Full-Time Local Contact Person - Pharmacovigilance & Regulatory
Ergomed is hiring a remote Full-Time Local Contact Person - Pharmacovigilance & Regulatory. The career level for this job opening is Experienced and is accepting Zagreb, Croatia based applicants remotely. Read complete job description before applying.
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Ergomed
Job Title
Local Contact Person - Pharmacovigilance & Regulatory
Posted
Career Level
Full-Time
Career Level
Experienced
Locations Accepted
Zagreb, Croatia
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Job Details
The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) serves as the primary local representative to ensure compliance with national pharmacovigilance and regulatory requirements. This role executes PV and RA activities, supporting product compliance throughout its lifecycle.
Main responsibilities:
- Primary contact with local regulatory authorities.
- Prompt communication with authorities.
- Local regulatory intelligence and advice.
- Collection/reporting of ADRs or ICSRs.
- Local oversight of risk minimization measures.
- Preparation of documentation for submissions.
- Review of local Product Information.
- Implementation of local pharmacovigilance system.
- Perform local non-indexed literature screening.
- Maintain accurate records.
- Support RA & PV Global operations.
- Ensure compliance with procedures.
- Support audits and Inspections.
- Handle local QA tasks.
Requirements:
- Bachelor's Degree in Life Sciences, Chemistry, Nursing, or equivalent.
- Minimum 3 years in pharmaceutical or CRO industry.
- Minimum 2 years within LCPPV role or relevant experience.
- Pharmacovigilance training.
- Prior experience in Regulatory Affairs (preferred).
- Expert knowledge of ICH GVP and local regulations.
- Proficiency in English.
- Strong skills in Microsoft Office.
FAQs
What is the last date for applying to the job?
The deadline to apply for Full-Time Local Contact Person - Pharmacovigilance & Regulatory at Ergomed is
28th of August 2025
. We consider jobs older than one month to have expired.
Which countries are accepted for this remote job?
This job accepts [
Zagreb, Croatia
] applicants. .
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