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:
High Wycombe, Buckinghamshire, United Kingdom

Job Description:

Purpose

Local Medical Safety (LMS) ensures 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.

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

Please note that this role is available with the same job title, but different levels of experience.

While you are welcome to apply to any or all of the postings, we recommend focusing on the experience that aligns with your profile.

2+ years of experience - R-020042

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

You will be responsible for:

Ensuring 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.

Conducting local benefit-risk activities to ensure pro-active benefit-risk management throughout the product life cycle.

ICSR 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 as applicable, 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 expert, owning actions as required.

Performing or overseeing procedural document review and improvement, conducting impact assessments as required on local level and support implementation of Global PV relevant documents as applicable.

Responsible for timely provision of high quality and accurate contributions to PSMF, as required.
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