Eu Qppv Office Specialist
il y a 2 semaines
We are currently looking for a QPPV Office Specialist, who will support the EU QPPV office to ensure all EU and other local pharmacovigilance deliverables including systems and processes are implemented and maintained in compliance with regulatory requirements.
Roles & Responsibilities:
- Serve as the main contact point to support the local pharmacovigilance responsible person (LPVRP) not only in EU but also other territories aligned to the QPPV responsibilities
- Contact point for LPVRP when update of the Pharmacovigilance System Master File (PSMF) is required
- Coordinate and maintain the ongoing QPPV office management activities
- Establish, facilitate, and maintain regular interactions with LPVRP, program teams and other cross functional groups with regard to compliance related to safety data and processes that involve Global Patient Safety (GPS)
- Work closely with GPS management contributing to the planning, and implementation of GPS activities supporting strategic EU projects
- Identify and communicate internally at GPS potential pharmacovigilance updates that can impact the global GPS function
- Support the preparation of GPS documents and processes (including SOPs, work instructions, PSMF, RMP, PSUR, pharmacovigilance agreements or signal detection)
- Support GPS inspections and internal audits
- Maintain knowledge of EU and global regulatory requirements as applicable to drug safety and pharmacovigilance
Skills, Competencies & Qualifications:
- Excellent planning and organizational skills
- Excellent oral and written communication skills.
- Demonstrated ability to collaborate with multidisciplinary teams and manage multiple projects simultaneously
- Solution oriented with ability to work independently
- Ability to clearly communicate complex issues
- Relevant computer skills, including proficiency with MS Office and EudraVigilance environment
- Fluency in written and spoken English. Other EU languages are a plus but not required
- Bachelor’s degree in related scientific field (MD, PhD or Master’s degree a plus)
- At least 3 years of experience in the pharmaceutical/biotech industry with at least 2 years in pharmacovigilance/drug safety
- Knowledge of the maintenance of the PSMF and developing standard operating procedures (SOP).
- Knowledge of EU-pharmacovigilance regulatory requirements
- Experience in attending EU-PV inspections
- Experience as Local PV Responsible Person is preferred
- Experience with regulatory submissions and medical writing is preferred
LI-Onsite
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