Senior Pharmacovigilance Associate - Korean speaking

The Pharmacovigilance Associate/ Senior/ Specialist is responsible for conducting the PV related work according to ICH-GCP, SOPs, project specific procedures, and applicable regulatory requirements.

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, 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

Minimum Qualifications & Experience:

• Bachelor of pharmacy/nursing/medicine/biology or a related major. A master/PhD degree is preferred.

• 3+ years of PV relevant experience is preferred

• Knowledge of clinical medicine is preferred.

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 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.