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Drug Safety manager

  • Job reference: 920615
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 12/07/2018

OrionGroup are looking for a Drug Safety Manager on behalf of our multinational pharmaceutical client based in the Buckinghamshire area on an initial 9-month contract.

Main Responsibilities of the role:

Safety Management and Reporting

  • Supervise the collection, review and reporting of Adverse Events (AEs) and pregnancy reports obtained through spontaneous reporting, solicited reports, clinical study reports, local literature, and all other potential sources
  • Conduct initial quality review and assessment of local individual cases
  • Write, review, validate and implement the (local) operating procedures/guidelines and verify adherence
  • Manage and maintain active involvement in day-to-day AE reporting
  • Co-ordinate the follow-up of missing information in safety cases and undertake site visits for follow-up of local cases of special interest
  • Provide local data as required to support the preparation of Safety Summary reports (PSUR, DSUR, etc.)
  • Where applicable, support the Qualified Person (QP) for PV to provide safety-related regulatory communication (e.g. response to request for information from Local HA)
  • Implement compliance standards and facilitate the collection of compliance metrics as required
  • Give training on drug safety reporting of LOC personnel and maintain awareness of drug safety reporting in general

People Management

  • Manage the local PV / Drug Safety team members providing coaching and feedback
  • Work with EMEA PV to provide relevant drug safety input to the PV training plan and assist with the execution of training within the LOC
  • Direct local safety staff activities, in collaboration with GMS, to ensure that specified timelines and reporting requirements are met

Desired Experience and Skillset of the successful candidate

  • Proven ability to organise workflow activities and manage multiple critical issues
  • Awareness of and familiarity with industry principles of pharmacovigilance, drug development and pharmacology
  • Sound knowledge of Global and Local SOPs
  • Sound knowledge of GMS database systems
  • Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers
  • Ability to establish and maintain open relationships within the organisation and with authorities
  • Demonstrable knowledge of all local PV requirements and of Global aspects of drug safety
  • Demonstrated pharmaceutical industry experience including solid experience in a PV responsibility role
  • Life Science degree or equivalent nursing qualifications

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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Drug Safety Coordinator
  • Salary Negotiable
  • Job type Contract
  • Location High Wycombe, Buckinghamshire
  • Description OrionGroup are looking for a Drug Safety Coordinator for our multinational pharmaceutical client based in the Buckinghamshire are on an initial 12-month contract