Area Safety Lead United Kingdom, Local Safety

Johnson & Johnson is currently recruiting for an Area Safety Lead United Kingdom, Local Safety (New Consumer Health Company). This position will be located in High Wycombe, England.

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.
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The Area Safety Lead United Kingdom, Local Safety will be responsible for ensuring that the Local Operating Company (LOC) Safety activities for the area (UK, Ireland, and Nordics) 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 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 oversight of vendor resources in the area collaborative network
- Maintaining up-to-date knowledge of local requirements for pharmacovigilance, 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 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 pharmacovigilance 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 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 changes to global procedure to local procedures
- Ensuring current knowledge of all relevant company procedures
- Training and ensuring document management and archiving

**Qualifications** Position Requirements**:

- 3-5 years of relevant experience
- Pharmaceutical industry experience including product vigilance responsibility role is required
- Sound knowledge of general medicine, pharmacy and clinical practice, or another relevant scientific/medical field
- Experience with 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 relevan