Posted:2 weeks ago|
Platform:
Work from Office
Full Time
1. Prepare and review regulatory documents including clinical/non-clinical modules, SmPCs, PSURs, and PIs.
2. Author medical writing deliverables for drug products and medical devices across submission phases.
3. Assess adverse drug reactions and support signal evaluation.
4. Coordinate with PV vendors, manage project communications, and support audits.
5. Maintain CPD, project guides, and oversee safety agreement documentation.
Handle SOPs, trackers, reconciliation, training, and respond to medical queries.
Sentiss Pharma
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