QRVI Manager

Job description

Who we are ?

Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.

Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive, Pierre Fabre Oral Care. 

Established in the Occitanie region since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. 86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation, a government-recognized public-interest foundation, while a smaller share is owned by its employees via an employee stock ownership plan. 

In 2019, Ecocert Environment assessed the Group’s corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the “Excellence” level.

Pierre Fabre is recognized as one of the "World's Best Employers 2021" by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide. 

Your mission

1.GENERAL MISSION OF THE POSITION

Direction of all local QRVI operations and management of the team (coordination and supervision, resources and budget, local networking activities, reporting to Coiporate QRVI... )

Management direction, organisation and assessment of all operational Q/RN II activities (expertise in all 4 activities must be demonstrated), with an immediate priority to Quality and Vigilance, according to the Corporate guidelines / SOPs; risk assessment and management at all levels of the subsidiary.

This general assignment covers all local products regardless of their status and legal entity (MC, DCPC)

2.MAIN MISSIONS

 

2.1QRVI Team Management:

·  Management of the local QRVI team: coordination and supervision of local QRVI activities, organizational improvements, people's skills and expertise development, incl. continuous training,
·  Be involved in local QRVIjob descriptions drafting, in yearly appraisals of local QRVI staff
·  Manage on a daily basis any cross-functional activity related to QRVI activities and risk management Ensuring cross-functional effectiveness and optimal networking at the local and corporate levels.
·  Supervise and pilot closely local thirds parties with whom certain Q R V or MI activities may be subcontracted.
·  Ensure that all the key QRVI activities are performed and achieved according to Corporate guidelines and within the allotted time. Ensure adherence to Good Practices.
·  Ensure that the Quality Management System (QMS) is developed appropriately and in time
·  Ensure appropriate and reliable audits and CAPAs follow up.
·  Act as the local contact person for QRVI activities in case of critical issues and /or local crisis management, in close partnership with the Corporate and local GMs.
·  Coordinate at the local level interactions with local HAs, in close collaboration with the Corporate and GM.
·  Facilitate any local corporate mission (ie: audits, meetings with HAs or stakeholders... ).
·  Be involved in the budget process for local QRVI activity. Ensure appropriate local coordination of the local QRVI budget, in close partnership with the corporate.
·  Attend meetings, phone and video conferences organized by the Corporate on a regular basis or upon request.
·  Ensure regular reporting of activity through pre-defined metrics previously validated by the Coiporate.
·  Ensure regular reporting of relevant key performance indicators (K.Pls) to the Corporate.
·  To ensure regular monitoring oflocal legislation regarding QRVI topic, analysis of impact on local QRVI activities.
·  Take over res ponsibility of direct o perational QRVI activities accordin g to related job  descriptions and SOPs

2.2.Quality Management:

·  Acts as a local QP for medicinal products managed locally by PFDC. Obtaining and maintenance of GDP certificate for local PDFC activities.
·  Assist local General Management with regard to compliance with quality-related regulations.
·  Coordinate quality activities and guarantee the quality and compliance of processes for the entire scope of the position, including subcontractors.  •
·  Establish and manage documentation on current practices by ensuring that practices fulfill requirements and implementing updates and/or systematization.
·  For all these missions, act as the interface with head office and subcontractors in the context of the application of relevant directives (guidelines, procedures, etc.) and in the context of exceptional situations, such as non-compliance, recalJs, withdrawals, etc.
·  Supervise the management of claims related to Pierre Fabre Group finished products and propose corrective actions.
·  Provide sufficient technicity to all operations/missions conducted within the department: this provides us with credibility in our contacts with authorities and/or partners.
·  Prepare and ensure the follow-up of audits (internal, customer, supplier, subcontractors, authorities, etc.) in the context of the obtaining and maintenance of the certifications required for the Subsidiary's activities.
·  Put in place appropriate quality indicators. Ensure regular reporting of relevant key perfonnance indicators (KPls) to the Corporate (at least on a monthly basis).
·  Develop, implement and manage a Quality Management System according GxP's and Corporate requirements for all activities for MC and DCPC, dealing with Drugs, Medical Devices, Cosmetics, biocides and Food supplements of PF Affiliate in the Czech Republic in accordance with the Czech and Slovak legislation in force.
·  Ensures accurate communication and coordination with the Corporate Quality Department.
·  Refer to Corporate guidelines and local SOP (if needed), for any question potentially related toQRVI.
·  Ensure that the Quality Management System (QMS) is in use for all local quality processes.

2.3 Regulatory Affairs:

·  Supervision local Q&RA manager, setting priorities, ensuring all local RA activities are performed in line with business strategy set by a local GM and Corporate needs.
·  Takes responsibility for all regulatory activities for PFM & PFDC dealing with Drugs, Medical Devices, Cosmetics, biocides and Food supplements, when appropriate, of PF Affiliate in the Czech Republic in accordance with local legislation in force.
·  Supports the business in providing regulatory assistance to the local partner(s) and regulatory input/expertise to Corporate projects.
·  Provides functional regulatory support in new TG development being manufactured by a third party.
·  Ensures accurate communication and coordination with the Corporate Regulatory Affairs and is supportive in all marketing regulatory activity in accordance with the Czech and Slovak legislation in force.
·  Ensures management of Regulatory intelligence for all types of products: anticipates, assess and communicate any legislative changes in the country that may affect the products, to reduce the business impact.
·  Represents interest in local trade associations and share information with internal stakeholders.

