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 develop and deliver empowering medicines for women’s health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission.
We are currently seeking a qualified, highly motivated, experienced individual for the position of Senior Manager, Pharmacovigilance Quality and Compliance. The position reports to the Director, Pharmacovigilance Quality and Compliance. The location of the position is in Brisbane, CA.
The Senior Manager, Pharmacovigilance Quality and Compliance manages, maintains, and ensures compliance with the pharmacovigilance quality management system, including but not limited to policies, procedures, manuals, training, surveillance and key performance metrics. The Senior Manager assists in overseeing the quality of work performed by contract service providers responsible for pharmacovigilance services and partner and contract service provider compliance with pharmacovigilance agreements and safety management plans, respectively. The Senior Manager supports the department and Myovant Quality in preparing for and managing audits and inspections involving the pharmacovigilance system.
Essential Duties and Responsibilities
- Participation with senior management to establish strategic plans and objectives;
- Monitors and trends Drug Safety and Pharmacovigilance performance indicators;
- Contributes to key compliance reports for senior management;
- Collaborates with Quality on corrective action and preventative actions relevant to pharmacovigilance including but not limited to documentation of quality review findings, root cause analysis, trend analysis, implementation of process improvement measures, and effectiveness checks;
- Contributes to inspection readiness activities;
- Supports the conduct of audits and inspections involving the Drug Safety department, closely collaborating with Quality in the preparation, review and approval of the audit agendas and reports;
- Ensures functional lines prepare and maintain processes to support a quality pharmacovigilance system;
- Contributes to standard operating procedures relevant to pharmacovigilance;
- Contributes to the maintenance of the pharmacovigilance system master file;
- Identify gaps in the pharmacovigilance system and implement solutions;
- Assist with other Safety department activities as needed.
Core Competencies, Knowledge, and Skill Requirements
- Knowledge of current US and international pharmacovigilance regulations
- Effective time management and organization skills
- Ability to multi-task under limited direction and on own initiative
- Good interpersonal, written and verbal communication skills
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
- Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
- Daily demonstrates a positive, ‘can do’ and service oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Skilled in developing collaborative internal and external relationships.
- Required skill in the operation of standard office equipment including: fax machines, copy machines and other equipment as necessary.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
- Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees.
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
- Minimum Bachelor's degree required preferably in healthcare or life sciences.
- Minimum of 7 years relevant industry experience, which includes at least 5 years of pharmacovigilance and compliance experience, global setting preferred.
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.
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Equal Employment Opportunity