Regional Pharmacovigilance Safety Lead

CSL Vifor

Maidenhead

On-site

GBP 90,000 - 120,000

Full time

3 days ago

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Job summary

CSL Vifor seeks a senior Pharmacovigilance professional to lead cross-functional teams and ensure PV systems meet GxP and global regulations. You will mentor staff, oversee ICSR processing, and drive KPIs and CAPAs across the organization.

The role requires 5+ years in pharmacovigilance, strong regulatory knowledge, and experience with inspections. You will translate complex safety data into strategic insights for regulatory submissions.

Qualifications

Bachelor''s degree or equivalent in a life science discipline.
5+ years' Pharmacovigilance experience in multinational pharmaceutical industry.
Expert knowledge of local/international regulations and PV processes.
Knowledge of local/international relevant GxP regulations, IT standards and privacy laws.
Experience with regulatory inspections.
Experience in administration of complex data sets.
Experience in project-managing CAPA and SOP development.
Experience with relevant software applications.
Experience with GxP.

Responsibilities

Leads or plays a key role in cross-functional teams for the review of safety data or safety-related reports.
Mentors and trains newer members of the functional area.
Ensures functions to comply with national and international regulations, such as GxP guidelines and/or any other relevant national or international legislation(s).
Ensures direct reports to support and ensure QPPV’s oversight on the company’s Pharmacovigilance system.
Performs impact assessment of evolving pharmacovigilance legislations and propose or provide strategic direction for implementation of required changes to the global PV system.
Supports the preparation and conduct of PV inspections and audits, as required.
Maintain/contribute to regulatory required documents such as the PSMF.
Implements and supervise pharmacovigilance procedures and processes and ensures timely processing of safety data.
Ensure correct coding of all event and drug terms.
Develop and provide advanced analytical outputs to global teams to support analyses.
Development of new or enhancement of existing standard reports per BT quality standards.
Gathers, details, and documents user requirements for business area experts and technical team implementing the solution.
Acts as a liaison to meet regulatory reporting requirements.
Assists in the preparation of drug safety updates and other reports as necessary.
May support cross functional BT projects to fulfill GxP requirements and improve inspection readiness.