337075BR
May 09, 2022
Spain

Job Description

More than 52 different medical diseases!

As our Medical Safety Lead within Oncology, you will help to get a important compounds to market safely in several areas of unmet medical need. You will also have the opportunity to present safety data to upper management.

Your Responsibilities Include, but are not limited to:

-Monitors the clinical safety of projects/products including activities such as literature review, evaluation of
individual cases or signal detection, and responds to safety-related questions appropriately.
-May deputize for the GPSL (in agreement with the project’s GPSL) or function as a GPSL for products to which no GPSL are assigned.
-Performs medical assessment and related activities for single cases whenever required, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of line listings of single cases, literature review and preparation of investigator notifications and periodic medical assessments for ethics committees. Of note: medical review of single case reports may need to be performed by Senior Medical Safety Leads as required according to business needs.
-Identifies safety signals based on the review of solicited or unsolicited single cases.
-Performs signal detection, monitoring and evaluation of all safety signals based on single cases and aggregate data using proper signal detection tools.
-Provides inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues.
-Prepares safety data for Health Authority review boards. -Provides input to responses for legal queries and Country Organization requests involving safety issues.
-Provides pharmacovigilance inputs to initial development and subsequent updates of core data sheet (CDS) and its related documents.
-May review and author submission documents (e.g. summary of clinical safety, clinical overview).
-Plays a significant role in the development and maintenance of Safety Profiling Plans (SPP) and Risk Management Plans (RMP) including the coordination with other line functions for associated activities such as updates, and the ongoing tracking of commitments and effectiveness measures.
-Provides guidance as appropriate to Clinical/PV Safety Operations for the coding and causality/expectedness assessment of adverse event reports

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you'll bring to the role:

* Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD in relevant field or Medical Degree (MBBS or MD) required. Medical degree with specialization preferred.

* Minimum of 6 years in drug development in a major pharmaceutical company.

* 4 years in patient safety at an operational or medical position (or equivalent experience) is desirable.

* Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications.

* Proven ability to analyze, interpret, discuss, and present safety information both in writing and orally.

* Experience in preparing or contributing to preparation of clinical safety assessments.

* Experience with (safety or others) issue management

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Global Drug Development
CMO & PATIENT SAFETY GDD
Spain
Barcelona
Research & Development
Full Time
Regular
No
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337075BR

Senior Medical Safety Lead

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