[Innovative Medicine] PV Specialist

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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Product Safety

Job Sub Function:
Pharmacovigilance

Job Category:
Scientific/Technology

All Job Posting Locations:
Seoul, Korea, Republic of

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

The Specialist, Local Medical Safety, Korea (PV Specialist), is responsible for managing day-to-day pharmacovigilance (PV) activities in compliance with local regulations and company policies and procedures at the local, regional, and global levels.

The role also supports local medical safety activities to ensure proactive benefit-risk management throughout the product lifecycle.

Key Responsibilities

ICSR MANAGEMENT AND OVERSIGHT


* Ensure local collection, review, reporting, reconciliation, and follow up on Individual Case Safety Reports (ICSR).


* Manage and maintain active involvement in day-to-day ICSR management related activities as applicable.


* Ensure implementation of local literature process.


* Maintain oversight of corresponding vendor activities as required.

COMPLIANCE ACTIVITIES


* Ensure PV audit/inspection readiness at the LOC level at all times.


* Maintain oversight of ICSR inbound and outbound compliance.


* Increase PV compliance awareness and business relevance with stakeholders and ensure appropriate ownership of PV-related findings and Corrective Action/Preventive Actions (CAPAs).


* Escalate compliance issues in a timely manner to Country/Cluster Safety Head (CSH), to ensure appropriate mitigation is implemented.


* Address follow-up actions from Local Safety unit (LSU) owned non conformances, including LSU related CAPAs

AGGREGATE REPORTING


* Review, translate (if applicable), prepare, submit and track aggregate reports as required by local regulations and ensure ...