
Gbu Icsr Medical Oversight
2 weeks ago
**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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Gbu Icsr Medical Oversight
2 weeks ago
Remote, India IQVIA Full timeOversees 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...
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Assoc Medical Safety Dir
2 weeks ago
Remote, India IQVIA Full timeJob Overview Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety’s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors. Essential Functions -...
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Assoc Dir, Medical Safety
2 weeks ago
Remote, India IQVIA Full time ₹ 1,50,00,000 - ₹ 2,00,00,000 per yearJob Overview Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety's involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors. Essential Functions ...
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Medical Advisor – VAF
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Clinical Trial Operations Specialist
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