Senior Patient Safety Specialist
Primary Location: India, Remote ID de la oferta R0000041461 Categoría Medical Sciences
sobre este trabajo
The Senior Patient Safety Specialist provides advanced support and leadership across global pharmacovigilance activities in both clinical trial and post-marketing settings. This role contributes expert-level knowledge and oversight to safety reporting processes, ensuring compliance with international regulations and internal standards. Responsibilities include mentoring junior staff, optimizing workflows, and collaborating cross-functionally to drive quality and efficiency in safety deliverables.
Key Accountabilities:
General
- Maintain expert-level knowledge of safety profiles, labeling, and global regulations
- Lead development of project-specific procedures and workflows
- Provide technical guidance to junior team members
- Prepare for and participate in audits and inspections
- Analyze metrics and drive continuous improvement
- Collaborate with cross-functional teams on safety deliverables
- Identify risks and recommend mitigation strategies
- Ensure compliant documentation and archiving
Knowledge and Experience:
- Minimum experience of 5 years in below aspects:
- Validating and maintaining the regulatory information and performing xEVMPD submissions via EMA gateway and tracking the status of Acknowledgement received through Register/Ag-Xchange, Veeva Vault and EV Web For Authorized Medicinal Products and Development Medicinal Products.
- Directly Associated with the PLM and PMS/PUI activities related to CAPs and non- CAPS for EMA deliverables like eAF, ESMP.
- Has good hands on experience in Veeva Vault RIM xEVMPD and PMS UI submissions.
- In-depth expertise on both regulatory processes for submission of data and documents (SmPC/PILs/Health Authority Communications) for medicinal products (i.e., xEVMPD, IDMP, CTA, MAA, lifecycle management) and utilization of regulatory systems (RIMS, DMS)
- Knowledge of Microsoft 365 Apps (e.g., Excel, Teams, SharePoint, etc.)
- Ability to collect, aggregate and map data from and between different documents and systems.
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