Regulatory Affairs / Pharmacovigilance Associate
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Prague • Czech
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About the role
- Play a vital role in ensuring regulatory compliance and safeguarding patient safety.
- Secure regulatory approval of new products in due time.
- Maintain existing registrations and continuously update the regulatory files.
- Safety reporting.
- Regulatory Back-up to all regulatory activities and mandatory 2nd proof-reader for translations, manuscripts, RA systems.
- Prepare local submissions: Mutual Recognition, Decentralized and National Procedure, local new products, variations, renewals, PSURs etc.
- Local language labelling preparation (new and updated): translation, proof-reading, approval of proofs in system and preparation of PMI.
- Veeva Vault RIM handling (updates in Vault RIM as per valid SOPs).
- RA administrative tasks.
- Act as safety responsible person back-up in the affiliate for safety reporting of marketed products.
- Responsible for timely safety reporting to Health Authority and to Global Safety.
- Medical literature monitoring.
- Safety administrative tasks.
Requirements
- Min. bachelor’s degree in scientific or related field.
- Minimum of 2-3 years of experience in Regulatory Affairs in the pharmaceutical industry and/or in Pharmacovigilance.
- Strong knowledge of regulatory/pharmacovigilance requirements and guidelines.
- Experience with product registration, progress reports, supplements, and amendments.
- Experience with pharmacovigilance and safety reporting is an advantage.
- Familiarity with electronic records, retention processes and controlled documentation systems.
- Excellent level of Czech (written and spoken) and very good level of English (written and spoken).
Benefits
- Health insurance
- Paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory compliancesafety reportingproduct registrationpharmacovigilancemedical literature monitoringtranslationproof-readinglocal submissionscontrolled documentation systemselectronic records
Soft Skills
attention to detailcommunicationorganizational skillsinterpersonal skillstime management
Certifications
bachelor’s degree in scientific field