Johnson & Johnson is currently recruiting for an Area Safety Head France, Local Safety (New Consumer Health Company). This position will be located in Haute-de-Seine, France.
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.
Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company.The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals.
It is anticipated that, following conclusion of the transaction, this position may be conveyed with New Consumer Health. In that case, details of any planned changes would be provided to the successful candidate by New Consumer Health at an appropriate time and would be subject to any necessary consultation processes.
Job Description:
The Area Safety Head France, Local Safety will be responsible for 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. They will act as the Local Operating Company (LOC)’s and assigned territories’ (as applicable) main contact point for pharmacovigilance matters with the local Health Authority. They will also be responsible for having appropriate product vigilance and risk management systems in place in order to assure appropriate oversight for products within its responsibility.
Roles and Responsibilities:
- Providing line management and/or oversight of vendor resources in the area of the collaborative network
- Maintaining up-to-date knowledge of local requirements for PV, including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for the identification of new requirements
- Maintaining the oversight on day-to-day adverse events inbound and outbound reporting as applicable in the given territory
- Receiving and supporting the responses to safety-related Health Authority queries in the territory
- Collaborating with the global and local teams to notify local Health Authorities of any safety issues including SSI/ESI and signals
- Providing relevant local information for the European Economic Area/UK Pharmacovigilance System Master Files and collaborating with the global team to meet requirements for local PSMF if applicable
- Collaborating with the local and global teams to ensure PV compliance of local company-sponsored programs and research activities
- Ensuring the provision of information to the global teams for local activities compliance with individual cases and periodic safety reporting, implementation of risk management plans, and key performance indicators related to overseeing the 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 the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable
- Recording self-identified non-conformances and collaborating with the global team to investigate non-conformances and develop and implement effective CAPAs
- Maintaining local procedures where applicable and assessing the impact of the changes to the global procedure to local procedures
- Ensuring current knowledge of all relevant company procedures
- Training and ensuring document management and archiving
Qualifications
Position Requirements:
- 6-8 years of relevant experience
- Pharmaceutical industry experience including product vigilance responsibility role is required
- Sound knowledge of general medicine, pharmacy, clinical practice, or another relevant scientific/medical field
- Experience as a line manager and vendor resource oversight
- Proven ability to organize workflow activities and manage multiple critical issues
- Awareness 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
- 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 global aspects of product safety
- Fluency in the national language(s) and the English language is required
Source ⇲
