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Drug Safety Assistant

  • Job reference: 923084
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 17/12/2018

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

Job Description:

Execute drug safety support activities as required for Marketing Authorisation Holders (MAH's) and/or study sponsor, as applicable with Good Pharmacovigilance Practice regulation.

PRINCIPAL RESPONSIBILITIES:
Call handling:
* 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 60


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 as required 40

REPORTING RELATIONSHIPS:
The Drug Safety Assistant reports to the (Senior) Drug Safety Manager

EDUCATION & EXPERIENCE REQUIREMENTS:
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

Other comments:
Fluency in English language required.
Occasionally flexible working hours


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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