Senior Associate Pharmacovigilance Systems

Hobson Prior are looking for Senior Associate (Pharmacovigilance Systems) to join a world-wide pharmaceutical organisation on a permanent basis in Maidenhead. Our client specialises in developing novel vaccines to tackle pandemic threats and diseases all over the world.

Job Responsibilities:

• Accountable to ensure that the day-to-day operating of the Safety database and associated systems is in full Compliance with all applicable PV legislations.
• You will ensure that the PV systems are fully validated, including any validated changes over time, and that this validation is documented, and that the documentation is available on request.
• Ensure that any changes in worldwide PV legislation with implications for the safety database and/or related systems are proactively addressed by new systems and/or upgrades to existing systems in good time so that there is no loss of compliance and business continuity is maintained.
• Represent as the primary source of subject-matter expertise to address any questions from staff, external partners or from regulatory authorities regarding the global safety database and associated systems.
• Ensure appropriate training of relevant internal and vendor staff for the global safety database and associated systems, as applicable.
• For all audits and inspections, serve as the Safety System expert for the global safety database and associated systems.
• Keep alert to opportunities to promote examples of best practice across the multiple users of these systems, and working with the vendors as needed, ensure that these opportunities are implemented.
• Ensure a strategic relationship and strong communication with European, Australian R&D business partners to form a deep understanding of priorities, capability needs and desired business outcomes.
• Maintain a solid understanding of the external landscape of upcoming International regulations, new technologies and vendors supporting R&D Life Sciences processes.
• Contribute to toward the Development of PV Systems roadmap and annual detailed delivery plan, support the capability needs.

Key Skills:

• Ability to quickly analyse complex system issues and be able to guide the Business process teams internal or external and provide confirmed resolutions on how they can proceed and track the issue to closure.
• To be able to provide helpful in-depth analysis to any complex issues Data issues.
• Can validate or QC the line listings generated by the Business team for its accuracy.

Requirements:

• Bachelors/Master's in Computer Science or master's in computer applications or any other equivalent Computer science/degree.
• Previous experience with Safety System and/or has worked with in GxP environments managing and supporting tools, processes and teams.
• Experience with any Safety Systems ARISg or Oracle Argus or any bespoke Safety systems.
• Experience with any reporting tools like Business Objects or IBM Cognos or Tableau etc.,
• Experience with GxP systems validation and documentation.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.