Job Purpose
Performing an accurate and scientifically sound full data entry in the Theramex
Global Safety database. In addition, the candidate will gain exposure to many
different aspects of Pharmacovigilance.
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
- Contribution to signal detection and risk management activities under the guidance of the PV Physician and Senior Team members; prioritizing the risks and mitigation actions that provide value for patients
- Contribution to relevant PV or Regulatory documents for Theramex products {PSURs, RMP, RSI (SmPC/PIL), responses to Health Authorities questions etc.
- Contribution towardsthe preparation of the Theramex PSMF if required
- Supporting / participating in PV audits and inspections if required
- Contributing to the on-going enhancement of the Pharmacovigilance processing and writing Standard Operating Procedures and Working practices
- Processing PV related deviations and CAPAs(Corrective and Preventive actions)
- Any other duties that can be reasonably added to this role
Minimum Requirements (education, experience & skills)
- Bachelor or Master`s degree in Life sciences
- Relevant experience (min 2 years) in Case Processing and/or Drug Safety/
Pharmacovigilance and global Pharmacovigilance regulations - Competent with medical terminology, excellent communication abilities
and possess good IT skills - Previous usage 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 - Ability to communicate effectively in English both orally and in writing is
essential
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