Safety Officer/Pharmacovigilance Officer – Philippines, Malaysia or India

Job Description

Safety Officer/Pharmacovigilance Officer – Philippines, Malaysia or India Southern Star Research is a leading Australian, full service CRO headquartered in Sydney, Australia. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia, New Zealand and Asia Pacific Region. We recognise that attracting and retaining excellent staff is the key to developing a high quality CRO and providing our Customers with the best service possible. We greatly value the contributions our staff make to our clients’ projects and to the Company. Southern Star Research’s culture is focused on fostering and maintaining a positive, professional and productive work environment. Due to continued growth and a strong project pipeline, we’re looking for a talented full-time Safety Officer/Pharmacovigilance Officer to join our team in either the Philippines, Malaysia or India. If you’re interested in joining an innovative, exciting, Australian owned CRO, we’d love to talk to you. About the role Reporting to the Head of Clinical Operations, you’ll be responsible for: Ensure that all Safety Information, including SAE/SADE initial and follow-up reports, are completed and reported accurately; Act as the primary point of contact with Investigator and site personnel to resolve safety-related queries and obtain missing data; Serve as the main contact for the appointed client safety or pharmacovigilance officer, ensuring timely communication of safety data; Ensure that all SAE/SADE reports are forwarded to the client safety or pharmacovigilance officer within the defined timelines; Address safety queries and assist in preparations for data lock; Review closed cases for archiving readiness and ensure they are archived according to local filing procedures; Report SAE/SADEs to local regulatory authorities in accordance with local regulations; Maintain compliance with all applicable regulations, including CFR, ICH/GCP/ISO14155, and internal SOPs; Assist in the development of training materials and guides for sites, investigators, monitoring teams, and other junior safety staff; Write safety reporting plans and ensure staff compliance with safety reporting protocols; Track and enter safety data into tracking databases and assist in the analysis of safety queries and data quality; Mentor and assist new hires in their professional development and understanding of safety reporting procedures; Take initiative in improving processes, including Standard Operating Procedures related to safety; Lead the implementation of new Safety/PV systems as required; and Perform any additional responsibilities as assigned. Does this sound like you? To be successful in the role, we’re looking for candidates with: Minimum 2 years’ experience working in safety / pharmacovigilance / regulatory within a pharmaceutical company or CRO focused on clinical trials. CRO experience is preferred; Experience using Safety/PV database platforms. Oracle Agrus Safety is preferred; Strong understanding of APAC safety operations from a regulatory perspective, including regulatory safety reporting timelines; Ability to analyse safety information (SAE/SADE initial and follow up reports), identify and raise queries; Excellent interpersonal and communication skills (verbal & written), including proficiency in medical terminology; Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines (MSc or PhD is highly desirable). Why Southern Star Research? Southern Star Research is a growing business within the Asia Pacific region and this is an ideal opportunity for someone who is looking to contribute towards our expansion into the APAC region. Southern Star Research are also proud to be certified as a Great Place To Work in Australia! We offer: An attractive remuneration and benefits package; Genuine work-life balance (we appreciate you have hobbies, family and a personal life outside work); We value flexibility, and we welcome a discussion on what might work for you to meet your work/life commitments and support your wellbeing; Career stability and security and more! We’d love to connect with you! Don’t have all the requirements of this role, but still interested? Please still apply! Inclusivity, Diversity and Equality Our commitment is to create a safe and inclusive environment that celebrates the diversity of our employees with their diverse perspectives, backgrounds and cultures. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Please note that only successful candidates will be contacted. #J-18808-Ljbffr