Manager/Senior Manager, Pharmacovigilance Operations
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.Summary Description
The Senior Manager, Pharmacovigilance Operations provides operational expertise and guidance to support Drug Safety department operations. The Senior Manager contributes to the development, implementation, and maintenance of a quality system for all Drug Safety department activities, encompassing processes, compliance, and metrics. The Senior Manager assists in overseeing Drug Safety service providers and coordinating communications and activities between Drug Safety and relevant Myovant service providers.
The Senior Manager reports to the Senior Director, Pharmacovigilance Operations and will be based in our Brisbane, CA office.
Essential Duties and Responsibilities
- Oversee and facilitate Drug Safety vendor activities, including safety database configuration (e.g., new studies, solicited programs), safety report form development, meeting minute management, and safety database data entry guideline maintenance.
- Maintain awareness of Drug Safety vendor’s SOPs with respect to contracted services and review changes to the vendor’s SOPs.
- Ensure Drug Safety preparedness for Myovant and partner-sponsored studies, solicited programs, business partners, investigator-initiated studies, and Myovant vendors that may be sources of safety data.
- Serve as the Drug Safety Operations primary point of contact for clinical study teams.
- Assist medical safety leads with clinical trial-related activities such as study team charter maintenance, informed consent review, protocol review.
- Serve as the department lead and oversee and manage Drug Safety Essential Documents to support TMF management.
- Support pharmacovigilance audits and inspections.
- Participation with senior management to establish strategic plans and objectives.
- Assist in maintaining a quality system for pharmacovigilance.
- Assist with developing, implementing and maintaining pharmacovigilance standard operating procedures to ensure compliance with ICH guidelines and regulatory requirements.
- Develop and conduct training as necessary;
- As applicable, provide regular performance feedback as well as development and coaching to direct reports.
- 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
- Experience writing pharmaceutical or health-related documents
- Knowledge of current US and international regulatory requirements
REQUIREMENTS (Education and Experience)
- Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline
- Minimum of 7+ years of relevant industry experience which includes at least 5+ years of drug safety experience.
- Project leadership/management skills
- Experience with Argus Safety preferred.
The well-being and safety of our employees is our top priority. Myovant Sciences requires all U.S. employees to be fully vaccinated against COVID-19 as a condition of employment regardless of location of role (field-based, fully remote or site-based). Fully vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. If you are unable to be vaccinated, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
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