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Local Contact Person For Pharmacovigilance And Regulatory Affairs (Lcppv/Lcpra) - Italian, Fren[...]

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Lombardia

Remoto

EUR 40.000 - 60.000

Tempo pieno

2 giorni fa

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Descrizione del lavoro

A leading pharmacovigilance service provider seeks a Local Contact Person for Pharmacovigilance and Regulatory Affairs. This role ensures compliance with regulations and supports product lifecycle management, involving duties such as interaction with regulatory authorities and local ADR reporting. Ideal candidates have a Bachelor's in Life Sciences and relevant experience.

Servizi

Training and career development opportunities

Supportive working environment

Opportunity to work globally

Competenze

Minimum 3 years within pharmaceutical or CRO industry.
Minimum 2 years in LCPPV role.
Pharmacovigilance training and/or experience.

Mansioni

Primary contact with local regulatory authorities.
Collection and reporting of locally suspected ADRs.
Support audits and Inspections.

Conoscenze

Proficiency in English

Proficiency in Italian

Proficiency in French

Communication

Analyzing regulatory requirements

Formazione

Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent

Strumenti

Microsoft Office

Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - Italian, Fren[...]

Remoto

EUR 40.000 - 60.000

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

Join to apply for the Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - Italian, French & English role at PrimeVigilance

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

Join to apply for the Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - Italian, French & English role at PrimeVigilance

Direct message the job poster from PrimeVigilance

Talent Acquisition Specialist II at ERGOMED

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, Italian and French 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!