- Experience Level
- Experienced (non-manager)
As a Safety Scientist, you will provide internal and external project teams with expert knowledge on safety surveillance for medicinal products, risk management, and medical coding questions. Also, you will support or initiate process and system development or improvement activities.
Key responsibilities include:
- Facilitating specialized Safety & Risk Management services, such as generating aggregate safety reports, dRMP/RMP, and Literature Search and Review Algorithms, and their associated plans
- Performing quality control activities like review of draft planning documents (i.e., Safety & Medical Management Plans, SAE/AE Reconciliation Plans) and review of Coding Consistency listings
- Developing and delivering training courses on Safety & Risk Management related topics to PRA employees within and outside Safety & Risk Management, as well as to external parties (i.e., investigators, clients)
- Coordinating benefit risk evaluation activities, such as drafting required plans and documenting benefit risk evaluation activities
- Coordinating and leading planning and conduct of adjudication services
- Coordinating and leading all aspects of literature search and review for routing pharmacovigilance or aggregate product safety analysis
- Displaying an industry presence by writing articles for industry publications and giving presentations at industry conferences
A strong communicator, detail orientated and analytical mind.
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:
- Undergraduate degree in clinical, science, or health-related field from an accredited institution, or equivalent work experience required
- Substantial clinical research or post-marketing safety surveillance experience required, with a minimum of 5-7 years experience in pharmacovigilance
- Experience in leading professional staff in a safety surveillance, risk management and medical coding environment required with proven ability to oversee, mentor and effectively manage co-workers
- Proven history of successful involvement driving a global initiative
- Skills with industry standard safety or clinical data bases
- Good written, oral communication and presentation skills
- Read, write and speak fluent English; fluent in host country language require
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.
For more information please visit our website: www.prahs.com