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Pharmacovigilance Project Manager - Drug Safety Coordinator

Pharmacovigilance Project Manager (Drug Safety Coordinator)
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As part of our Pharmacovigilance & Safety Services Department, our PV Project Manager?s act as the lead for our clients in coordinating the safety services offered by ICON. You will contribute to our culture of process improvement, oversee case processing and safety review services, and liaise with Sponsors, ICON project managers and business partners as required.
Purpose of the Role
As a PV Project Manager at the level of Drug Safety Coordinator, you will be expected to lead the safety services for a number of medium to large sized clients with the support of an assigned project director.
Work in a matrix environment to oversee and supervise employees working on deliverables for your assigned clients, including case processing, medical review, and safety reporting.
Generate metrics and status reports for clients and monitor upcoming deliverables
Present at audits for your assigned clients and internal PV audits
Undertake Root Cause Analysis (RCA) and formulate Corrective And Preventative Actions (CAPAs) if issue arise
Serve as a resource for clients and ICON personnel on safety-related issues.
Assist with generation of study specific procedures and with identifying out of scope activities in conjunction with the PVSS Project Director.
As the Drug Safety Coordinator role is our most senior, non-manager, level within the PV department then you will also have the opportunity to get involved in various non-client related activities to further development your PV skills. Examples include; process improvement initiatives, system upgrades, costings/proposals, impact assessments for regulation changes, development of PV training, process ownership.
Role Requirements
The successful candidate will have relevant clinical research/pharmaceutical industry experience in pharmacovigilance/drug safety, with knowledge of medical terminology
Must be fluent in written and verbal English with good communication skills and basic computer skills. Detail orientated and capable of working effectively within a team environment.
Medical/science background and/or bachelor?s degree or local equivalent.
Previous experience of leading Pharmacovigilance projects/studies essential
Benefits
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
What?s Next?
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

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