Ergomed
Local Contact Person for Pharmacovigilance and Regulatory Affairs (Permanent or Contractor)
Ljubljana, Ljubljana, Slovenia · Remote (restrictions not stated) · Full-time
Apply on the employer’s site ↗See how well you match this job
You apply directly with the employer. ROLIVA does not submit applications from this page and is not the employer.
About the role
Description from the employer’s posting. Check the employer’s page for the current version.
- EmployerErgomed
- LocationLjubljana, Ljubljana, Slovenia
- Work styleRemote (restrictions not stated)
- Employment typeFull-time
- Employer posted
The Specialist, Local RA & PV Network will act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) and serves as the primary local RA&PV representative to ensure compliance with national pharmacovigilance and regulatory requirements in Australia. This 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
- Prompt and effective communication with MAH and local regulatory authorities as required
- Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirements
- Provision of local regulatory intelligence screening and expert advice for the responsible region(s)
- 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
- Support with 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
- Preparation and collection of documentation for submissions to the regulatory authorities
- Review and linguistic input on local Product Information and Mock-ups
- 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
Show full description
- Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
- At least 3 years of pharmacovigilance or safety-related experience in pharmaceutical, CRO, or regulatory environment
- Good understanding of ICH GVP and local pharmacovigilance requirements (training or practical exposure)
- Experience in case handling, literature screening, or local PV activities is preferred
- Prior experience in Regulatory Affairs is preferred but not mandatory
- Proficiency in English and additional language knowledge is advantageous
- Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
- Quality: we hold ourselves to the standard patients deserve.
- Integrity and trust: we do the right thing, especially when it is hard.
- Drive and passion: we care about the outcome, because someone is waiting on it.
- Agility and responsiveness: we move quickly, because patients cannot wait.
- Belonging: everyone is welcome, and every voice counts.
- Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.
Check your resume against this job Free, no sign-up. Nothing you paste is stored.
Staying safe while you apply
- Never pay to apply, interview or accept an offer. ROLIVA never asks you for payment to apply to a job.
- Apply only through the official “Apply on the employer’s site” button, on the employer’s own site, and check that a recruiter’s email uses that employer’s own domain rather than a free email address.
- Be cautious of an offer made with no real interview, or pressure to decide quickly or share financial details early.
Does something look wrong with this listing? Use “Report broken link” in the role details, or read ROLIVA’s full job-safety guidance ↗.
Preparing for this role with ROLIVA
- Check the fit.
Compare the requirements with the experience you have confirmed, including gaps.
- Prepare honestly.
Build interview stories and application drafts from your own evidence.
- Keep track.
Save the role and record your own application status and follow-ups.
At a glance
- Work styleRemote (restrictions not stated)
- Employment typeFull-time
- SeniorityMid level
- Employer posted
- Added to ROLIVA
- Last checked
Skills in this posting
Skills ROLIVA found in the employer’s own description above. A mention is not a requirement.