Company: INC Research
Location: Camberley, Edinburgh, UK Regional
Closing Date: 16 Dec 16
Salary (£): Negotiable
Do you want to be a part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development.
We are seeking a Director, Safety and Pharmacovigilance to be based in the UK in Camberley, Edinburgh or regionally based. This is a unique opportunity to shape, lead and develop the post-approval Pharmacovigilance (PVG) business offering from INC Research.
•Responsible for the design and implementation of life-cycle PVG services, including gap analysis to determine direction for INC Research in support of PVG systems.
•Special emphasis on working with clients navigating the change from clinical development into the post-approval environment
•Developing and supporting education across the INC Research organization with respect to post-approval PVG
•Collaboration with INC Research Business Development to educate, lead and develop customer relations, business development and the marketing of PVG services
•Provide an intense level of support to all aspects related to the development of a PVG life-cycle activity, collaborating with INC Consulting, Medical Writing and Late Phase services at INC
•Draft, negotiate and execute SDEAs, PSMF, and deliver subject matter expert contribution to RMP, REMS and other related activities
•Assume ownership of QMS documentation associated with post-approval PVG
Skills and attributes:
•Career expert in Safety & PVG, specifically in the post-approval environment.
•Bachelor’s degree or equivalent in a medical or science field, or equivalent education and experience.
•CRO industry experience preferred, EU QPPV experience valuable.
•Strong client relationship management skills.
•Strong understanding of PVG regulatory environment
•Extensive leadership skills managing PVG teams in a range of therapeutic areas
•Experience in winning and delivering a range of PVG projects.
•Leadership skills to provide direction to, and foster teamwork across multiple/complex projects.
•Ability to coach and develop others and to act as a catalyst for change.
•Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint) and email.
•Fluent in written and spoken English with strong verbal and written communication skills.
Why choose us:
It takes skill and passion to develop medicines the way we do. Don’t worry – if you’ve got the passion part, we’ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.
We’ve got an attitude at INC: “Can do, I own it.” Absolutely everyone has ownership of what they do here. And because we’re given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.
“INC Research has been ranked as “Top CRO to work with” among large global CROs in the biannual CenterWatch Global Investigative Site Relationship Survey. INC is the only CRO to rank consistently among the top three CROs in all seven CenterWatch site relationship surveys conducted since 2007”.
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.
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