Freelance / Consultant 0.5 FTE Local Contact Person for Pharmacovigilance and Regulatory Affair[...] Lisboa

Freelance / Consultant 0.5 FTE Local Contact Person for Pharmacovigilance and Regulatory Affair[...]
Lisboa
Lisboa, Lisboa, Portugal

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Freelance / Consultant 0. 5 FTE Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA), Lisbon

Client:

Location:

Lisbon, Portugal

Job Category:

Other

EU work permit required:

Yes

Job Reference:

7eb8f87db3d8

Job Views:

3

Posted:

21. 03. 2025

Expiry Date:

05. 05. 2025

Job Description:

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

• Primary contact person for local regulatory authority / Pharmacovigilance expert 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
• Review and linguistic input on local Product Information and Mock-ups
• Perform local
  - indexed literature screening and screening of Regulatory Authority website/s for potential Adverse Drug Reactions (ADRs) and safety information
• Support audits and Inspections
• Handle local QA tasks such as suspected falsified products, quality alerts received from HA, and other
  - related requirements received from the local market

Qualifications

• Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent experience
• Demonstrated experience within pharmaceutical or CRO industry or Regulatory body
• Must have experience within LCPPV / LCPRA roles
• PV training and/or working experience and other educational or professional background as required locally
• Expert knowledge of ICH GVP and most relevant legislation/local requirements for territories of competency
• Proficiency in English, both written and verbal and in local language
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and Power
  Point
• 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
- 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 in improving the lives of those around us.

Our Offer

• Competitive salary
• Dynamic team of colleagues in a
  - growing company – possibility for your quick career growth
• Multicultural environment, English as a company language
• Strong emphasis on personal and professional growth
• Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals
• 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 Prime
Vigilance could be a great company to join!

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

We look forward to welcoming your application.