Case Manager
Mindoula
Local Contact Person, Pharmacovigilance and Regulatory Affairs
ERGOMED
full-time
Posted on:
Origin: • 🇭🇷 Croatia
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Act as primary local contact person 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 (follow-ups, 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 websites for potential 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 and other quality-related requirements from the local market
Requirements
- Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
- Minimum 3 years within pharmaceutical or CRO industry or regulatory authority
- Minimum 2 years 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
- 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, including Word, Excel, and PowerPoint
