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

Ergomed; Madrid; A distancia; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

Join a leading pharmacovigilance service provider as a Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs. This dual-role position ensures compliance with national regulations, engages with local authorities, and oversees essential safety measures. The ideal candidate possesses a strong educational background in life sciences, along with at least three years of relevant industry experience. Contribute to making a positive impact in patients' lives while enjoying opportunities for personal and professional growth.

Servicios

Training and career development opportunities

Friendly, supportive working environment

Opportunities to work with global colleagues

Formación

• Minimum 3 years in pharmaceutical or CRO industry.
• Minimum 2 years in LCPPV role or relevant pharmacovigilance experience.
• Expert knowledge of ICH GVP and relevant local legislation.

Responsabilidades

• Serve as primary contact with local regulatory authorities.
• Prompt communication with local regulatory authorities.
• Conduct local management of risk minimization measures.

Conocimientos

Proficiency in English

Proficiency in Spanish

Strong skills in Microsoft Office applications

Educación

Bachelor's Degree in Life Sciences or Chemistry, Nursing

Descripción del empleo

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