regards to PV (e.g. ICH, CIOMS) Next Steps Interested applicants may apply directly with your most recent CV in word format and we shall get in touch shortly for a confidential discussion on this exciting opportunity. Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502