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Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV / LCPRA) - English, Czech and Slovakian

Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV / LCPRA) - English, Czech and Slovakian

PrimeVigilancePrague, Prague, Czechia
30+ days ago
Job description

Job Description

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

Qualifications

  • 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
  • Proficiency in English, Czech and Slovakian, both written and verbal
  • Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint
  • Additional Information

    Why PrimeVigilance

    We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

    To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

    We offer :

  • 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
  • Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!

  • Quality
  • Integrity & Trust
  • Drive & Passion
  • Agility & Responsiveness
  • Belonging
  • Collaborative Partnerships
  • We look forward to welcoming your application.

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    For • Prague, Prague, Czechia