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Drug Safety Associate

  • Job reference: 930734
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 09/04/2020

Orion Group are recruiting for a Drug Safety Associate on behalf of our Multinational Pharmaceutical Client on an initial 6 month contract based in the Buckinghamshire Area

Principal Responsibilities:

  • Triage of incoming cases to prioritize for daily workflow management
  • Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness
  • Completion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approval
  • Preparation of SUA summary: Analysis of Similar Events
  • Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.
  • Liaison with Case Receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing
  • Single case unblinding, Serious Adverse Event (SAE) /Adverse Event (AE) reconciliation, deviation memo preparation, deletion/admin edit requests, review protocol update request forms for accuracy
  • Completion of all assigned training on company and GMSO procedural documents relating to case processing
  • Completion of training relating to relevant PV Agreements for assigned products
  • Participate in designated activities to support revision/creation of case processing procedural documents

Project work: participation in assigned projects, including inspection/audit readiness activities

  • Participation in local or global project teams, including on-time delivery of assigned responsibilities
  • Participation in inspections and audits as identified, including interviews and provision of requested data
  • Operational and project related contact with staff in GMSO (all functional groups), Compliance Strategy and Analytics (CSA), Medical Safety Surveillance and Insights (MSSI)
  • Customer Interfaces
  • Global Medical Safety/QPPV staff
  • Operational and project related contact with relevant staff in assigned customer sector (Pharma/Consumer), including e.g. LSOs, clinical and regulatory affairs personnel

Desired Experience:

  • Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD)
  • Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification)
  • Licensed Practical Nurse with Bachelors degree, or with knowledge of pharmacovigilance usually exhibited by minimum 5 years' experience in pharmaceutical safety-related role
  • Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas. Case processing experience is desired
  • Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred
  • Understanding of medical terminology and ability to summarize medical information
  • Ability to follow guidelines and procedural documents (experience of working with SOPs etc preferred)
  • Oriented to quality, attention to detail and accuracy
  • Manages own work: ability to prioritize, plan and organize work assignments, and able to work under strict timelines

#Pharmaceutical #multinational #product #drugsafety #CAPA #PV #pharmacovigilance

For more information on this role, call Denise Cagney on +353 (0) 212063405 or email Denise.Cagney@orioneng.com for a completely confidential chat about this role


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.