Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - English & German

PrimeVigilance; München; Remote; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

A leading company in pharmacovigilance is seeking a Local Contact Person for Pharmacovigilance and Regulatory Affairs based in München. This role requires strong knowledge of regulatory requirements and experience in pharmacovigilance, acting as the main liaison with local authorities. Join a dynamic team focused on making a significant impact on patient safety and product compliance.

Leistungen

Training and career development opportunities

Friendly, supportive working environment

Qualifikationen

• 3 years experience in pharmaceutical/CRO or regulatory authority.
• 2 years experience in pharmacovigilance role.
• Fluent in English and German, written and verbal communication.

Aufgaben

• Primary contact with local regulatory authorities.
• Oversee pharmacovigilance activities at the local level.
• Ensure compliance with local regulations and MAH's procedures.

Kenntnisse

Communication

Regulatory Intelligence

Pharmacovigilance Knowledge

Proficiency in Microsoft Office

Ausbildung

Bachelor's Degree in Life Sciences or Chemistry

Jobbeschreibung

Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - English & German

Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - English & German

3 days ago Be among the first 25 applicants

Company Description

PrimeVigilance (part of Ergomed Group), is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

Company Description

PrimeVigilance (part of Ergomed Group), is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

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 and German, 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.

remote

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Pharmaceutical Manufacturing

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Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - English & German

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