Head Global Risk Management, Vaccines応募 Job ID R0004991 Location Cambridge, Massachusetts, United States; Zurich, Canton of Zurich, Switzerland;
- Responsible for developing and ensuring execution of all GVSE safety risk management activities within agreed time frames and to a high standard of accuracy, in compliance with Takeda’s business rules, standard operating procedures and global and local regulatory requirements.
- This will include pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks relating to compounds in development and marketed products including the assessment of the effectiveness of those activities and interventions
- Responsible for development and postmarketing risk management plans (RMPs) that are in alignment with the company's drug development and commercialization strategies
- Lead internal cross functional RMP teams (which include representatives from Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, etc) and champion risk management safety strategy to external stakeholders (eg, regulators and commercial collaborators)
- Ensure local and global risk management plan (RMP) preparation and execution throughout a medicinal product’s life-cycle. Coordinate RMP activities with external vendors, as applicable
- Support Vaccine Safety leads on signal detection for VBU’s portfolio of investigational and marketed products for identification and management of safety signals and their inclusion in RMP strategies & risk minimization measures (as applicable)
- Participate significantly in the development and production of integrated summaries of safety, clinical overviews, and other registration documents for new and supplemental NDAs and/or ex-US new drug submissions for late-phase drug development candidates and marketed products in conjunction with Clinical Development, Medical Writing, Statistics, and Regulatory Affairs.
- Perform activities required to serve as VBU PV representative as outlined in applicable Takeda quality management system documents (e.g. Procedures, Job Aids). This includes
- Prepares, with support from cross functions, ad hoc responses to regulatory authorities in response to specific queries from regulators.
- Provides input into responses to inquiries from internal sources, health care professionals, and other external sources.
- Provides support as required for licensing activities, regulatory authority inspections, company audits, and for project product recall activities.
- Performs pharmacovigilance training and mentoring of internal and cross-functional team members.
- Participates as a safety expert in Clinical Trial Teams, Clinical Development Teams, DMC meetings, Investigator meetings, as applicable.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES & SKILLS:
- Medical Degree (MD)
- Vaccines and/or biotechnology industry experience preferred
- Minimum 8 years of experience in clinical trials and postmarketing pharmacovigilance
- Minimum 5 years of pharmaceutical and/or biotechnology industry experience in Pharmacovigilance functioning as a senior Pharmacovigilance Physician.
- Minimum 5 years of experience in RMP management, signal detection and evaluation
- Strong investigational event and aggregate assessment/review/documentation skills.
- Strong working knowledge of US/EU/APAC regulations and ICH guidelines.
- Strong experience in risk management plan preparation and review, including European Union Risk Management Plans (EU - RMPs) and US REMS.
- Experience in communicating with the FDA, EMA, and other global health authorities.
- Sound working knowledge of MedDRA coding.
- Understanding of pharmacovigilance-related information systems.
- Oversight of the pharmacovigilance and risk management strategy with responsibility for the medical safety content of all documents required to implement and monitor the progress of risk management plans and for responses to ad hoc safety issues to regulatory authorities.
- Expert in Aggregate Report preparation and review.
- Proven collaborative internal relations with Clinical Development, Regulatory Affairs, Medical Affairs, Quality and Legal Counsel.
- High integrity, sense of urgency, ability to recognize time sensitivity, willingness to be a "player/coach".
- Excellent English written and verbal communication skills, additional languages (e.g., Spanish, Japanese, German) desired.
- Dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging circumstances.
- Demonstrated success in building effective matrix working teams, systems, and processes; proven ability to identify, select and manage a variety of external resources.
- Leadership/managerial experience preferred.
- Requires approximately 20% travel, including overnight and international travel
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