Gbu Icsr Medical Oversight

2 weeks ago


Remote, India IQVIA Full time

**Major duties and responsibilities as per SMP**:
Oversees the Medical Review (MR) of ICSRs as per predefined activity and job-role in PV safety database, with special focus on case medical accuracy and documentation, - Maintains overall accountability for the timeliness and quality of medical case management activities outsourced to service providers, - Leads or participates in cross-functional projects or initiatives within Global Pharmacovigilance collaborates with the GSO in the review of Clinical trial and post-marketing program documentation and on labeling activities, - Establishes strong collaboration with cross-functional groups within and outside the company (i.e Business Partners, CRO), - Is the SME during internal / partner audits and inspections

**Daily activities additional details**:

- Medical review oversight of cases
- Adverse Event Dedicated Review (AEDR) of listings from ongoing clinical trials
- Case query resolutions for vendors and Global Safety Officers (GSOs)
- Communication and query resolution for clinical team members
- Raising study/product configurations requests in PV-AEGIS, as required
- Providing Safety data outputs for Clinical trials meetings
- Ensuring oversight on labelling and Reference Safety Information (RSIs) activities and communication
- Audit/Inspection support, contribution to health authority responses etc.
- Meetings with Clinical study groups, Case Management Groups, GSOs, GBU Managers etc.
- Any other ad-hoc activities/projects as required
- Relevant contributions and review in Clinical trials documents. For e.g.
- eCRF relevant sections
- SAGA Setup Specifications
- Centralized Monitoring Plan etc.



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