CONSULTANT(E) EN RECRUTEMENT PSYCHOLOGUE H / F

Engel & Völkers; Paris; Sur place; EUR 40 000 - 80 000; Plein temps

Résumé du poste

An exciting opportunity awaits for a freelancer/consultant to join a dynamic team as a Local Contact Person for Pharmacovigilance and Regulatory Affairs. This role offers the chance to work in a multicultural environment, enhancing your expertise in a fast-growing company. You will be responsible for managing communications with local regulatory authorities, providing critical insights, and ensuring compliance with safety regulations. With a strong emphasis on personal and professional growth, this position is perfect for those looking to advance their careers while contributing to improving the lives of others. Join a team that values diversity and collaboration, and be part of a company that prioritizes quality and integrity.

Prestations

Competitive salary

Dynamic team environment

Multicultural workplace

Personal and professional growth opportunities

Extensive training in pharmacovigilance

Friendly working environment with social events

Qualifications

• Bachelor's degree in relevant field required with experience in pharmacovigilance.
• Must have prior experience in regulatory roles and proficiency in English.

Responsabilités

• Act as primary contact for local regulatory authority and provide expert advice.
• Manage local oversight of risk minimization measures and safety issues.
• Support audits and handle local QA tasks related to quality alerts.

Connaissances

Pharmacovigilance

Regulatory Affairs

Communication Skills

Analytical Skills

Team Collaboration

Problem Solving

Formation

Bachelor's Degree in Life Sciences or Chemistry

Nursing or equivalent experience

Outils

MS-Office

Description du poste

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Travailleur Social • Fontenay-sous-Bois

Dernière mise à jour: il y a 4 jours

Description de poste

This is an exciting opportunity for a freelancer / consultant to join our team as Local Contact Person for Pharmacovigilance and Regulatory Affairs at 0.5 FTE.

By working with us, you will have the opportunity to work in an international team and strengthen your expertise within the broad and diverse PV and Regulatory Affairs area.

Main responsibilities

1. Primary contact person for local regulatory authority / Pharmacovigilance expert as per local requirements
2. Prompt and effective communication with local regulatory authorities
3. Provision of local regulatory intelligence screening and expert advice
4. Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations)
5. Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues
6. Review and linguistic input on local Product Information and Mock-ups
7. Perform local non-indexed literature screening and screening of Regulatory Authority websites for potential Adverse Drug Reactions (ADRs) and safety information
8. Support audits and Inspections
9. Handle local QA tasks such as suspected falsified products, quality alerts received from HA and other quality-related requirements received from the local market

Qualifications

1. Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent experience
2. Demonstrated experience within pharmaceutical or CRO industry or Regulatory body
3. Must have experience within LCPPV / LCPRA roles
4. PV training and / or working experience and other educational or professional background as required locally
5. Expert knowledge of ICH GVP and most relevant legislation / local requirements for territories of competency
6. Proficiency in English, both written and verbal and in local language
7. Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
8. Must currently be set up to work as a freelancer / consultant

Additional Information

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.

Our Offer

1. Competitive salary
2. Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
3. Multicultural environment, English as a company language
4. Strong emphasis on personal and professional growth
5. Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals
6. Friendly working environment with several social events per year

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!

1. Quality
2. Integrity & Trust
3. Drive & Passion
4. Agility & Responsiveness
5. Belonging
6. Collaborative Partnerships

We look forward to welcoming your application.