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Drug Safety Scientist

  • Job reference: 921003
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: R&D - Clinical & Non Clinical, Life Sciences
  • Date posted: 04/08/2018

OrionGroup are looking for a Drug Safety Scientist for our multinational pharmaceutical client based in the Buckinghamshire area on an initial 12-month contract.

Main Responsibilities of the role:

Inbound Case Management
· Receipt and processing of incoming safety information from multiple sources, both internal
and external to the Company
· Entry of relevant/required safety data into the Global Safety Database from spontaneous
sources, clinical trials and other solicited sources.
· Provision of safety information/acknowledgement to marketing partners/other third party
partners/Global Medical Safety within the internal and contractual timelines
· Requesting additional information from multiple sources, both internal and external to the
· Assist with assessment of incoming information from multiple sources, both internal and
external to the Company
· Assist in the quality review of data captured in the Global Safety Database

Outbound Case Management
· Continual monitoring and assessment of reportability of Individual Case Safety Reports
due for regulatory reporting to the respective Competent Authorities (MHRA and IMB) and
Notified Bodies (British Standards Institution (BSI))
· Quality review of expedited assessments prior to submission
· Provision of safety information to Competent Authorities/Notified Bodies within required
regulatory timelines

Additional Activities
· Accurate and timely documentation of deviations to process/timelines. Including root
cause analysis and documentation of Corrective and Preventive Actions (CAPAs)
· Support all occurrences of internal and external audits and inspections
· Ensures all assigned training is completed in a timely manner
· May be involved in mentoring/training of staff and/or third party partners with
respect to pharmacovigilance

Desired Background and Skillset of the successful candidate

  • Awareness of and familiarity with industry principles of drug development and
  • Proficiency in global and local SOPs
  • Computer literate with expert knowledge of the Global Safety Database and/or expedited
    reporting module(s)
  • Ability to prioritise and work to strict timelines on a daily basis
  • Excellent verbal and written communication skills
  • Ability to negotiate and communicate with internal and external customers
  • Ability to work effectively as a member of the Drug Safety and broader Medical
    Department teams
  • Knowledge and understanding of key legislation applicable to pharmacovigilance in the
    UK and Ireland
  • Proven expertise and experience in pharmaceutical regulations and R&D processes is
  • Degree-level qualification (ideally in life sciences) or equivalent nursing qualification
  • Registration with official governing bodies e.g. General Medical Council, Royal Society of Pharmacists

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.