Job Description

About the role

The Drug Safety Associate is responsible for complete and accurate case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations

Responsibilities:

Preparation of a safety management plan, preparing safety DB configuration documents for each project; preparing slides for project kick off meetings. Case processing activities and drafting safety narratives, monitoring of safety mailbox, filing study documents in TMF. Manage unblinding procedures. Conduct literature searches and monitor for adverse event reports as well as monitor post approval commitments. Participate in clinical study reconciliation activities, as requested by the client. Liaise with medical monitors/drug safety physicians, clients, and study teams as appropriate to clarify information required for case processing. 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. Provision of on-the-job training and mentoring of junior staff.

Experience and Qualifications:

Registered nurse/pharmacist or with health/biomedical degree or other related scientific degree/qualification is required. 2 years to 4 years of pharmaceutical/CRO experience with focus on safety related areas in clinical trial is required. Experience in coding medical terminologies, case processing, safety report submission is preferred. Thorough knowledge of medical terminology and ability to summarise medical information is required. Strong computer proficiency and ability to work in specific databases is required/preferred. Ability to follow guidelines and procedural documents is required. Experience of working with SOPs etc. is required. Fluent in both written and oral English. Good interpersonal skills 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 talking to you about working at Novotech.