Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer designed to improve the lives of millions. We are on a mission to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We are looking for passionate and enthusiastic individuals who share our excitement for this mission.
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director, Pharmacovigilance Alliance Management located at our Brisbane office. The position is responsible for managing pharmacovigilance-related work with Myovant contractual partners, vendors responsible for safety data collection, and internal functional lines. The Associate Director, Pharmacovigilance Alliance Management, has a leadership role in the development, implementation and maintenance of pharmacovigilance agreements (PVA), review of third-party contracts involving safety data collection responsibilities and management of pharmacovigilance-related activities specified in the PVA, such as collaborating with medical staff to coordinate safety review meetings. This position reports to the Senior Director, Pharmacovigilance Operations.
Essential Duties and Responsibilities
- Participation with senior management to establish strategic plans and objectives
- Lead and support pharmacovigilance activities associated with PVAs, investigator-sponsored studies, solicited commercial or medical programs and related cross-functional activities with other departments
- Develop, maintain and revise PVAs
- Review and revise contracts with safety data collection activities
- Support functional lines as needed in developing post marketing solicited programs to ensure appropriate safety data collection processes are planned
- Assist in developing, implementing and maintaining a quality system for pharmacovigilance; follow-up on corrective action plans arising from audits and inspections
- Assist with compliance activities as they relate to pharmacovigilance-related agreements and partners/vendors or Myovant functional lines
- Assist with the developing, implementing and maintaining standard operating procedures and policies relating to Pharmacovigilance
- Develop and conduct training as necessary
- Support pharmacovigilance audit activities
- Provide regular performance feedback as well as development and coaching to direct reports as applicable.
- Experience writing pharmaceutical or health-related documents
- Knowledge of current relevant US and international regulatory requirements
- Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
- Exercise good judgment and make decision that is appropriate for the organization
- Results-driven, take initiative and ownership to accomplish work
- Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
- Strive for continuous improvement and embrace innovative ideas in daily work
REQUIREMENTS (Education and Experience)
- Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline
- Minimum 10+ years of relevant experience in biotech or pharmaceutical industry including at least 4 years of experience managing PVAs
- Excellent project leadership/management skills
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.
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Equal Employment Opportunity