·  Is responsible for Regulatory compliance oversight and Database management (RIM)

2.4    Pharmaco/Cosmeto Vigilances:

·  Supervision of a local Vigilances Manager/ LSO. Setting priorities and solving issues out of scope of a local Vigilances Manager.
·  Acts as Back-up LSO

2.5  Local Scientific and Medical Information specific:

·  Supervises and /or takes over the responsibility of local medical and scientific information (LMSI) activities of all MC & DCPC marketed products (including compassionate/name patient basis uses}, according to the Corporate guidelines/SOPs and local SOPs {if appropriate, especially when local requirements are more demanding) and in coordination with local Medical Director for MC.
·  Set up the system capture of the requests coming from physicians, pharmacists, patient or consumers locally, identify the flow of the demands to ensure that the requests are collected and answered. Set up generic e-mail address, generic phone number... as needed.
·  Ensure continuity of vigilances and medical and scientific information activities at the local level, including the set-up of a system to cover out of business hours.
·  Ensure appropriate coordination is in place with the following functional activities: QA, medical, clinica1, regulatory activity, marketing, legal, sales representatives, regional directors, and any other local function which needs support from or which activity has an impact on scientific and medical information).

2.6 Ethics and Compliance and GDPR specific:

 
·  Supervision of Local Ethics & Compliance Officer {LECO) for Ethics &Compliance and  GDPR agenda.
·  Setting priorities and solving issues out of scope of LECO.

3.CONTEXT AND CHALLENGES OF THE POSITION

General Context

·  Reports directly to GM of local subsidiary, acts under functional responsibility of Corporate QRVI Director.
·  Cross- functional position requiring continuous partnership and good coordination with all subsidiary's functions, Corporate QRVI, local HAs and local third parties.
·  Support all the Group's activities that are subject to constantly changing external constraints
·  Take part in reinforcement of compliance, lead to the prevention of risks for the subsidiary and the Group.
·  Appropriate organization, good management skills, responsibility sense and autonomy are required.
·  Responsible for abiding by the Corporate guidelines and local SOPs {if needed).
·  Ability in networking.
·  Is authorized to communicate on behalf of PF with local HAs and bodies, industry associations, etc.

Legal and regulatory context and challenges:

·  Product safety
·  Phannaceutical legislation and regulations (international and local) and related legislation and regulations (cosmetics, medical devices, etc.)
·  The safety of individuals.
·  The risk of non-conformity in all agendas, including EC and GDPR (penalties, withdrawals, etc.).
·  Subject to constantly changing external constraints.

Internal Context

·  Diversification of products regulatory status and therapeutical claims, management of various activities imply solid scientific background, know-how, strategic approach and vision.

Key Relationships (excluding direct line management) Key Relationships may include but are not limited to:

·  Quality, Regulatory, Vigilances (with EU QQPV), Medical Information corporate teams
·  Local Regulatory affairs
·  Local Medical Affairs
·  Local Clinical Operations
·  Local Medical information
·  Local Quality
·  LocalMarketing
·  Local Legal
·  External PartnersNendors

4.FIGURES

·  Types of activities {distribution, commercialization, manufacturing/repackaging, etc.)
·  Number and types of products (medicines, medical devices, food supplements, cosmetics)
·  Subsidiary sales
·  Number of subcontractors / outsourced activities
·  Number of signed SDEA and QA Agreements
·  Compliance / KPI
·  Number of audits /inspections / CAPA
·  Number of trainings
·  Number of Medical questions solved / answered
·  Number of quality claims / deviations
·  Feedback

5. TRAINING, EXPERIENCE, NECESSARY SKILLS

 

Education:

Degree in medicine, veterinary medicine, phannacy or life science. Continuous education in the field (selfstudy, internal and external trainings)

Experience:

·  Successful previous job experience (7-10 years) in phannaceutical industry, especially in QRVI activities. Experience in cosmetic industry would be appreciated.
·  Knowledge of Quality references and practical experience in the implementation and operations of a Quality Department
·  Previous experience of contacts with local HAs is required.
·  Solid knowledge in the field of health law and legislation
·  Significant experience in Safety (especially, operational PV) + qualification per training and Over 2 (two) years' experience in Phannacovigilance
·  Demonstrated success in defining and implementing SOP at a local level are mandatory:
·  Training or previous successful experience in risk management or equivalent is mandatory.

Required skills:

·  General context: Cross- functional position requiring continuous partnership and good coordination with Corporate and local third parties; Take part in reinforcement of compliance and risk management; Responsible for abiding by the Corporate guidelines and local SOPs; Ability in networking; Highly skilled in management; responsibilities sense and autonomy are required
·  Competencies
·  Leadership and management skills Organization and planning skills Communication skills
·  Fluent English language knowledge, written and verbal Influencing skills
·  Proven ability to interact well in a multifunctional team setting Knowledge
·  Drug Safety knowledge
·  Drug Safety relevant regulations (ICH, EMEA, FDA - if relevant - and local RA) Medical terminology in English - verbal and written
·  Behavioural skills:
·  Rigour, analysis and synthesis capabilities Adaptability, anticipation
·  Personal assertion, management skills
·  Open-mindedness, team spirit, communication with corporate entities Sense ofresult
·  Quality and compliance oriented
·  Languages:
·  English: written and spoken
·  Czech and/or Slovak: written and spoken

Who you are ?

We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.