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Drug Safety Coordinator

  • Job reference: 922282
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 23/10/2018

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

POSITION SUMMARY:

Responsible for the receipt and data entry of adverse event reports following Company Standard Operating Procedures, internal business practices and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate policies.

Main Responsibilities of the role

Case Registry/Entry: The preparation of a case, from receipt to initial assignment in the database. Activities include:

  • Retrieval of cases from incoming faxes, files and/or electronic case receipt system, as applicable
  • Creation of transmittal form and/or electronic documentation of key information, as applicable
  • Liaison with Case Processing staff, to clarify information
  • Clarification of unclear or illegible information with LSO, Call Centre, etc
  • Conducting duplicate searches to determine if case is initial or follow-up
  • Creation of case file (paper or electronic)
  • Registry of case to complete basic data entry registry fields
  • Assignment of MFR/AER number
  • Send case numbers to LSOs/Call Centre, etc., as applicable

Case Processing: The completion of case information in the database, culminating in Quality Review to ensure accuracy and completeness.

Activities include:

  • Completion of remaining case data entry, including narrative or autonarrative for non-serious cases, as required
  • Completion of transmittal form, if applicable
  • Request deletions/edits, as necessary

Processes and Procedures: Understand and follow GMS systems and procedures.

Activities include:

  • Completion of all assigned training on company and GMS procedural documents relating to case receipt/processing
  • Completion of training for relevant PV Agreements for assigned products
  • Provide assistance in supporting revision/creation of case receipt procedural documents
  • Project Work, Audits, Inspections and other Ad-hoc Requirements: Participate in GMS projects, preparation for audits and inspections Activities Include:
  • Assist in supporting inspections and audits (e.g., interviews, as required)
  • Provide support for local or global project teams

Mentoring: Enhancement of the formal training program, through the provision of on-going, on-the-job guidance and support Activities Include:

  • Assist with provision of on-the-job training and support to other Safety Coordinators

Desired Experience or Skillset of the successful candidate

  • High School graduate in the US
  • Education to GCSE level in the UK
  • Previous office experience desired
  • Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas. Drug safety experience is desired.
  • Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred.
  • Basic written and verbal communication skills
  • Ability to sort, index and transmit fax/electronic documents
  • Good computer skills (Word, Email) and familiarity with safety systems
  • Data entry experience
  • Ability to work independently and accountability for delivery of results
  • Decision making skills
  • Ability to follow procedural guidelines, working practices, etc.
  • Quality orientation with attention to detail and accuracy
  • Demonstrated Flexibility/Adaptability with positive attitude
  • Good team player willing to collaborate
  • Understanding of medical terminology and ability to summarize medical information

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.