Director, Safety Evaluation and Risk Management
We are currently seeking a qualified, highly motivated, experienced individual for the position of Director, Safety Evaluation and Risk Management. The position reports to the Senior Vice President, Drug Safety and Pharmacovigilance. The location of the position is in Brisbane, CA.
The Director, Safety Evaluation and Risk Management is responsible for strategic medical leadership for global pharmacovigilance and risk management activities for Myovant product, investigational and marketed. This individual provides clinical expertise in the review and analysis of clinical study and postmarketing safety information. S/He will oversee signal management, including review of aggregate data, participate in the review of individual SAE reports, prepare pharmacovigilance commentary and analysis, and contribute to the preparation of safety evaluations in aggregate periodic reports.
The Director reports to the Head, Drug Safety and Pharmacovigilance, and represents the Drug Safety department in safety-related discussions with clinical development and postmarketing safety services vendors, and key internal stakeholders including Clinical Development and Early Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Quality Assurance, Commercial, Legal, & others who support ongoing clinical trials and overall lifecycle management, as well as Data Monitoring Committees and health authorities. The Director, Safety Evaluation and Risk Management contributes to the ongoing risk/benefit analysis of investigational drugs in clinical development and of marketed products.
This position may support one or more Myovant development programs and additional programs per business need, providing expert medical guidance regarding safety matters.
Essential Duties and Responsibilities
- Participation with senior management to establish strategic plans and objectives;
- Contribute to a full range of pharmacovigilance (PV) activities for investigational product and marketed products, including operational activities, cross-functional activities with other departments (e.g., Biometrics, Clinical Operations, Clinical Sciences, Regulatory, Sales & Marketing), quality systems, audits and inspections;
- Lead and oversee in the Signal Management System with regular review of safety data for assigned products for identification and evaluation of new safety signals
- Manage medical safety growht in ICSR review and assessment, including perform/provide oversight for medical review of individual safety reports from clinical trials or post-marketing sources;
- Contribute to preparation and review of periodic reports (PADER; PSUR; Annual IND report; 6-monthly line-listings; DSUR)
- Facilitate production and maintenance of risk management plans and safety communication (marketing applications, company core safety information, regulatory safety queries, etc.) to regulatory agencies or third parties
- Participate in protocol development to ensure alignment with risk management plans
- Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, SMC/IDMC Charters •
- Contribute to analysis of safety data from on-going and completed clinical trials and presentation in Clinical Study Reports
- Contribute to and review safety data exchange agreements with alliance partners and safety management documentation for studies managed under an alliance, as applicable
- Oversee preparation, development, implementation and maintenance of company standard operating procedures and policies relating to pharmacovigilance and risk management to ensure compliance with ICH guidelines and applicable regulatory requirements;
- Contribute to quality management plans and a compliance program; identify and follow-up on corrective action plans arising from audits and inspections;
- Participate in continuous improvement activities including systems design, performance measurement and quality management
- Support and manage inspection readiness for medical safety and risk management responsibilities.
- Maintain currency with applicable PV global regulations, and industry guidelines;
- Develop and conduct training as necessary;
- Provide regular performance feedback as well as development and coaching to direct reports.
Core Competencies, Knowledge, and Skill Requirements
- Healthcare professional with clinical practice experience
- Experience writing pharmaceutical or health-related documents
- Knowledge of current US and international regulatory requirements
- Experience using computerized systems (PC-Windows and MS Office)
- Excellent communication and interpersonal skills
- Interacts with Myovant employees, contractors and consultants.
- Post-graduate degree (MD, DO)
- Minimum of 10 years of relevant industry experience which includes at least 5 years of senior drug safety experience.
- Project leadership/management skills preferred
- Experience writing safety sections of marketing applications, integrated summary of safety, DSUR/PSUR preferred.
- Licenses or Certifications: board certification preferred
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
- Pharmaceutical medicine experience as listed in the requirements
TRAVEL, PHYSICAL DEMANDS, AND WORK ENVIRONMENT
- Regularly required to operate standard office equipment
- Ability to work on a computer for extended periods of time
- Regularly required to sit for long periods of time, and occasionally stand and walk
- Regularly required to use hands to operate computer and other office equipment
- Close vision required for computer usage
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
If you require any accommodations, please email email@example.com.
Equal Employment Opportunity