Drug Safety Associate

7 months ago

India Novotech Asia Full time

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 1- 3years of industry and/or clinical experience with focus on safety related areas is required.
- ** Experience in Safety management plan (SMP) or risk management plan (RMP).**:

- ** Should have processed SUSAR cases.**:

- ** Should have done any ICSR unblinding.**:

- Thorough knowledge of medical terminology and ability to summaries 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 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.
- Preparation and submission of periodic safety reports such as **DSUR/PSUR**, per the study requirements.
- Support PV management in PV implementation activities.

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