Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPVLCPRA) English & German

Ergomed; Frankfurt; Remote; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company in Frankfurt is seeking a Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs. The role includes ensuring compliance with national regulations and managing local PV and RA activities. Requires a Bachelor's degree in Life Sciences or Chemistry and significant experience in the field. Proficiency in both English and German is necessary. The position offers a supportive work environment with opportunities for growth.

Leistungen

Training and career development opportunities

Strong emphasis on personal and professional growth

Friendly supportive working environment

Opportunity to work with international colleagues

Qualifikationen

• Minimum 3 years within pharmaceutical or CRO industry or regulatory authority.
• Minimum 2 years within LCPPV role or relevant pharmacovigilance experience.
• Proficiency in English and German both written and verbal.

Aufgaben

• Serve as the primary local representative for compliance.
• Prepare and collect documentation for submissions to regulatory authorities.
• Provide support to the RA & PV Global operations team.

Kenntnisse

Proofreading

Adobe Acrobat

FDA Regulations

Biotechnology

Clinical Trials

Research & Development

GLP

cGMP

Product Development

Chemistry

Writing Skills

Ausbildung

Bachelors Degree in Life Sciences or Chemistry

Tools

Microsoft Office

Jobbeschreibung

Main responsibilities

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.

• 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 MAHs 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 MAHs and PrimeVigilances 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

• Bachelors 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.

#LI remote

Remote Work: Yes

Employment Type: Full-time

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Experience: years

Vacancy: 1