Global Safety Officer - Immunology & Inflammation

• Responsible for signal detection and analysis.

• Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group.

• Identify and implement proactive safety analysis strategies to further define the safety profile.

• Lead aggregate safety data review activities and coordinate safety surveillance activities.

• Signal detection and analysis.
• Development of safety action plans and implementation, as appropriate.

• Enable effective development of product safety.

• Enable appropriate risk management.

• Enable up-to-date risk communication (e.g. labeling).

• Provide proactive risk assessment.

• Co-lead benefit-risk assessment with other relevant functions.

• Develop risk management strategies and plans and monitor effectiveness.

• Collaborate with Center of Excellence for Risk Management and Safety Epidemiology.

• Optimization of the product benefit risk profile.

• Development of REMS, Risk Management and Development Risk Management plans.

• Identification and implementation of risk mitigation or other corrective actions as necessary.

• Regulatory compliance.

• Monitoring of risk mitigation tool effectiveness and adjustment of strategy, as needed.

• Represent safety position in cross functional submission teams.

• Ensure generation, consistency, and quality of safety sections in submission documents.

• Write responses or contributions to health authorities’ questions.

• Support preparation and conduct of Advisory Committee meetings.

Impact:

• Review, data analysis, preparation and/or contribution, and/or update of safety sections of relevant documents:

• For products under clinical development: Clinical Development Plan, study protocol, Statistical Analysis Plan, data monitoring plan, investigator brochure, Informed Consent Form, study report, Integrated Summary of Safety, Summary of Clinical Safety, risk management plan, label, periodic reports.
• For marketed products: Response to health authority question/request for information, Core Safety Information updates, periodic reports.

• Document, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report.
• Serve as the medical safety expert to the GPE Periodic Reports group for assigned projects and products.

• Regulatory Compliance.

• M.D. Degree or equivalent.

• For MD, Board Certified/Board eligible, or equivalent, is preferred.

• For M.D., minimum 3 years' total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience considered. Exceptionally, candidates may be considered if they have proven excellence in a similar prior position, even if they have less than 3 years international PV experience.

Knowledge and Skills:

• Excellent clinical judgment.

• Capability to synthesize and critically analyze data from multiple sources.

• Ability to communicate complex clinical issues and analysis orally and in writing.

• Able to develop and document sound risk assessment.

• Demonstrates initiative and capacity to work under pressure.

• Demonstrates leadership within cross-functional team environment.

• Excellent teamwork and interpersonal skills are required.

• Fluent in English (written and spoken).