Pharmacovigilance Compliance Manager - client dedicated
- Experience Level
At PRA we’re optimistic that, individually and collectively, we can help make tomorrow better than today. We believe that it is our obligation as a company to help our people find meaningful ways to respond to the needs of others around the world. This sense of common purpose pervades our culture and serves as the foundation of who we are. Explore our career opportunities today and find out how you can be part of it.
As a PV Compliance Manager, you will be dedicated to one of our pharmaceutical clients with a truly global presence; this unique industry-changing partnership redefines collaboration. The program is ideal for individuals who thrive in a continually-evolving culture that mirrors PRA’s commitment to career development.
Working as part of our global Compliance group, you will be responsible for managing compliance activities in support of the strategic vision of the global PV Compliance function.
Your key responsibilities will include to:
- Prepare data, interpret and perform impact analysis regarding metrics for case processing and aggregate safety reporting (including regulatory expedited and periodic reporting to regulatory authorities and distribution to LOCs and business partners)
- Manage the investigation of non-compliance and implementation of corrective measures where required
- Develop and distribute regular reports regarding global compliance activities to key stakeholders
Additionally, you will also respond to requests for compliance data for audits and inspections to ensure PV regulatory inspection or internal audit readiness, and address findings as needed. Additionally you will be involved in the management of corrective and preventative action plans (CAPAs) including assessment of root cause and establishment of timeframes for process improvement.
Location: The role can be based remote in the United Kingdom, the Czech Republic, Romania, Bulgaria or Spain.
Methodical, able to effectively manage your time, and confident
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
- Previous experience in PV case processing
- Demonstrable experience using global safety databases, ideally Argus
- At least an undergraduate degree in a life-sciences discipline
- Strong Excel skills
- A common-sense and methodical approach to your work
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.