Senior Specialist, Regulatory & PV Network
Remote · Warsaw, Mazovia, Poland
Job Summary
Senior Specialist, Regulatory and PV Network responsible for developing strategy based on regulatory requirements and for driving regulatory and PV deliverables according to the established PV and regulatory plan. Acts as a liaison between regulatory and other functional areas, external partners, clients, authorities and/or consultants in planning, organizing and preparing regulatory deliverables. Serves as Local Contact Person for Pharmacovigilance for the designated country. Leads projects of medium/high complexity, coordinates tasks to meet targets, develops strategy with senior team input, tracks training/compliance for LCPs, monitors budgets and hours, supports proposals and budgets, and provides mentorship to junior staff while maintaining strong external and internal relationships. Requires Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent, solid Pharma/CRO experience, knowledge of ICH GCP/GVP and national regs, PV training/experience, English fluency, and strong planning, collaboration, and attention to detail.
Required Qualifications
- Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
- Strong experience within pharmaceutical or CRO industry or Regulatory body
- Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency
- PV training and/or working experience and other educational or professional background as required locally
- Fluent in English, both written and verbal
- Proficiency in the official language of the country in which based
- Good planning and organizational skills
- Strong interpersonal skills in a fast-paced, deadline oriented environment
- Good attention to detail
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