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Drug Safety Associate

Drug Safety Associate

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Drug Safety Associate

  • Location:

    England

  • Sector:

    Pharmacovigilance - Pharma

  • Contact:

    Jonathan Buggs

  • Salary:

    Negotiable

  • Job type:

    Interim/Contract

  • Contact email:

    Jonathan.Buggs@msipharma.com

  • Job ref:

    JBDrugAssNov23_1701340248

  • Published:

    3 months ago

  • Duration:

    12 months

  • Startdate:

    ASAP

We are currently seeking a highly skilled and motivated Drug Safety Associate to join our dynamic team.

Key Measures of Success:

  • Efficient and consistent processing of adverse event reports from worldwide sources.
  • Expedited reporting compliance with applicable regulatory requirements and pharmacovigilance contracts.
  • Timely handling of adverse event reports from different sources, meeting metrics and KPIs.
  • ICSR quality above defined thresholds as per applicable KPIs and metrics.
  • Fulfillment of all legal obligations related to adverse reactions in clinical development projects.
  • Presentation of safety data in a timely and appropriate manner for benefit-risk assessment and aggregate reporting.
  • Up-to-date and compliant Standard Operating Procedures for drug safety case management.

Responsibilities:

  • Coordinate all safety data processing, including intake, triage, data entry, and quality control.
  • Manage expedited reporting and ensure compliance for spontaneous and solicited reports.
  • Present safety data from spontaneous and solicited sources.
  • Liaise internally and externally with other departments, consultants, partners, and service providers.
  • Conduct pharmacovigilance quality control.
  • Handle special duties on assignment.

Tasks:

  • Perform triage and processing of safety data from worldwide sources.
  • Track inbound and outbound communication related to individual safety cases.
  • Process individual cases according to company procedures and regulatory requirements.
  • Oversee case management vendor performance and quality.
  • Ensure consistency in case classification, causality, labeling, MedDRA, WHO-Drug coding, and narratives.
  • Liaise with other Drug Safety Associates and stakeholders regarding case processing tasks.
  • Handle clinical safety reporting in compliance with regulatory requirements.
  • Coordinate case follow-up activities and reconciliation with Health Authorities/Contractual Partners/CRO's.
  • Check screen results for case inclusion and safety relevance for literature cases.
  • Liaise with affiliates and partners for expedited compliance.
  • Collaborate with DS technologies and ARISg administrator group regarding E2B reporting, database management, and custom reporting.
  • Ensure compliance with SOPs.
  • Liaise with Quality Assurance in handling Product Technical Complaints associated with adverse events.
  • Provide training in the area of expertise as a trainer on an as-needed basis.

Minimum Requirements:

  • University degree in pharmacology/medicine/healthcare/other life sciences.
  • Working experience in post-marketing surveillance/drug safety operations.
  • Fluency in English.
  • Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook).
  • Need to have British Citizenship, or right to work in the UK.

Preferred Requirements:

  • Experience with drug safety databases (especially ARISg).
  • EudraVigilance certification.
  • Experience in audits and inspections.
  • German or French language skills.

Competencies:

  • Good communication skills, orally and in writing.
  • Strong analytical skills.
  • In-depth knowledge of life sciences, pharmaceuticals, and medical aspects related to drug safety.
  • Strong organizational skills with a good sense of prioritization.
  • Coordination capability of peer teams and out-contracted activities.
  • Ability to develop good working relationships with service providers and worldwide partners.
  • Effective cross-functional working ability.
  • Strong team working ability.
  • Proactive and solution-oriented approach.