Deputy Local Qualified Person for Pharmacovigilance

Apsida Life Science; Lyon; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A biotechnology company is seeking a candidate to support the Local QPPV and ensure regulatory compliance in France. The ideal candidate will have 2-4 years of pharmacovigilance experience, particularly with EU regulations and French processes. Responsibilities include supporting safety case management and reporting, as well as interacting with the competent authority. This role offers an excellent opportunity to contribute to biopharmaceutical safety and compliance within a dynamic team.

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 to Local QPPV & Regulatory Compliance.
• Act on behalf of the Local QPPV during absences.
• Support interactions with the French competent authority.
• Escalate safety concerns and compliance issues promptly.
• Support oversight of PV vendors, partners, and distributors.

Connaissances

Pharmacovigilance experience

Knowledge of EU PV requirements

Understanding of French pharmacovigilance processes

Communication skills

Formation

Degree in Life Sciences, Pharmacy, Medicine or related field

Description du poste

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:

[e-mail]

[phone]

www.apsida.co.uk