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 dual-role position is responsible for executing PV and RA activities at the local level, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle.
Main responsibilities:
- Primary contact with local regulatory authorities for Regulatory Affairs and Pharmacovigilance.
- Prompt and effective communication with local regulatory authorities.
- Provision of local regulatory intelligence screening and expert advice.
- Collection and reporting of locally suspected ADRs or ICSRs.
- Local management / oversight of risk minimization measures.
- Preparation and collection of documentation for submissions to the regulatory authorities.
- Review and linguistic input on local Product Information and Mock-ups.
- Development and implementation of local pharmacovigilance system.
- Perform local non-indexed literature screening and screening of regulatory authority website/s for potential Adverse Drug Reactions (ADRs) and safety information.
- Maintain accurate records and documentation at local level.
- Provide support to the RA & PV Global operations team.
- Ensure compliance with MAH's and PrimeVigilance's procedures.
- Support audits and Inspections.
- Handle local QA tasks.
Requirements:
- Degree in Pharmacy, Pharmacology or Medical Biochemistry.
- Minimum 3 years within pharmaceutical or CRO industry or regulatory authority.
- Minimum 2 years within LCPPV role, or relevant pharmacovigilance experience.
- Pharmacovigilance training and/or working experience.
- Prior experience in Regulatory Affairs is preferred.
- Expert knowledge of ICH GVP and relevant local legislation/ regulatory requirements.
- Written and verbal proficiency in at least one of these languages: Dutch, Croatian, Czech, French, German, Italian, Polish or Spanish.
- Strong skills in Microsoft Office applications.
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
12th of November 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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