Description The Pharmacovigilance (PV) Scientist 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: Manage project-specific activities which may include preparation or review of safety management plan, data management plan, case report forms (as required), preparing safety databases such as Veeva Vault Safety, ArisG, Argus and cubeSAFETY, prepare configuration documents for each project; preparing slides for project kick off meetings, provide study specific safety reporting trainings to investigators/ study team and end to end PV project management. Case processing activities and drafting safety narratives, monitoring of safety mailbox, filing study documents in trial master file (TMF). Manage site and regulatory submissions for both expedited and periodic reports (line listings and DSUR) Act as key contact or point of expertise for team members and external contacts for designated projects/ processes Participate in safety reconciliation activities, as requested by client. Liaison with medical monitors/ Pharmacovigilance physicians, clients, and study teams as appropriate to clarify information required. Participation in inspection/ audit related activities; Assistance in preparation or implementation of corrective/ preventative actions relating to case processing. Timely submission of reports to regulatory agencies in accordance with applicable regulations and tracking the details of submissions for compliance. Any other responsibilities as assigned by the line manager. Minimum Qualifications & Experience: Registered nurse/ pharmacist or with health/ biomedical degree or other related scientific degree/ qualification is required. Postgraduate qualifications or certification in clinical trials will be an advantage. 2 years to 4 years of pharmaceutical/ CRO experience with focus on safety related areas in clinical trials is required. Knowledge/experience in international drug safety-regulatory reporting obligations and compliance. Experience in coding medical terminologies using MedDRA and WHO-DD, case processing and safety report submission is preferred. Strong computer proficiency and ability to work in specific databases is required/ preferred. Ability to follow guidelines and procedural documents is required. Fluent in both written and oral English. Good interpersonal skill to professionally communicate with all levels of the organizations. Good time management & multi-tasking capability. 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.
