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This is a remote position.
Major Duties & Responsibilities:
Internal & External Safety Expert:
Provide PV and risk management expertise to internal and external customers.
Safety expert for product.
Maintain knowledge of product, product environment, and recent literature.
Maintain PV expertise, and understanding of international safety regulations and guidelines.
Lead cross functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs).
Communicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations.
Provide strategic and proactive safety input into development plans.
Support due diligence activities and pharmacovigilance agreements.
Impact:
Ongoing assessment of the safety status of the product.
Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling.
Review, preparation, and/or contribution to questions from health authorities, ethics committees, IRBs, external partners.
Management of product safety alerts.
Ensuring the GPE position is well articulated to and understood by its internal and external customers.
Establishment of credibility of GSO function and of GPE.
Signal Detection and Assessment: 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.
Impact:
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).
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.
Impact: 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.
Submission Activities: 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.
Serve as the medical safety expert to the GPE Periodic Reports group for assigned projects and products.
Impact: Regulatory Compliance.
Basic Qualifications: 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.