MEDICAL INFORMATION AND QUALITY MANAGEMENT OFFICER

Job description

Entreprise:
Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world and the
2nd largest private French pharmaceutical group. In 2017, it generated 2,318
million euros in revenues, of which 62% came from its international business
and 62% from its dermo-cosmetics division. Pierre Fabre, which has always
been headquartered in the South-West of France, owns subsidiaries and
offices in 47 countries, enjoys distribution agreements in over 130 countries
and counts more than 13,500 employees worldwide.
Pierre Fabre’s portfolio represents a continuum of activities spanning from
prescription drugs and consumer health care products to dermo-cosmetics. In
2017, Pierre Fabre dedicated almost 143 million euros to R&D, shared
between oncology, the central nervous system, consumer health care,
dermatology and dermo-cosmetics.
Missions:
Based in Pierre Fabre Médicament's headquarters in the United Kingdom
(Reading, Berkshire), you will be asked to assist the local QiRVI Manager. You
will be asked to support the Quality and Medical Information functions of the
QiRVI Department in the activities listed below, which you shall undertake with
a commitment to patient and customer focus (internal and external) and in
compliance with our code of practice and the relevant legislation. Your activities
will encompass two main scopes: Quality Management System and Medical
Information. As such, your main missions will include:
Quality Management System
- Quality Risk Management (QRM);
- Deviations management related to Good Distribution Practice (GDP) (i.e:
temperature excursion);
- Change Control project involvement;
- Corrective Action and Preventive Action (CAPA) management;
- Associated Document Control in compliance with the relevant Global and
internal Quality processes;
- Customer Complaints investigation related to GDP;
- Management of Product Technical Complaints (PTC) for Pierre Fabre Ltd
portfolio in collaboration with Pierre Fabre Dermo Cosmetiques (PFDC) using
the Trackwise database;
- Identification and reporting of Safety information to the Pharmacovigilance
and Cosmetovigilance Department;
- Reviewing the Quality Complaints SOP in compliance with the relevant Global
and internal Quality processes;
- Preparation of monthly Quality reports and key performance indicators (KPIs).
Medical Information
- Maintenance of disease state, therapeutic area and product information
covering the Pierre Fabre Ltd portfolio of Prescription Only Medicines (POM)
and Medical Devices;
- Management and tracking of Medical Information enquiries using the internal
database;
- Provision of relevant medical information responses in a timely manner;
- Development of standard responses and frequently asked questions (FAQs);
- Identification and reporting of safety information and product technical
complaints to the appropriate departments;
- Preparation of monthly Medical Information reports and key performance
indicators (KPIs);
- Conducting literature searches for cross-functional teams covering medical,
scientific and regulatory information;
- Managing the ordering and tracking of publication requests from the British
Lending Library (BLL);
- Copyright Legislation application;
- Associated Document Control in compliance with the relevant Global and
internal Quality processes.
Profil:
A Pharmacist or life science first degree or equivalent (at least 5 years of
higher education)
Excellent English language proficiency in both written and verbal
communication (job is in English)
Strong time management skills and the ability to be self–sufficient and
resourceful.
Computer literacy – Microsoft Office.
Commitment to customer focus in all aspects of the role.