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.

Your mission

Quality Team Management:

·  Manages the local QRVI team: direct coordination and supervision of all local Q/R/V/I activities, organizational improvements, people’s skills, and expertise development,
·  Be involved in local QRVI job descriptions drafting, in yearly appraisals of local QRVI staff.
·  Ensures cross-functional effectiveness and optimal networking at the local and corporate levels.
·  Ensures appropriate definition, coordination, and follow-up of the local QRVI budget, in close partnership with the corporate
·  Ensures that all the key QRVI activities are performed and achieved according to corporate guidelines and within the allotted time.
·  Ensures regular reporting of activity through pre-defined metrics previously validated by the Corporate
·  Manage daily any cross-functional activity related to QRVI and risk management.
·  Supervises closely local thirds parties with whom certain Q R V or MI activities may be subcontracted.

Regulatory Affairs:

·  Takes responsibility for all regulatory activities for PFM & PFDC dealing with Therapeutic Goods (TG), prescription Drugs, Medical Devices, Cosmetics, biocides, and Food supplements, when appropriate, of PFVN in accordance with local legislation in force
·  Supports the business in Vietnam 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 Vietnam legislation in force.
·  Manages Regulatory intelligence for all types of products anticipates, assess, and communicate any legislative changes in Vietnam that may affect our products to reduce the business impact.
·  Represents interest in local trade associations and share information with internal stakeholders.
·  Be responsible for Regulatory compliance oversight and Databases management.

Pharmacovigilance and Safety Monitoring:

·  Develop, implement, and manage a Quality Management System according GxP’s and Corporate requirements for all activities for PFM and PFDC dealing with OTC drugs, prescription Drugs, Medical Devices, Cosmetics, biocides, and Food supplements of PFVN in accordance with the Vietnam legislation in force.
·  Ensures accurate communication and coordination with the Corporate Quality Department
·  Ensure regular reporting of relevant key performance indicators (KPIs) to the Corporate (at least monthly)
·  Refer to corporate guidelines and local SOP (if needed), for any question potentially related to QRVI.
·  Ensure that the Quality Management System (QMS) is in use for all local quality processes.

Medical Information

·  Supervises and /or takes over the responsibility of local medical and scientific information (LMSI) activities of all PFM, PFD, and PFDC 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 Pierre Fabre Medicament.

Pharmaco/Cosmeto Vigilance:

5.1. Pharmaco/Cosmeto Vigilance

·  Coordinates and organizes, at the national/area level and in liaison with the Corporate Vigilances Direction (CVD), all activities in relation to the oversight on the safety profile of the portfolio.
·  Management of Vigilances Cases whatever the status of the product and the sources.
·  Oversight of Risk Management Plan (RMP) Implementation (medicinal products only)
·  Ensures oversight of RMP implementation in collaboration with relevant staff in accordance with CVD and local regulatory authority requirements.

5.2. Safety Communication

·  Ensures that safety queries, other significant safety issues and, if applicable, local/global crisis management are performed according to corporate processes and local regulatory authority requirements.
·  Maintains oversight of any safety communication to Healthcare Professionals or consumers as applicable
·  Provides EU QPPV office with all relevant information to allow their oversight and follow up on requests from the EU QPPV office as applicable (medicinal products only).
·  Acts as nominated person (or local QP) for local competent authority if and as required by local regulations.
·  Keeps up to date with local regulations.

5.3. Study and Program Oversight

·  Ensures appropriate safety reporting processes are in place at affiliate level and, if applicable, described in relevant local documents, for global and local interventional clinical trials, Non- Interventional Studies (NISs), Non-Interventional Programs (NIPs) and Compassionate Use in accordance with corporate processes and local regulatory authority requirements.

5.4. Management of Aggregate Reports

·  Provides safety related information to global teams for the preparation of Aggregate Reports, when necessary.
·  Ensures the writing of Aggregate Reports for local products, when applicable, in collaboration with Local Regulatory Affairs.
·  Ensures submission of Aggregate Reports (as applicable) to local regulatory authorities in accordance with global processes and local regulatory authority requirements.

5.5. Signal Detection

·  Ensures local signal detection activities and communicates to Corporate any potential local safety signal detected during the routine vigilance activities.
·  Ensures the writing Signal Detection Reports for local medicinal products, when applicable, in collaboration with CVD (medicinal products only)
·  Ensures oversight of the corporate summary tabular of safety signals. (medicinal products only)

5.6. Vigilances Quality System

·  Ensures the implementation and maintenance of a Vigilances Quality System in the affiliate in accordance with corporate processes and local regulatory authority requirements.
·  Assumes responsibility for educating and training relevant personnel in the affiliate.

5.7. Local Vigilances Agreement

·  Participates in the negotiation and writing of local vigilance agreements with local partners or services providers.
·  Informs the Corporate Vigilances International Unit before hands on all contracts that are set up locally regarding vigilances activities and/or which have an impact on vigilances activities (any contract with a partner company for subcontracting of specific vigilances activities).
·  Ensures compliance with agreements.
·  On a timely manner, provides feedback to the Corporate Vigilances International Unit on all changes the LSO is aware of (e.g.: change in products concerned by the vigilances agreement).

5.8. Labelling and Commitments

·  Ensures awareness and contributes (as applicable) to local safety label updates.
·  Contributes to the implementation of commitments, when applicable

5.9. Management of the local Vigilances unit (staff and activities) as applicable

·  Leads a team of motivated individuals and promotes Vigilances standards across the organization.
·  Ensures Vigilances activities are properly resourced.

5.10. Business continuity

·  Ensures continuity of vigilances and medical information activities at the local level, including the set-up of a system to cover out of business hours.

Ethic and Compliance Referent

In close cooperation with the Regional Compliance Officer:

·  Manages day-to-day operation of the Ethics & Compliance Program and provides guidance and advice to management and employees,
·  Locally monitors any Ethics & Compliance campaign as directed by the Corporate Ethics and Compliance Department,
·  As necessary, coordinates Ethics & Compliance activities of other departments such as Human Resources and Legal ones, to remain abreast of the status and trends of such activities,
·  Identifies potential areas of non-compliance risks, of potential vulnerability, develops and implements corrective/preventive inherent action plans, and provides the management with general guidance and advice on how to avoid or deal with similar situations in the future,
·  Institutes and maintains an effective Ethics & Compliance communication program for the staff, such as (a) promoting use of the Alert System as laid down in the Group’s Code of Ethics; (b) heightening awareness of standards of conduct, (c) understanding of new and existing compliance issues and (d) promoting internal control best practices.
·  Works with both the Human Resources Department and the Group Ethics & Compliance Department to develop an effective Ethics & Compliance training program, including appropriate initial training for newcomers as well as ongoing training for all employees and managers.
·  Monitors the local performance of the Ethics & Compliance Program and related activities, on a continuing basis, taking appropriate steps to improve its effectiveness.
·  Communicates on the evolution of codes, regulations, and laws in terms of Ethics and Compliance and thus facilitates the implementation of a robust system.

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.