Specialists in Pharma, Clinical & IT Recruitment

Pharmacovigilance Manager/Senior Associate

Reference:
PVGMAN
Job Type(s):
PVG / Drug Safety
Salary:
Salary negotiable
Benefits:
Excellent Benefits
Town/City:
Berkshire
Contract Type:
Permanent
Date Posted:
08/01/2014 11:40:00
Start Date:
08/01/2014
End Date:
12/03/2014

Description

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.

The Role:

·         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.

Key Responsibilities:

·         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.

Skills/Experience Required:

  • 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

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