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GSPV Submissions Specialist I, UK

Job Field:
Regulatory and Drug Safety Jobs
Drug Safety Jobs, Pharmacovigilance Jobs
United Kingdom
Contract Type:
1 to 2 per annum
Salary Description:
Inventiv Health
Job Ref:


Global Safety Pharmacovigilance Submissions Specialist I, UK

UK, Maidenhead

Office based



Here at inVentiv Health Clinical we are currently recruiting for a Global Safety Pharmacovigilance Submissions Specialist I to be based in Maidenhead.

inVentiv Health: Work Here. Matters Everywhere.

Job Details:

As a member of our Global Safety and Pharmacovigilance team, working with colleagues across several countries you will be responsible for submission to Ethics Committees and Investigators.


* Collaborate with the Sponsor and internal project management associates on the design, preparation, an assembly of the Expedited and Periodic Safety Report Documents
* Assist tracking of safety submissions
* Provide Sponsor with Expedited and Periodic Safety Report submission status updates, as required
* Foster constructive and professional working relationships with all project team members, internal and external
* Provide support/advice on Expedited and Periodic Safety Reports issues to project team/Sponsor as required
* Apply safety reporting regulatory intelligence maintained by inVentiv Health Clinical to all safety reporting activities
* File documents according to project specific requirements (electronically or in hard copy as applicable)
* Forward completed safety submission confirmations to clients and other relevant parties
* Maintain knowledge of legislation, guidelines and regulatory intelligence related to safety reporting applicable to countries where inVentiv Health Clinical manages safety responsibilities
* Provide support for Safety Lead with miscellaneous project tasks related to safety reporting
* Participate in audits as required/appropriate
* Participate in project meetings as required
* Interact and communicate effectively with other company departments/functions such as project management, field monitoring, data management, etc. to ensure the highest level of client satisfaction through successful execution of projects
* Any other duties as assigned by manager


The ideal candidate will need the following experience / skills to be considered:

* Bachelors Degree, preferably in a life science, nursing, pharmacy and proven safety/PV experience.
* Ability to successfully prioritize and work on multiple tasks.
* Excellent team player and attention to detail.
* Good knowledge of ICH guidelines and regulations relating to safety reporting.
* Computer proficient including experience with Microsoft Office Suite, including but not limited to word processing software (MS Word), presentation software (MS PowerPoint), email software (Outlook), diagramming/workflow software (MS Visio) and spreadsheet software (MS Excel).
* Excellent communication, presentation, interpersonal skills, both written and spoken


* Competitive remuneration package with excellent benefits
* Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
* Opportunity to work within a successful and rewarding environment.

Application Details

To find out more about our company and search and apply for other open jobs please visit our website

inVentiv Health Clinical delivers high quality drug development programs and clinical staffing solutions of all sizes around the world to achieve our vison - Shortening the distance from lab to lifeTM

Closing Date:

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