Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA)

Category: Healthcare

About the Company

PrimeVigilance (part of Ergomed Group) is a specialized mid-size pharmacovigilance service provider established in 2008. We have achieved consistent global organic growth, with staff across Europe, North America, and Asia providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. PrimeVigilance supports small to large pharmaceutical and biotechnology partners, maintaining long-lasting relationships and establishing itself as a global leader in the field, covering all therapy areas including medical devices.

We invest in our staff through excellent training and development platforms. We value employee experience, well-being, and mental health, recognizing that a healthy work-life balance is critical for job satisfaction and achieving high-quality client service. Join us to make a positive impact on patients' lives.

Job Description

The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) acts as the primary local representative to ensure compliance with national pharmacovigilance and regulatory requirements. This dual role involves executing PV and RA activities locally, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle.

Main responsibilities

• Serve as the primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirements.
• Ensure prompt and effective communication with local regulatory authorities.
• Provide local regulatory intelligence screening and expert advice.
• Manage the collection and reporting of locally suspected Adverse Drug Reactions (ADRs) or Individual Case Safety Reports (ICSRs), including follow-ups and translations.
• Local management and oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues.
• Prepare and collect documentation for submissions to the regulatory authorities.
• Review and provide linguistic input on local Product Information and Mock-ups.
• Develop and implement the local pharmacovigilance system in compliance with the Global MAH's system and local regulations.
• Perform local non-indexed literature screening and screening of regulatory authority website(s) for potential ADRs and safety information.
• Maintain accurate records and documentation at the 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 Quality Assurance (QA) tasks such as suspected falsified products, quality alerts received from health authorities, 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 the pharmaceutical or CRO industry or a regulatory authority.
• Minimum 2 years within an LCPPV role, or relevant pharmacovigilance experience in a safety-related position.
• Pharmacovigilance training and/or working experience and other educational or professional background as required by local regulations.
• Expert knowledge of ICH GVP and relevant local legislation/regulatory requirements in territories of competency.
• Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint.
• Written and verbal proficiency in at least one of these languages: Dutch, Croatian, Czech, French, German, Italian, Polish, or Spanish.

Preferred Qualifications (Nice to Have)

• Prior experience in Regulatory Affairs is preferred but not mandatory.

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.

How to Apply

We look forward to welcoming your application.