Votre mission

QRVI Team Management

Management of the local QRVI team: direct coordination and supervision of all local Q/R/V/I activities, organizational improvements, people’s skills and expertise development

Regulatory Affairs

• Take responsibility for all regulatory activities for PFM & PFDC of PFA in accordance with local legislation in force

• Supports the business in NZ in providing regulatory assistance to the local partner(s) and regulatory input/expertise to Corporate projects

• Manages Regulatory intelligence for all types of products: anticipates, assess and communicate any legislative changes in Australia/NZ that may affect our products to reduce the business impact

Quality Management

• Develop, implement and manage a Quality Management System according GxP’s and Corporate requirements for all activities for PFM and PFDC of PFA in accordance with the Australian legislation in force

• 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, and in coordination with local Medical Director for PFM.

Pharmaco / Cosmeto Vigilance

• Coordinates and organizes, at the national/area level and in liaison with the Corporate Vigilances Direction (CVD), all activities in relation with 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 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

• 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

• Provides safety related information to global teams for the preparation of Aggregate Reports, when necessary

• Ensures local signal detection activities and communicate to Corporate any potential local safety signal detected during the routine vigilance activities

• Ensures the implementation and maintenance of a Vigilances Quality System in the affiliate in accordance with Corporate processes and local regulatory authority requirements

• Participates to the negotiation and writing of local vigilance agreement with local partners or services

 

Profil recherché

• Degree in Medicine, Pharmacy or life science

• Successful previous job experience (7-10 years) in QRVI in pharmaceutical and/or cosmetic industry

• Significant experience in Safety (especially, operational PV) + qualification per training and Over 2 (two) years’ experience in Pharmacovigilance

• 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

 

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

• Drug Safety knowledge

• 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 of result

• Quality and compliance oriented

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