Full-Time LCPPV/LCPRA - English & Dutch languages required
Ergomed is hiring a remote Full-Time LCPPV/LCPRA - English & Dutch languages required. The career level for this job opening is Experienced and is accepting Guildford, United Kingdom based applicants remotely. Read complete job description before applying.
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Ergomed
Job Title
LCPPV/LCPRA - English & Dutch languages required
Posted
Career Level
Full-Time
Career Level
Experienced
Locations Accepted
Guildford, United Kingdom
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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 person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirements
- 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 (FUs, translations)
- Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues
- 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 in compliance with Global MAH's system and local regulations
- 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 such as suspected falsified products, quality alerts received from health authorities and other quality-related requirements received from the local market
Requirements:
- Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
- Previous Pharmaceutical or CRO industry or regulatory authority
- Previous experience within LCPPV role, or relevant pharmacovigilance experience in safety-related position
- Pharmacovigilance training and/or working experience and other educational or professional background as required by local regulations
- Prior experience in Regulatory Affairs is preferred but not mandatory
- Expert knowledge of ICH GVP and relevant local legislation/ regulatory requirements in territories of competency
- Proficiency in English and Dutch, both written and verbal
- Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint
FAQs
What is the last date for applying to the job?
The deadline to apply for Full-Time LCPPV/LCPRA - English & Dutch languages required at Ergomed is
3rd of September 2025
. We consider jobs older than one month to have expired.
Which countries are accepted for this remote job?
This job accepts [
Guildford, United Kingdom
] applicants. .
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