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Novotech Job vacancy for Senior Drug Safety Associate
About the Role:
Brief Position Description: 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.
Minimum Qualifications & Experience:
- A minimum of 2-4 years of industry and/or clinical experience with focus on safety related areas is required.
- Knowledge of coding applications, safety databases, processes and tools 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.
- Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred.
Responsibilities:
Manage project-specific activities which may include:
- Preparation and submission of periodic safety reports such as DSUR/PSUR, per the study requirements
- Preparation of 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 including quality review to ensure accuracy and completeness, filing study documents in TMF.
- Manages unblinding procedures, where applicable, including creation of clear SOP; integration with information technology to ensure effective implementation of the unblinding SOP across safety database and IT systems.
- Monitoring of the safety mailbox.
- Conducting literature searches and monitor for adverse event reports as well as monitor post approval commitments.
- Participate in clinical study reconciliation activities, as requested by client.
- Liaison 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; Act as key contact or point of expertise for team members and external contacts for designated projects/processes; Takes lead in updating country reference manual; Act as a subject matter expert.
- Support PV management in PV implementation activities.
