Safety Signal Lead

Job Description

1200! That’s the number of highly committed associates in CMO & Patient Safety focusing on protecting patients’ safety and improving patients’ lives through increasing the benefit-risk profile of our medicines and medical safety innovation.

Your responsibilities include, but are not limited to:

• Lead the safety signal detection and triage activities for a challenging product portfolio. Identify new safety signals early based on review and comprehensive medical evaluation of technical hits in postmarketing spontaneous reporting databases analyzing single case reports as well as aggregate data available
• Provide expert evaluation of results of postmarketing signal detection activities at cross-functional team meetings: Product Safety Team, SMT/SMB, Joint Safety Committees as appropriate.
• Collaborate productively with the safety leads for the respective products and, as a core member of the cross-functional SMT, provide expert input for postmarketing signal detection activities using internal and external spontaneous reporting databases.
• Provide expert input to MSRB presentations to safety team and Global Head of Safety Signal Detection. Perform database searches in external Health Authority databases (FAERS/ Vigibase), analyzing and reporting the results.
• Perform QC checks of Health Authority database searches done by colleagues. Provide relevant inputs for enhancements of current systems and processes; Provide safety input as it relates to postmarketing signal detection activities to safety documents, as well as ad hoc Health Authority queries.
• Act as Subject Matter Expert (SME) for postmarketing Safety Signal Detection (including participation in initiatives) and provide guidance on methodology used for automated signal detection to safety leads and cross-functional SMT/SMB.
• Manage Eudravigilance database requests i.e. monitoring Eudravigilance for assigned products; Lead the training and mentoring of junior Safety Signal Colleagues and take an active part at the medical safety onboarding activities.
• Drive the development and update of Business Guidance documents and SOPs accordingly; Contribute to the development of new approaches of automated signal detection in internal/ external databases.

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

• Medical Degree (MBBS or MD) required. Medical degree with specialization preferred. Fluency in English is prerequisite, while knowledge of other in-scope country languages would be an advantage
• Relevant experience (e.g., clinical, postdoctoral) after graduation. At least 4 years in drug development in a major pharmaceutical company, including 2 years in patient safety at an operational or medical position (or equivalent experience) is desirable.
• Experience in Quantitative Safety Signal Detection and Safety Signal Management related activities
• 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 safety assessments and regulatory reports involving safety information
• Experience with (safety or others) issue management.

WHY NOVARTIS

769 million lives were touched by Novartis medicines in 2020, 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.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network