Safety Signal lead / Safety Signal expert

Major accountabilities:

• 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   

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

Minimum Requirements: Medical Degree (MBBS or MD) required. Medical degree with specialization preferred.
Work Experience:

• 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.

Skills:

• Aggregate review
• Literature Review.
• Pharmacovigilance.
• Regulatory Compliance.
• Safety Science.

Languages :

• English.