Experienced Specialist Local Medical Safety

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:
Milano, Italy

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

We are searching for the best talent for an Experienced Specialist Local Medical Safety to be in Milan.

Purpose

We ensure that the local Pharmacovigilance (PV) system is handled 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.

We support activities related to the pharmacovigilance regulatory requirements of Marketing Authorization Holders (MAH) and/or study sponsors, as applicable.

You will

Ensure the management of the local Pharmacovigilance (PV) system as described and in accordance with any PV agreements with third party business partners.

Ensure pro-active Benefit Risk Management throughout product life cycle by translating global safety data to insights and actions, and tailoring to local specificities and needs.

Conducting local benefit-risk activities to ensure pro-active benefit-risk management

Icsrs's management and oversight

Ensuring local collection, review, reporting, reconciliation, and follow up of Individual Case Safety Reports (ICSR) and implementation of the local literature process.

Maintain active involvement in day-to-day ICSR management related activities and maintain oversight of corresponding vendor activities as required.

Aggregate reports

Leading Preparation, review, tracking and timely submission of aggregate reports to all relevant local authorities or other official bodies, where applicable.

Local Safety compliance

Providing insights into ICSR inbound and outbound compliance metrics, perform ICSR reconciliations and leading actions as needed.

Acting as a CAPA content owner and subject matter authority, owning actions as required.

Performing or coordinating procedural document review and improvement, conducting impact assessments as required on l...