Accessibility Links

Drug Safety Assistant

  • Job reference: 923893
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 12/02/2019

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


Principal Responsibilities:
* Execute drug safety support activities as required for Marketing Authorisation Holders (MAH's) and/or study sponsor, as applicable to ensure the Company complies with Good Pharmacovigilance Practice regulation.

  • 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 various 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 that due inbox
    * Support TFUP questionnaire reconciliation
    * Monitor due diligence schedule process
    * Clinical scan and attach files into sceptre
    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
    * Administers the due diligence process to ensure completeness of case reports and timely distribution of follow-up requests
    * Managing post
    * Letter writing
    * Loose filing and IRT processing
    * Files maintains and archives all case materials, including original source documentation
    * Support CSTL / LSO in responding to ad hoc requests.

    Essential Knowledge & Skills
    * Awareness of and familiarity with medical terminology
    * Proficiency in global and local SOPs
    * Computer literate with expert 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 communicate with internal and external customers
    * Ability to work effectively as a member of the Drug Safety and broader Medical Department teams


Experience
* Previous experience in a similar/related role is desirable


Education
* Degree-level qualification (ideally in life science) or equivalent qualification

RELATED EXPERIENCE:
0-2 years


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.

Similar jobs
Regulatory Affairs CTA Manager
  • Salary Negotiable
  • Job type Contract
  • Location High Wycombe, Buckinghamshire
  • Description Orion Group are looking for a Regulatory Affairs CTA Manager for our multinational pharmaceutical client based in the Buckinghamshire area on an initial 12-month contract with the potential to extend
Submission Specialist-Junior
  • Salary Negotiable
  • Job type Contract
  • Location High Wycombe, Buckinghamshire
  • Description Orion Group are looking for a Submission Specialist-Junior for our multinational pharmaceutical client based in the Buckinghamshire area on an initial 4-month contract with the potential to extend