The purpose of the Pharmacovigilance Associate role is to monitor and manage the safety aspects of clinical studies/post-marketing surveillance including but not limited to monitoring safety mailbox, preparation of safety management plan, setting up safety database for studies, processing & submission of ICSRs (SAE/SUSAR/AEs) in accordance with ICH-GCP, SOPs and applicable regulatory requirements/ensure compliance with regulations.
ResponsibilitiesThe Pharmacovigilance Specialist is responsible for conducting the PV related work according to ICH-GCP, SOPs, project specific procedures, and applicable regulatory requirements.
We offer hybrid working arrangements and full flexibility in working hours to ensure our staff achieve the work-life balance often missing in this role.
Responsibilities:
• Support to set up the related system and safety database such as ARGUS, ARISg and CRSCube.
• Support to set up and update the related SOPs and ensure the regulatory compliance.
• Support the PV related work in the clinical projects including but not limited to case processing, /adverse event reporting/review of annual safety report, expedite/periodic reporting of safety information to regulatory authorities/investigators/IRBs/sponsors, and the preparation of safety management plan.
• Support to perform post-marketing PV service tasks including but not limited to case handling, literature searching and reviewing, expedited / periodic reporting of safety information to regulatory authorities/sponsors in compliance with regulatory timelines.
• Support to prepare periodic aggregate reports (PSUR/PBRER/DSUR) and Risk Management Plan.
• Conduct the quality control of pharmacovigilance activities to ensure the data accuracy and completion.
Minimum Qualifications & Experience:
• Bachelor of pharmacy/nursing/medicine/biology or a related major. A master/PhD degree is preferred.
Experience in DSUR writing will be considered a strong advantage
• 2+ years Clinical /PV relevant experience is preferred for PV Associate/Specialist; and 4 years or above PV relevant experience is preferred for senior PV Associate/Specialist.
• Knowledge of clinical medicine is a must. Have strong clinical expertise and capabilities of information collection and integrations.
• Familiar with GCP and ability to quickly learn and expert local regulations, ICH related regulations and essential knowledge about therapeutic areas, pharmacovigilance, and clinical trial.
• Proficient in the use of computer software such as MS office applications.
• Understand MedDRA coding.
• Clear verbal and written communication style.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.
