Area Safety Head, France

Johnson & Johnson is currently recruiting a/an **Area Safety Head (France, French speaking territories, Spain and Southern Europe), Local Safety Organization**. This position is located in France (Issy les Moulineaux)

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products, and services to advance the health and well-being of people.

With $82.1 billion in 2020 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen. Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer. Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

Your mission : Ensuring that the Local Operating Company (LOC) Safety activities for the area (France, French speaking territories, Spain and Southern Europe) related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional and global level and in accordance with any Product vigilance agreements with third party business partners

Act as the Local Operating Company (LOC)’s and assigned territories’ (as applicable) main contact point for PV matters with the local Health Authority.

Having appropriate product vigilance and risk management systems in place in order to assure appropriate oversight for products within its responsibility.

The Area Safety Head will:
Provide Line-Management and/or oversight (vendor resource) in the area collaborative network.

Maintain up-to-date knowledge of local requirements for PV, including reporting requirements (for all applicable product classes in the territory); collaborate with global team to implement process changes required on identification of new requirements

Maintain oversight on day-to-day AE inbound and outbound reporting as applicable in the given territory

Receive and support the responses to safety-related Health Authority queries in the territory

Collaborate with global and local teams to notify local Health Authorities of any safety issues including SSI/ESI and signals

Provide relevant local information for the EEA/UK PSMFs; collaborate with global team to meet requirements for local PSMF if applicable

Collaborate with local and global teams to ensure PV compliance of local company sponsored programs and research activities

Ensure provision of information to global teams for local activities compliance with individual cases and periodic safety reporting, implementation of risk management plans; key performance indicators related to overseeing local implementation of any other specific risk management activities

Supporting local Health Authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with global team to develop and implement CAPA plans as applicable

Recording self-identified non-conformances and collaborating with global team to investigate non-conformances and develop and implement effective CAPA

Maintain local procedures where applicable, assess impact of changes to global procedure to local procedures

Ensure current knowledge on all relevant company procedures and training and ensure document management and archiving

**Qualifications**
Position Requirements

6-8 years relevant experience

Pharmaceutical industry experience including product vigilance responsibility role is required.

Sound knowledge of general medicine or pharmacy and clinical practice, or relevant scientific/medical field.

Proven ability to organize workflow activities and manage multiple critical issues.

Awareness of and familiarity with industry principles of product vigilance, drug development and pharmacology.

Expert knowledge of Global, Regional and Local Procedural Documents as applicable.

Computer literate with knowledge of relevant IT safety systems.

Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers.

Ability to establish and maintain open relationships within the organization and with authorities.

Demonstrable knowledge of all local requirements and