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Deputy Local Qualified Person for Pharmacovigilance

Apsida Life Science

À distance

EUR 40 000 - 60 000

Plein temps

Hier
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Résumé du poste

A biotechnology company is seeking a Deputy Local QPPV for a remote-based role. This position supports compliance with EU pharmacovigilance regulations and involves acting on behalf of the Local QPPV during absences. Candidates should have a degree in Life Sciences or related field and 2-4 years of pharmacovigilance experience, specifically with French regulations. This role is for a 12-month contract, offering a unique opportunity to work in a dynamic environment focused on innovative therapies.

Qualifications

  • Minimum 2–4 years of pharmacovigilance experience, preferably including EU PV requirements.
  • Experience working with French pharmacovigilance processes and local affiliates.
  • Exposure to audits or inspections is an advantage.

Responsabilités

  • Support the Local QPPV in compliance with EU pharmacovigilance legislation.
  • Act on behalf of the Local QPPV during absences.
  • Support oversight of PV vendors, partners, and distributors in France.

Connaissances

Pharmacovigilance experience
Knowledge of EU PV requirements
Experience with French regulations
Ability to manage safety cases

Formation

Degree in Life Sciences, Pharmacy, Medicine, Nursing
Description du poste
Deputy Local Qualified Person for Pharmacovigilance Apsida Life Science•Paris, FR

Job Title: Deputy Local QPPV

Location: France - remote-based

Duration: 12 months contract

Company Overview:

Apsida Life Science is currently partnering with a preclinical biotechnology company which focuses on innovative protein therapeutics derived from a naturally occurring human anti-inflammatory protein. Its proprietary protein fragment retains key therapeutic functions while offering enhanced stability and manufacturability.

Responsibilities:
  • Support to Local QPPV & Regulatory Compliance
  • Support the Local QPPV in maintaining compliance with EU pharmacovigilance legislation and French PV regulations.
  • Act on behalf of the Local QPPV during planned or unplanned absences, ensuring uninterrupted PV coverage.
  • Support interactions with the French competent authority (ANSM), including responses to regulatory requests, inspections, and audits.
  • Escalate safety concerns, compliance issues, and significant deviations promptly to the Local QPPV and EU QPPV.
  • Support oversight of PV vendors, partners, and distributors operating in France.
  • Safety Case Management & Reporting
Qualifications:
  • Degree in Life Sciences, Pharmacy, Medicine, Nursing, or a related scientific field
  • Minimum 2–4 years of pharmacovigilance experience, preferably including EU PV requirements
  • Experience working with French pharmacovigilance processes and local affiliates or distributors
  • Exposure to audits or inspections is an advantage

If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science:

Sweetness.zono@apsida.com

+44 7441 342281

www.apsida.co.uk

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