Address 393753BR
Senior Safety Signal Expert
India
About the role
Job Purpose
Performs Safety Signal detection and triage activities for assigned post-marketing products using internal and external spontaneous reporting databases. Assist in providing input to safety documents, as well as ad hoc Health Authority queries as it relates to automated signal detection. Provide support to the Safety Leads by creating quality deliverables within agreed timeframes and adhering to a high standard of accuracy in compliance with Patient Safety business rules, standard operating procedures and global and local regulatory requirements.
Your responsibilities include, but are not limited to:
Performs Safety Signal detection and triage activities for assigned post-marketing products using internal and external spontaneous reporting databases. Assist in providing input to safety documents, as well as ad hoc Health Authority queries as it relates to automated signal detection. Provide support to the Safety Leads by creating quality deliverables within agreed timeframes and adhering to a high standard of accuracy in compliance with Patient Safety business rules, standard operating procedures and global and local regulatory requirements.
Your responsibilities include, but are not limited to:
- Perform Safety Signal detection and triage activities for the assigned product portfolio.
- Work closely with the safety leads for the respective products and support them in monitoring the safety profile of products by performing postmarketing signal detection activities using internal and external spontaneous reporting databases.
- Provide medical evaluation of technical hits in Empirica for assigned products adhering to current processes and timelines. Perform a cumulative assessment at first time occurrence of a hit. Focus on new cases/ Cases with significant follow up information at re-occurrence of a hit.
- Perform signal triage and provide Empirica review results to safety leads within assigned timeframe.
- Present and discuss results of postmarketing signal detection activities at Product Safety Team, SMT/SMB, Joint Safety Committees as appropriate.
- Provide input to MSRB presentations to safety team/ Global Head of Safety Signal Detection.
- Act as a core member of the SMT and support the safety leads on safety management related topics particularly Health Authority database (FAERS/Vigibase/Eudravigilance) related queries
- 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.
- Assist in providing safety input to safety documents, as well as ad hoc Health Authority queries as it relates to postmarketing signal detection activities (e.g. input from Eudravigilance data to PSURs).
- Act as Subject Matter Expert (SME) for postmarketing Safety Signal Detection (participation in initiatives). Monitor the Eudravigilance database for assigned products, if required.
- Mentors newly recruited junior colleagues by supporting their integration into the Safety Signal Expert role.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
Minimum Requirement
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!
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
- Medical Degree (MBBS or MD) required. Medical degree with specialization preferred.
- 3+ years of PV, Medical practice or Clinical Drug Development experience post MBBS.
- Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries.
- Excellent understanding of ICH GCP , GVP guidelines and medical terminology.
- Attention to detail and quality focused. Strong organizational and project management skills. Strong negotiation and communication skills, and the ability to operate effectively in an international environment
- Excellent understanding of Human physiology, pharmacology, clinical study objectives, and the drug development process
- Strong technical understanding of Biomedical/Biostatics concepts and problem solving skills
- Good presentation skills
- Strong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety databases/applications.
- Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability.
- Ability to mentor, and coach within Patient Safety and cross functionally.
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!
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
Division
Development
Business Unit
Patient Safety & Pharmacovigilance
Work Location
Hyderabad, AP
Company/Legal Entity
Nov Hltcr Shared Services Ind
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
