Freelance / Consultant 0.5 Fte Local Contact Person for Pharmacovigilance and Regulatory Affairs

20 ore fa


Roma, Lazio, Italia Primevigilance A tempo pieno
Job Description

We are seeking a highly skilled Freelance/Consultant to join our team as a Local Contact Person for Pharmacovigilance and Regulatory Affairs at 0.5 FTE.

Main Responsibilities
  • Act as the primary contact person for local regulatory authorities and pharmacovigilance experts.
  • Provide prompt and effective communication with local regulatory authorities.
  • Screen and provide local regulatory intelligence, as well as expert advice.
  • Collect and report locally suspected ADRs or ICSRs (FUs, translations).
  • Manage and oversee local risk minimization measures related to urgent safety restrictions and emerging safety issues.
  • Review and provide linguistic input on local Product Information and Mock-ups.
  • Perform local non-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 quality-related requirements received from the local market.
Requirements
  • Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent experience.
  • Demonstrated experience within the 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 PowerPoint.
  • Must currently be set up to work as a freelancer/consultant.
About Us

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.

We believe that our people are our greatest strength, leading to our continued success in improving the lives of those around us.

Our core values are key to how we operate:

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

We look forward to welcoming your application.


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