Local Contact Person For Pharmacovigilance And Regulatory Affairs (Lcppv/Lcpra) - English & Spa[...]

buscojobs España; Madrid; Presencial; EUR 30.000 - 70.000; Jornada completa

Descripción de la vacante

Un proveedor líder en farmacovigilancia busca una Persona de Contacto Local para garantizar el cumplimiento con los requisitos de farmacovigilancia y asuntos regulatorios en Madrid. El candidato ideal tendrá una licenciatura en Ciencias de la Vida o Química, con experiencia valiosa en la industria farmacéutica. Esta posición incluye gestionar la comunicación con las autoridades locales y asegurar la calidad y el cumplimiento de los productos a lo largo de su ciclo de vida.

Servicios

Oportunidades de formación y desarrollo

Ambiente de trabajo amigable y de apoyo

Formación

• 3 años de experiencia en la industria farmacéutica o CRO.
• 2 años en el rol LCPPV con experiencia en farmacovigilancia.
• Conocimiento experto de ICH GVP y regulaciones locales.

Responsabilidades

• Ser el contacto principal con las autoridades regulatorias locales.
• Recopilar y reportar ADRs sospechosas.
• Gestión local de medidas de minimización de riesgos.

Conocimientos

Comunicación efectiva

Inteligencia regulatoria

Habilidades en Microsoft Office

Proficiencia en español

Proficiencia en inglés

Educación

Licenciatura en Ciencias de la Vida o Química

Descripción del empleo

Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - English & Spa[...]

Madrid

EUR 30.000 - 70.000

Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - English & Spanish (French is also preferred)

Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - English & Spanish (French is also preferred)

3 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

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
  
  

Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - English & Spanish (French is also preferred)

Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - English & Spanish (French is also preferred)

3 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

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 Spanish, both written and verbal. French language skills are also preferred.
• 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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