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.
