Global Safety Pharmacovigilance Submissions Specialist I, UK
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.
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.
To find out more about our company and search and apply for other open jobs please visit our website http://www.inVentivHealthclinical.com
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