Pharmacovigilance Manager/Senior Associate
My Client an expanding Pharmaceutical company has opened a new vacancy within their Pharmacovigilance team. They are actively looking to recruit a Senior Pharmacovigilance Officer/Manager to their team on a permanent basis, for their offices in Berkshire.
· To support the QPPV by contributing scientific and safety expertise for regulatory reports and process/procedure design and by providing safety oversight for assigned projects and clinical trial protocols.
· To support the VP, Global Drug Safety & Pharmacovigilance (GDSP) in leading the GDSP Operations function and by contributing innovative ideas and implementation plans for further development and improvement of drug safety processes.
· Responsible for overseeing post-marketing safety reporting for all marketed products and serious adverse event reporting for all company sponsored clinical trials.
· Responsible for ensuring that Global Drug Safety operates in compliance with worldwide legal and regulatory pharmacovigilance requirements in addition to the local regulatory and pharmacovigilance requirements.
· Maintain oversight of local safety officers at affiliates/distributors and contractors.
· Apply expertise in, using worldwide PV/regulatory regulations and intelligence in the preparation and/or review of regulatory reports and other documents.
· Liaise with Commercial and Medical Affairs to identify new programs or studies that may generate adverse event reports and develop a strategy to report those events to Global Drug Safety.
· Assist in preparation for and conduct of internal and regulatory audits.
· Manage the relevant day-to-day aspects of safety agreements with relevant partners.
· Participate in continuous process improvement and maintenance of quality standards for the department.
· Propose and lead improvement initiatives as assigned.
· Assist the VP, Global Drug Safety & Pharmacovigilance in establishing goals in line with department strategies and monitoring progress against them.
· Undertake any other relevant tasks/project as and when requested by Global Drug Safety senior management.
· Develop, implement and maintain consistent working processes and SOPs pertaining to SAE processing, reporting and other drug safety activities.
- BSc/BA Degree in related discipline and/or equivalent experience
- 3-5 years’ experience in Pharmacovigilance with demonstrated track record of achievement.
- Has Experience within delivering PV Training and Writing PV SOP’s.
- Has Written PSUR’s, RMP’s and performed Signal detection.
- Fluent in English and Eligible to work in the UK.
For more information regarding this vacancy or a confidential job discussion, please get in touch with Neal Panting. Neal@arc-7.com or +441483 397070