Area Safety Lead UAE/gulf, Local Safety

1 week ago

Dubai, United Arab Emirates Johnson & Johnson Full time

Johnson & Johnson is currently recruiting an Area Safety Lead UAE/Gulf, Local Safety (New Consumer Health Company). This position is located in Dubai.

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.

**Role & Responsibilities**:
Ensure that the Local Operating Company Safety activities for the Middle East & Gulf Countries, in relation 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’ main contact point for Pharmacovigilance (PV) matters with the local Health Authority.

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

**Key Responsibilities**:

- Provide oversight of vendor resources 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 the global team to implement process changes needed with the identification of new requirements
- Maintain oversight on day-to-day adverse event 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 Significant Safety Issues/Emerging Safety Issues and signals
- Provide relevant local information for the EEA/UK Pharmacovigilance System Master File (PSMF) and collaborate with the 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, 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 Corrective and Preventive Action (CAPA) plans as applicable
- Record self-identified non-conformances and collaborate with the global team to investigate non-conformances and develop and implement effective CAPA
- Maintain local procedures where applicable and assess the impact of changes to the global procedure to local procedures
- Ensure current knowledge on all relevant company procedures and training and ensure document management and archiving

**Qualifications**
- A minimum of 3 years of relevant experience
- Pharmaceutical industry experience including a product vigilance responsibility role
- Sound knowledge of general medicine or pharmacy and clinical practice, or a relevant scientific/medical field
- Experience with vendor resource oversight
- 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
- Must be computer literate with knowledge of relevant IT safety systems
- Excellent verbal and written communication skills with a proven ability to negotiate and communicate with internal and external customers
- Ability to establish and maintain open relationships wi

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