Senior Drug Safety Associate

My client, a leading pharmaceutical company based in Cambridge, are currently searching for an experienced Senior Drug Safety Associate to join their team on an initial 12 month contract basis.


Responsibilities


, Legislation: Maintains own current knowledge of compliance with local safety regulations.

, Case management: Performs business critical “core” safety activities per legal deadlines, including intake of AE reports, follow up with HCPs for complete data, ICSR & aggregate safety report submission to regulators.

Handling safety enquiries received to the departmental inbox from both internal and external stakeholders.

Review metrics to monitor MHRA & HPRA submission compliance.

Risk Management; Assist with submission of safety risk communications (e.g.

Dear Investigator Letter, Urgent Safety Measures, Risk Minimisation Materials etc) in conjunction with Regulatory Affairs, Clinical and Medical Departments.

, Key contact; Serves as key contact for defined safety activities within the affiliate.


, Cross-functional work; Collaborate with other affiliate departments including medical and commercial, to provide safety input into cross-functional initiatives (e.g.

Patient Support Programs).

Ensure PV compliance in these initiatives while understanding local business needs.

, Training; Delivers safety reporting training for local affiliate staff and external service providers.

, PV Review; May assist with safety review of local study protocols, market research programs and social media projects.

, Audit; Assists safety team during audits and inspections of PV operations.

, Support; Assist Global Safety Manager or Senior Global Safety Manager with provision of safety activities to support the local business; assist with issue resolution where necessary.


Experiance Required



  • Teamwork and Cooperation; the intention to work cooperatively with team members and those outside the team.

  • 3 years of PV/Drug Safety experience
    Analytical Thinking; Ability to analyse problems/issues and determine the most appropriate course of action based on that analysis within defined policies and procedures.

  • Customer Service Orientation; focusing efforts on discovering and meeting the customer or clients needs.

  • Initiative; the identification of a problem, obstacle or opportunity, and taking action.

  • Information Seeking; driven by a desire to understand and know more about people, things or issues.

  • Relationship Building; builds and maintains warm relationships with networks of people.

  • Drive for Excellence; the intention to work to high standards and personally striving to improve.

  • Graduate with life science or healthcare degree and proven relevant industry experience within pharmacovigilance.

  • Understanding of the importance of pharmacovigilance in ethical pharmaceutical marketing and development.

  • Use of MS Office products to a competent standard - Word, Excel, Powerpoint.

  • Experience with Safety Databases, particularly ARGUS, would be desirable.


  • Start: ASAP
  • Duration: 12 Months
  • Rate: £30 - £32 per hour
  • Location: Cambridge, England
  • Type: Contract
  • Industry: Pharmaceutical
  • Recruiter: Key People
  • Tel: +44 (0)1727 817 626
  • Fax: 01727 844 838
  • Email: to view click here
  • Posted: 2020-12-22 21:52:24 -

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