Medical Safety Expert (MRQC)

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Irfa******

  • India 
  • Last Update: 29.05.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
6 Month +
Place
Hyderabad
Country
India

Category


Regulatory, Quality and Clinical

Description


Job description

Job Description

  • Provide support to a TAs according to the needs for delivery activities, i.e. ICSR medical review co- authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries. 2. Assist the GPSLs in monitoring the safety profile of products including with activities such as literature review, medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects or signal detection. Medical review of single case reports will be performed by associates possessing medical degree. 3. Perform Literature review for PSUR inclusion and assessment of literature for ICSRs. 4. Provide support for the preparation of ad hoc Health Authority queries for TAs, provide input into responses to inquiries from health care professionals on safety issues 5. Together with the Safety Leads, co-author the PSUR sections, including analytical input to PSUR for identified and potential risks defined in the Risk Management Plan (RMP) and new safety signals. Perform follow up activities on Health Authority Assessment Reports. 6. Assist in providing safety input to Regulatory Affairs and clinical documents (for CDS and IB RSI), support maintenance and management of local deviations (SMPC, USPI, Japanese PI). 7. Assist in evaluating and writing other safety deliverables including but not limited to Clinical Overview, Development Safety Profiling Plan (d-SPP), and Development Safety Update Report (DSUR). 8. Provide safety input (Addendum to Clinical Overview) for license renewal documents. 9. Provide support as needed for new indication submission (regulatory document safety input). 10. Co-author medical assessment of product quality issues. 11. Assist in the preparation of Product Guidance Documents (PGDs) for marketed products. 12. Contribute to the development and update of RMPs in collaboration with PVL/GPSL, coordination with other functions. 13. Prepare responses to internal safety requests and contribute to responses to external safety queries. 14. Act as Subject Matter Expert (SME) for Medical Safety Expert office/Medical Operations/ Medical Function (participation in initiatives).

Minimum Requirements

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