Safety Signal Expert

NOVARTIS

4 - 9 years

30 - 35 Lacs

mumbai

Posted:9 hours ago| Platform:

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Skills Required

hira risk assessment iso hazard identification construction safety fire safety accident investigation industrial safety ehs safety management safety training safety safety audit construction safety inspection hse safety officer activities

Work Mode

Work from Office

Job Type

Full Time

Job Description

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,
Lea d t h e t r a inin g a n d m e n t o ri n g 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

Key performance indicators:

Timeliness and quality of safety analyses, interpretations, and presentations
Compliance with internal and external regulations and procedures.
Ability to work effectively within a metrics organization

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