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
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Maintain expert-level knowledge of safety profiles, labeling, and global regulations
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Lead development of project-specific procedures and workflows
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Provide technical guidance to junior team members
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Prepare for and participate in audits and inspections
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Analyze metrics and drive continuous improvement
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Collaborate with cross-functional teams on safety deliverables
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Identify risks and recommend mitigation strategies
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Ensure compliant documentation and archiving
Knowledge and Experience:
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Minimum experience of 5 years in below aspects:
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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.
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Directly Associated with the PLM and PMS/PUI activities related to CAPs and non- CAPS for EMA deliverables like eAF, ESMP.
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Has good hands on experience in Veeva Vault RIM xEVMPD and PMS UI submissions.
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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)
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Knowledge of Microsoft 365 Apps (e.g., Excel, Teams, SharePoint, etc.)
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Ability to collect, aggregate and map data from and between different documents and systems.
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