Pharmacovigilance Project Manager - Drug Safety Coordinator
About the role
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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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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