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.