Drug Safety Associate
- Experience Level
- Experienced (non-manager)
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 Drug Safety Associate 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.
In this role, you will be responsible for providing operational support to Global PV Operations. You will be part of a larger PV Operations Group, working within the UK Team for a Assigned Client Project:
Main responsibilities will include:
- Managing mailboxes – responding to data entry / case processing queries from vendors, Partners andLOCs, providing responses as per our client’s processes
- Working on SUSAR reporting, sending different reports regarding clinical cases
- Working on E2B format reporting and Case Finalization; reading error messages and taking steps to correct cases as a result of negative acknowledgments.
- Performing reporting to LOCs and Regulatory Authorities
- Investigating cases of non-compliance of ICSRs and providing CAPAs.
- Reviewing and Performing Literature Articles QC for AEs.
- Supporting the LOCs in PV activities related to queries and requests regarding case handling
- Communicating with alliance partners and vendors regarding the evaluation and processing of ICSRs
- Performing quality-control of case deletions in ARGUS to ensure the deletion has been managed correctly by the vendor
- Performing retrospective QC of finalization, ensuring reports have been sent to the correct vendor, LOC or Health Authority.
- Expedited Reporting activities involving Work Instruction Updates, System Reporting Rules, Regulatory Intel, Clinical Reporting Instructions Updates.
- Reviewing Partner Agreements, PVA Execution. Reconciliation Oversight for PVAs.
- Contributes to improvements of team processes.
- Assist when required in Partner, Health Authority Audits/Inspections.
Other PV operational activities or initiatives as assigned
As a PV Process Manager you will interact with senior client stakeholders, vendors and internal PV colleagues at PRA.
The role is office-based in London with flexibility to work from home on a regular basis.
Able to integrate with others and work well within a larger team, detail-orientated and confident. Able to confidently understand Pharmacovigilance Terminology and have experience with Drug Safety Databases. Able to have good communication skills and able to adapt to changes efficiently.
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:
- Strong experience in using Argus database and confidence in data entry (performing and QC)
- Previous experience working in PV and dealing with Adverse Events
- Ideally experience in E2B reporting
- Understanding of Health Authority (EMA, FDA) regulations on ISCRs
- Good vendor management skills
- Ideally an ability to read SUSAR cases in Argus
- BSc Life Sciences preferable
- Previous relevant experience within CROs, Pharmaceutical Companies or equivalent.
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.