ERGOMED

Local Contact Person – Pharmacovigilance, Regulatory Affairs

ERGOMED

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇭🇷 Croatia

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Job Level

Mid-LevelSenior

About the role

  • 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

  • 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 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
Benefits
  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment
  • Opportunity to work with colleagues based all over the world, with English as the company language

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
pharmacovigilanceregulatory affairsADR reportingICSR collectionrisk minimizationlocal pharmacovigilance system developmentliterature screeningcompliance with ICH GVPlocal legislation knowledgequality assurance tasks
Soft skills
effective communicationexpert adviceorganizational skillsattention to detailsupportive teamworkauditing supportproblem-solving
Certifications
degree in Pharmacydegree in Pharmacologydegree in Medical Biochemistrypharmacovigilance training