Pharmacovigilance Reg Submissions Specialist - Cambridge· Cambridge, United Kingdom
Pharmacovigilance Reg Submissions Specialist - Cambridge
Cambridge, United Kingdom
NEG - DOE compensation
Recruiter Comment: Drug Safety Position are Open in our Pharmacovigilance Department, please get in touch for more information.
Job Description
PPD are looking to recruit a PVG Regulatory Submission Specialist. Working within the PVG department, the PVG RSS will submit all submissions with regulatory timelines, to appropriate quality standards and following PPD procedures. The PVG RSS will also assist the Team Manager by producing study metrics (e.g. no. letters submitted for each study per month and so on) as required.
It is advantageous that the PVG RSS maintains knowledge and understanding of PPD's SOPs and WPDs; current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents and safety issues; and effectively interface with the Clinical Department, Regulatory Affairs Department, project teams and client company. The PVG RSS may also get involved in the preparation of department SOPs and WPDs. He/she also prepares for, and attends audits.
Duties Include:
- To prepare and submit expedited safety reports to applicable parties which may include regulatory agencies, ethics committees, investigators and third parties.
- To ensure these reports are submitted within the regulatory timelines to ensure compliance.
- To track all expedited safety report submissions and review compliance/produce metrics on a regular basis.
· Assist in any specific tasks, safety issues or concerns and liaise closely with Clinical, PVG, and Regulatory Affairs teams.
· To run PVG CASCADE reports and ensure bulk fax is maintained with up-to-date contact information.
· Assist in the testing of any study tracking databases and provide input into database design as required.
· Assist in archiving study files as required.
· Alert Line Manager to any quality or timeline issues.
· Provide ad hoc administrative support as and when required.
. Complete all tasks in accordance with relevant SOPs/WPDs and departmental guidelines.
· Perform any other duties as requested by Manager.
· Ensures regulatory submission files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
· Sharing of ideas and suggestions with team members ensuring effective communication within the Start-up Team.
· Facilitate and respond to company, client and regulatory audits where required.
PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations.
With offices in 45 countries and more than 11,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments.
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