High Wycombe, UK

Drug Safety Assistant

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Mon 04/12/2017

COMPANY: PE GLOBAL

JOB TYPE: Permanent

SALARY: Negotiable

Drug Safety Assistant

At PE Global we are currently seeking a Drug Safety Assistant for a Multinational Pharmaceutical client. The role is based in Buckinghamshire for a 12 month contract for 37 hours per week.

Role Purpose

To execute Drug Safety support activities as required for Marketing Authorisation Holders (MAHs) and /or study sponsor, as applicable to ensure the company complies with Good Pharmacovigilance Practice regulation.

Key Role Activities

Call handling

  • Answer inbound calls from general public, HCPs, internal colleagues to elicit and capture relevant adverse event data

Case Processing

  • Enter relevant/required safety data into the Global Safety Database from spontaneous sources.
  • Request additional information from multiple sources, both internal and external to the Company

Reconciliation

  • Confirm that requests for additional follow-up has been sent to reporters as appropriate through review of due diligence reconciliation reports and monitoring the due diligence inbox

Additional Compliance Activities

  • Review case files and/or processes as directed to support internal and external audits and inspections
  • Complete all assigned training in a timely manner
  • Support Head of Drug Safety/LSO in responding to ad hoc requests as required
  • Administers the due diligence process to ensure completeness of case reports and timely distribution of follow-up requests
  • Files maintains and archives all case materials, including original source documentation

Key Compliance Requirements
Applicable to all roles

  • Complete annual Drug Safety and HCBI Awareness training
  • Report Adverse Events and complaints in a timely way to Drug Safety according to current Adverse Event Reporting guidelines/SOP and to maintain Regulatory compliance
  • Acts in accordance with company HCC requirements if interacting with Healthcare Professionals
  • Complies with designated SOPs for the role


Qualifications

  • Degree-level qualification or equivalent nursing qualification
  • Registration with official governing bodies e.g. General Medical Council, Royal Society of Pharmacists

Essential Knowledge & Skills

  • Awareness of and familiarity with medical terminology
  • Proficiency in global and local SOPs
  • Computer literate with knowledge of the Global Safety Database
  • Ability to prioritise and work to strict timelines on a daily basis
  • Excellent verbal and written communication skills
  • Ability to work effectively as a member of the Drug Safety and broader Medical Department teams
  • Previous experience in a similar/related role is desirable
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