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Drug Safety Assistant

High Wycombe, Buckinghamshire

Negotiable

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Orion Group are recruiting for a Drug safety Assistant on behalf of our Multinational Pharmaceutical Client on an initial 6 month contract based in the Buckinghamshire Area on a Part-Time Basis of 2 days a week POSITION SUMMARY: Execute drug safety support activities as required for Marketing Authorisation Holders (MAH's) and/or study sponsor and comply with Good Pharmacovigilance Practice regulation. Responsibilities Include:Answer inbound calls from general public, HCPs, internal colleagues to elicit and capture relevant adverse event dataEnter relevant/required safety data into the Global Safety Database from various sourcesRequest additional information from multiple sources, both internal and external to the companyConfirm that requests for additional follow-up has been sent to reporters as appropriate through review of due diligence reconciliation reports and monitoring that due inboxSupport TFUP questionnaire reconciliationMonitor due diligence schedule processClinical scan and attach files into sceptreReview case files and/or processes as directed to support internal and external audits and inspectionsComplete all assigned training in a timely mannerAdministers the due diligence process to ensure completeness of case reports and timely distribution of follow-up requestsManaging postLetter writingLoose filing and IRT processingFiles maintains and archives all case materials, including original source documentationSupport CSTL / LSO in responding to ad hoc requests as requiredDesired Experience and Background of the successful candidateAbility to work effectively as a member of the Drug Safety and broader Medical Department teamPrevious experience in a similar/related role is desirableDegree-level qualification (ideally in life science) or equivalent qualificationAwareness of and familiarity with medical terminologyProficiency in global and local SOPsComputer literate with expert knowledge of the Global Safety DatabaseAbility to prioritise and work to strict timelines on a daily basisExcellent verbal and written communication skillsAbility to communicate with internal and external customerOur role in supporting diversity and inclusionAs 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.

Posted 53 days ago

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