Medical Safety Specialist [Innovative Medicine]

About Johnson & Johnson

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/ .

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.

Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.

Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve.

Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

We have a new and exciting opportunity to hire a Medical Safety Specialist for our Pharmacovigilance (Local Medical Safety) team at Hong Kong office!

Job Purpose and Scope:

Supporting that the LOC Safety activities, related to medicinal and non-medicinal products are managed in compliance with local regulations and company policies/procedures at a local, regional and global levels and in accordance with any Product vigilance agreements with third party business partners.

Having appropriate Pharmacovigilance and Risk Management systems in place to assure appropriate oversight for products within its responsibility.

Key Responsibilities:


* Support that systems and processes are available for collection and reporting of safety information to meet local and global requirements


* Maintain oversight on day-to-day AE inbound and outbound reporting as applicable


* Oversee data generating activities to ensure appropriate review and reporting process are included in project documents for reporting potential AEs (e.g.

patient support programs, market research surveys, internet sites)


* Ensure that day-to-day PV functions are performed satisfactorily, and that optimal regulatory compliance is maintained at the LOC level.


* Maintain overall responsibility for the coordination of safety requirements as delegated by Marketing Authorization Holders (MAH).


* Coordinate and support local PV audit and inspection.


* Ensure awareness of changes in regulations which may have an impact on vigilance activities and responsibilities.

Evaluate the impact on local processes and inform the appropriate global and regional groups...