Sugerencias de búsqueda:

sin experiencia
limpieza
dependienta
psicólogo
recepcionista
enfermera
auxiliar enfermería
conductor autobus
con alojamiento
auxiliar administrativo
administrativo
inglés
chófer
Bajo Llobregat
Cataluña
Andalucía
Madrid
Vallés Occidental
Comunidad de Madrid
Leganés
Navarra
Aragón
La Rioja
Pamplona
Cuadrilla de Vitoria
Postular

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

Primevigilance
Madrid, Comunidad de Madrid
Tiempo completo
hace 3 semanas
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
  • 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

Guardar Postular
Reportar empleo
Otras recomendaciones de empleo:

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

Primevigilance
Madrid, Comunidad de Madrid
  • Provision of local regulatory intelligence screening and...
  • Local management / oversight of risk minimization measures...
hace 3 semanas

Qualified Person Responsible for Pharmacovigilance (QPPV) in the EU and UK (homebased)

Ergomed
Madrid, Comunidad de Madrid
  • The establishment and maintenance of a system which ensures...
  • Ensuring that any request from the CAs for the provision of...
hace 3 semanas

Senior Specialist, Regulatory & Pharmacovigilance

Ergomed
Madrid, Comunidad de Madrid
  • Act as Local Contact Person for Pharmacovigilance for the...
  • Assume leadership and functional representation for projects...
hace 3 semanas

Case Processing Manager (Pharmacovigilance), Team Lead (Europe remote/hybrid position)

Primevigilance
Madrid, Comunidad de Madrid
  • Assures and exerts of activities leading to effective...
  • Providing support to other activities undertaken by the...
hace 3 semanas

Pharmacovigilance Safety Writer

Vantive
Madrid, Comunidad de Madrid
Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams...
hace 3 semanas