Roles and Responsibilities
- Perform safety signal detection and triage activities for the assigned products
- Work closely with the Pharmacovigilance Physicians (PVP) for the respective products and support them in monitoring the safety profile of products by performing post-marketing signal detection activities using internal and external spontaneous reporting databases.
- Review of technical hits in Empirica for assigned products adhering to current processes and timelines. Perform a cumulative assessment at the first-time occurrence of a hit. Focus on new cases/ Cases with significant follow-up information at re-occurrence of a hit.
- Perform signal triage and provide Empirica review results to PVPs within the assigned timeframe. Present and discuss results of post-marketing signal detection activities at Signal Management Meeting (SMM). Provide input to PV reports wherever necessary.
- Act as a core member of the SMM and support the safety leads on safety management-related topics, particularly Health Authority database (FAERS/Vigibase/Eudravigilance etc.,) related queries
- Perform database searches in external Health Authority databases (FAERS/ Vigibase), analyzing and reporting the results. Perform QC checks of Health Authority database searches done by peer members.
- Assist in providing safety input to safety documents, as well as ad hoc Health Authority queries as it relates to post-marketing signal detection activities (e.g. input from Eudravigilance data to SERM team etc.,)
- Accountable for updating Standard Operating Procedures (SOP) and Work Instructions (WI) with the current state of knowledge
- Accountable for managing terminology and product details up to date in the Empirica Signal tool (eg; Managing DME/TME details in the system
- Perform external signal detection by monitoring HA websites and/or the reference product label, and communicate the identified signals to all relevant stakeholders as per procedures. Evaluate signals from any source for their impact on patient safety and decide on actions to be taken to mitigate related risks.
- Evaluate signals originating from literature resources
- Preparation of Case Series Review (CSR) and Signal Assessment Reports (SAR)
Desired Candidate Profile
- Results and performance driven deliver results that meet or exceed expectations
- Sense of urgency – responding to issues and opportunities in a timely manner
- Intellectual curiosity – willing to suggest and try new ideas
- Positive and pro-active approach to business tasks
- Excellent interpersonal and communication skills
- A solutions provider with strong multi-tasking abilities
- Manage evolving deadlines effectively with regular feedback and updates
- Enthusiasm and Drive to take ownership and drive process initiatives