Job Purpose

Performing an accurate and scientifically sound full data entry in the Theramex Global Safety database. Provide pharmacovigilance expertise to safety surveillance & risk management, compliance; Authoring PV documents.

Key Duties and Responsibilities

• Case processing activities including triage and full data entry e.g. seriousness assessment, MedDRA coding, narrative writing of reports from post marketing sources onto the global safety database, in accordance with company SOPs and regulatory requirements; MedDRA coding
• ICSRs follow ups, ICSRs submission to various Health Authorities
• Performing AE/ SAE reconciliation
• Global Literature review using different tools (eg: Embase) and MLM service
• EudraVigilance activities including downloading ICSRs (Individual Case Safety reports) from EudraVigilance and EudraVigilance submissions
• Using and maintaining the global safety database
• Performing signal detection and risk management activities under the guidance of the PV Physician and Senior Team members; prioritising the risks and mitigation actions that provide value for patients
• Producing accurate and fit-for-purpose aggregated data review and signal evaluation documents with clear conclusions and recommendation for actions
• Authoring and/ or reviewing relevant PV or Regulatory documents for Theramex products {PSURs, RMP, RSI (SmPC/PIL), responses to Health Authorities questions etc.; contribution to study protocols
• Contribution towards the preparation of the Theramex PSMF if required

Minimum Requirements (Experience & Education)

• Bachelor or Master`s degree in Life science
• Extensive experience (over 3 years) in Drug Safety/ Pharmacovigilance and
global Pharmacovigilance regulations
• Competent with medical terminology, excellent communication abilities and possess good IT skills
• Previous use of safety databases and EudraVigilance is an advantage
• Demonstrable multitasking, project management and execution skills
• Work independently but also as part of a team
• Understanding of GVP modules and European Regulations
• A high standard of organization, narrative writing and impeccable attention to detail is essential
• Must be eligible to work in Poland
• Ability to communicate effectively in English both orally and in writing is essential