(3 Days Left) Senior Safety Scientist

3 weeks ago

Dublin, Dublin City, Ireland CPL Full time
Drug Safety Scientist - Senior Manager - Hybrid/Remote


This role is responsible for providing expertise in implementing and maintaining a robust global pharmacovigilance (PV) compliance program within Global Drug Safety & Pharmacovigilance (GDSP) in close collaboration with Quality Assurance (QA).

The Manager, PV Compliance will also support GDSP in internal audits and regulatory inspections.

Key Duties will include:

  • Assist in development and maintenance of systems to oversee and track compliance with pharmacovigilance regulatory requirements to assure continuous quality improvement. This includes, but is not limited to, monitoring the timeliness of regulatory reporting of ICSRs and all periodic reports, monitoring data exchange with all vendors and partner companies, and tracking PV staff and vendor training requirements. Develops additional KPIs where needed to ensure proper overview of the PV system's performance.
  • May present monthly KPI compliance data at routine GDSP department meetings. Contributes to drive departmental process improvements and best practices for compliance and effectiveness.
  • Assists with maintenance, in collaboration with QA, of mechanisms to track and report GDSP Deviations, and Corrective and Preventive Actions (CAPAs); follows opened Deviations and CAPAs to ensure on time completion/closure. Identifies gaps and conducts non-compliance investigations as needed. Alerts Management of significant deficiencies in PV quality and compliance standards.
  • Assists management with review and analysis of audit, inspection and CAPA data and reports to identify compliance trends and areas of exposure related to pharmacovigilance.
  • Tracks measurable KPIs for all PV vendors and partners as per the terms of existing Pharmacovigilance Agreements (PVAs).
  • Performs quality control of monthly and annual submission compliance data and performs trending on root causes for late submissions to identify areas for process improvement.
  • Assists with quality control review of individual case data entry on a set percentage of cases on a regular basis and tracks data entry compliance.
  • Provides support to the review and development of written procedures to ensure that the pharmacovigilance system is compliant with governing regulations and is adequately described in Quality Management System documents.
  • Partners with members of the QA Department to align PV compliance processes and procedures with existing or required quality processes.
  • Maintains an in-depth knowledge of global pharmacovigilance regulations and requirements.
  • Other duties as assigned.

The successful candidate will have:

Life-science degree such as PhD in scientific field, pharmacy degree, MS or BS in scientific field, MPH, BS Nursing

Minimum of 6 years in pharmacovigilance in a pharmaceutical or biotech environment required, with a thorough understanding of signal detection and assessment

Expert knowledge of FDA safety regulations, EMA safety regulation, GVP, ICH Guidelines, and other applicable regulatory guidance documents; expertise in global pharmacovigilance regulations.

Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities

Strong understanding of epidemiologic principles

Strong knowledge of global pharmacovigilance regulations

Strong organizational skills, timeline management, and ability to work in matrixed teams.

For more information, please contact [email protected]

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