Pharmacovigilance Expert / Deputy EU QPPV (M/W)

The UPSA laboratories (Union de Pharmacologie Scientifique Appliquée) are historically specialized in pain management and self-medication. Doctor Camille Bru founded the laboratories in Agen in 1935.

In the last eight decades, UPSA has developed an unparalleled expertise in Europe in relation to pain, flu conditions, energy, digestion, and quality of sleep. UPSA symbolizes research, quality of excellence and French production: thanks to its extensive self-medication product range, UPSA develops and introduces new medication to treat everyday pains.

UPSA is part of Taisho Pharmaceutical group since July 2019.

Since 1951, UPSA’s manufacturing plant was built in Agen, in the department of Lot-et-Garonne (47). UPSA is constantly seeking innovative ways to address health’s permanent evolution. In that regard, UPSA capitalizes on its center for development pharmaceutics to adapt to its patients’ changing needs.

What are the main responsibilities of the position?

Back-up of EU QPPV

• Fulfill the duties of the EU QPPV as per Directive 2010/84/EU-Article 104 and Good Vigilance Practice Module, in case of EU QPPV absence.
• Be informed of all EU QPPV activities to be able to act as back-up during planned or unplanned absences of the EU QPPV.

Signal Management

• Establish and lead Safety Management Team (SMT) for UPSA products.
• Conduct proactive signal detection and signal assessment activities using all available relevant data and tools, escalation to Safety Issue Assessment Committee (SIAC) as needed as per SMT/SIAC charters.
• Propose labeling recommendations based on proactive signal detection activities.

Safety Aggregate Reports

• Perform safety data analyses, develop conclusions, and supervise writing of safety aggregate reports.

Risk Management

• Develop and implement risk management plans strategy according to the most current regulatory guidelines.
• Write the risk management plans and supervise interactions with internal UPSA’s contributors.
• Conduct discussion and answer questions related to risk management plans with Health Authorities.

What skills/experiences are expected for the role?

• Degree: PharmD/MD.
• While the specific experience requirement will depend on the demonstrated achievements of the individual, prior experience of minimum 7 years in pharmacovigilance practice in the pharmaceutical industry is required and minimum 3 years of global safety experience is required.
• Excellent communication skills, both written and oral (French and English).
• Demonstrated ability to use safety databases.
• Demonstrated experience in safety reports (PSUR, Clinical Overview) and RMP redactions.
• Demonstrated experience in signal management processes.
• Additional knowledge in other vigilances (such as materiovigilance and nutrivigilance) is appreciated.
• Soft skills: teamwork, ability to improve and/or simplify existing processes, interactions with worldwide partners, lead during strategic meetings.

Joining UPSA means joining:

• An ambitious employer that nurtures its employees with opportunities.
• A young, dynamic, and passionate team focused on innovation, with a strong entrepreneurial spirit and a genuine sense of teamwork.
• Guidance and support from several complementary and caring managers.

Beyond the resume, we are seeking a personality passionate about their profession, challenges, and also about human connections.

UPSA is committed to responding to all applications for this position. UPSA guarantees fair treatment and equal opportunities in the applications and professional trajectories of its collaborators.

Diversity, inclusion, promotion of equal opportunities, and quality of work life are key focus areas of UPSA's policy. UPSA is convinced that diversity within the company is a true asset in the service of overall performance.