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Drug Safety Scientist

  • Job reference: 924315
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: R&D - Clinical & Non Clinical, Life Sciences
  • Date posted: 12/03/2019

Orion Group are recruiting for a Drug Safety Scientist on behalf of our Multinational Pharmaceutical Client on an initial 12 month contract based in the Buckinghamshire Area.

POSITION SUMMARY:
Support the coordination of safety reporting requirements as required for Marketing Authorisation Holders (MAHs) and /or study sponsor, as applicable.

PRINCIPAL RESPONSIBILITIES:
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 Company
* 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 40
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 40
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
* May be involved in completion of periodic reconciliation activities
* May be assigned as key contact for studies or partner contracts
* Support CSTL / LSO in responding to ad hoc requests as required 20


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.

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