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 every day 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.

Purpose/Objective of the job

  • To ensure consistent and effective standards are established and maintained, both at a local and global level, thereby ensuring integrity and compliance of the Corporate PV function. Oversight of the conduct of PV functions and activities within around 60 countries (Legal Entities and distributors), to ensure consistency and fulfillment of regulatory responsibilities. Have oversight of International PV legislative changes and ensure Operational aspects in the International organization are carried out (PV Excellence).
  • Negotiation, update, and maintenance of all Pharmacovigilance Agreements (PVAs).
  • Creation and maintenance of global PV process documents including UPSA PV Global Procedural document.
  • Development and continued update of training materials (internal and external).

🧾What are the main responsibilities of the position?

  • Oversight and strategic leadership for all Local Markets (including Distributor markets) PV activities (case intake, OLU evaluation, ICSR submission to the local HAs, aggregate reports/RMP submission to the local HAs, local PV intelligence) ensuring that appropriate standards and process are maintained to meet respective regulatory and internal requirements.
  • Ensure the efficient and effective deployment of Global programs and initiatives at the local level.
  • Evaluate, optimize, develops and integrate processes, systems and policies as they relate to International PV.
  • Ensures inspection readiness plans are in place and that any inspection issues/findings are addressed adequately.
  • Ensures effective communication of issues relating to product safety.
  • Ensures effective, strong and productive relationships and working interfaces between PV and other functions.
  • Reviews the business agreement and provides the appropriate pharmacovigilance wording. Based on the business
    agreement terms and applicable regulatory requirements evaluates the need for a PVA. If a PVA is required, draft, negotiates, and execute a PVA with the Partner.
  • Develop policies and interpret regulations in support of PV activities and obligations.
  • Develop and maintain of all PV procedural documents, including UPSA PV Global Procedural document.
  • Ensure that necessary processes and measures are in place and that PV is inspection-ready at all times.
  • Ensure that the PV training program is robust and supports PV personnel and, where applicable, personnel external to PV, and provides the relevant training and education required for their roles. Provide support for training activities.
  • Back Up activities in Global PV, particularly for PV Scientist.
  • Take in charge simplified safety aggregate reports under the supervision of the HGPV

What skills/experiences are expected for the role?

  • Nurse/MS/PharmD, or equivalent with relevant scientific experience and/or training discipline
  • Minimum 3 years MS/PharmD, or equivalent relevant Pharmaceutical Industry experience;
  • Experience of remote management and oversight, within a matrix environment, safety and medical related matters for UPSA products.
  • Full knowledge of international, regional and country-specific regulations and guidelines pertinent to drug safety and PV.
  • Ability to establish or consolidate internal networks with other regional stakeholders to ensure compliance.
  • Oversee or lead regulatory PV inspections, either at the local country level or at the regional level.
  • Excellent communication skills, both written and oral (French and English).
  • IT driving skills including computer systems used for PV system.

🍀 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.