Job Description
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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.