Local Medical Safety Specialist

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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

Job Function:
Product Safety

Job Sub Function:
Pharmacovigilance

Job Category:
Scientific/Technology

All Job Posting Locations:
TR011 J&J Ertürk Sokak Keçeli Plaza İstanbul

Job Description:

Johnson & Johnson is recruiting for Local Medical Safety Specialist  to be located in Istanbul, Turkey.

  

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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/.  

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

The employee is part of the Johnson & Johnson Innovative Medicine Office of the Chief Medical Officer (JJIM OCMO).

Essential Job Duties and Responsibilities


* Ensure that the local Pharmacovigilance (PV) system is managed in compliance with local regulations and company policies/procedures at local, regional, and global levels and in accordance with any PV agreements with third party business partners.

Task may include:


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


* Ensure implementation of local literature process.


* Maintain oversight of corresponding vendor activities as required.


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


* Maintain oversight of ICSR inbound and outbound compliance.


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


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


* Ensure awareness of new/changes in local PV regulations and evaluation of the impact on local/global processes and notification of appropriate local, regional and global groups.


* Engage in local industry associations and drive local policy shaping initiatives based on One J&J Voice.


* Ensure that...