Company: inVentiv Health Clinical
Reference: GSPVSS, UK
Closing Date: 24 Oct 16
Salary (£): Negotiable
inVentiv Health – Transforming Promising Ideas into Commercial RealityJob Title:GSPV Submission Specialist II, UKPrimary Function:As a member of our Global Safety and Pharmacovigilance team, working with colleagues across EMEA, US and India, you will be responsible for responsible for preparing and submitting expedited and annual safety reports to regulatory authorities, ethics committees and investigators; collaborating with both internal and external clients to ensure all requirements are ...
inVentiv Health – Transforming Promising Ideas into Commercial Reality
GSPV Submission Specialist II, UK
As a member of our Global Safety and Pharmacovigilance team, working with colleagues across EMEA, US and India, you will be responsible for responsible for preparing and submitting expedited and annual safety reports to regulatory authorities, ethics committees and investigators; collaborating with both internal and external clients to ensure all requirements are achieved with accuracy and according to project and regulatory timelines.
* Collaborate with the Sponsor and internal project management associates on the design, preparation, an assembly of the Expedited and Periodic Safety Report Documents
* Maintain 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 launch activities and assist with the development of the Safety Monitoring Plan
* Attend project team meetings and investigator meetings as requested
* Lead low to moderate complexity safety submission-only projects and perform project management responsibilities if required
* Participate in the development of the Safety Monitoring Plan or ESR Distribution Plan for projects requiring safety submissions
* Develop the Safety Monitoring Plan or ESR Distribution Plan for safety submissions-only projects
* Participate in project meetings as required
* Participate in the development of safety submissions related SOPs and Operating Guides
* 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
* Train other Safety Submissions Associates on processing/reporting and to other members of the GSPV group involved in safety submissions
* Assist other Safety Lead/PM for projects as applicable including representation of GSPV project team and client meetings
* Any other duties as assigned by manager
* Bachelors Degree, preferably in a life science, nursing, pharmacy and proven safety/PV experience.
* Familiarity with safety database systems: ARISg or Argus preferred
* Ability to successfully prioritize and work on multiple tasks.
* Excellent team player and attention to detail.
* Good (excellent for Subs Assoc II) 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, with an ability to inform, influence, convince, and persuade
* Ability to travel as necessary (less than 5%)
In return we will offer:
* A competitive remuneration package with excellent benefits
* A commitment to your professional development as a key member of our Senior Leadership Team
* The opportunity to work within a successful and rewarding environment.
Location: UK, home or office based
We look forward to receiving your application.
inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry deliver new drugs and therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) is made up of more than 14,000 employees who have the ability to service clients in more than 90 countries. We offer a differentiated set of solutions designed to improve client performance and accelerate the process of bringing products to market. For more information, visit inVentivHealth.com
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