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Manager, IT Operations

ICON Public Limited Corporation

This is an exciting opportunity to join ICON "At ICON, it's our People that set us Apart" ICON plc, a leading global Contract Research Organisation employing 14...

This is an exciting opportunity to join ICON

"At ICON, it's our People that set us Apart"

ICON plc, a leading global Contract Research Organisation employing 14,000 people in 40 countries. ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. www.iconplc.com

Position Summary :

Support Pharmacovigilance and Safety Services systems including Argus and other supporting systems in line with ICON Business Strategy and IT Governance and Control objectives.

Job Responsibilities:

* Provide Drug Safety application support

* Generate standard line listings from Argus safety database for DSURs, 6-monthly line listings, business partner exchange, PSURs/PBRERs.

* Generate Ad hoc safety data listings for internal customers

* Troubleshooting technical issues that may arise during E2B import, E2B exchange and/or global transmission of ICSRs and aggregate safety data to regulatory authorities, business partners and applicable vendors

* Provides technical/functional leadership in the Drug Safety application support function and in planning and deployment of new releases

* Collaborates closely with IT and PVSS department in setting a high standard with respect to protection of safety data systems and access.

* Triages and leads root cause analyses (RCA) for complex business issues with respect to safety systems issues and data integrity

* Maintains strong knowledge with evolving international guidance and regulations for global safety reporting, safety surveillance and risk management in both a clinical and post-marketed setting (FDA, EMA, MHRA, CFDA/SFDA, PMDA and other Asia/Pacific territories)

* Support Drug Safety & PV inspection readiness activities

* Supports PV regulatory inspection safety data requests as required

Benefits of Working in ICON:

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.

ICON is an equal opportunity employer, including disability/veteran, and committed to providing a workplace free of discrimination and harassment.

Job posted: 2020-06-20

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