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/ Associate Director, Pharmacovigilance Operations. The position reports to the Director, Pharmacovigilance Operations. The location of the position is in Brisbane, CA.
The Senior Manager/ Associate Director, Pharmacovigilance Operations will oversee aggregate report production by contract service providers and manage internal and external contributors and reviewers to ensure timely report distribution and submission. Maintain the aggregate report calendar for Myovant products. Additional responsibilities include managing safety management plans for assigned clinical studies, authoring Drug Safety and Pharmacovigilance standard operating procedures, and contributing to inspection readiness. Support and participate in cross-functional activities as a representative of Drug Safety and Pharmacovigilance.
Essential Duties and Responsibilities
- Oversee all aspects of aggregate report production;
- Serve as the subject matter expert for aggregate report management and review of agreements with partners and third parties concerning aggregate reports
- Participation with senior management to establish strategic plans and objectives;
- Develop and manage Safety Management Plans as necessary;
- Assist in developing, implementing and maintaining a quality system for pharmacovigilance; identify and follow-up on corrective action plans arising from audits and inspections;
- Assist with developing, implementing and maintaining standard operating procedures and policies relating to Pharmacovigilance and Risk Management to ensure compliance with ICH guidelines and all regulatory requirements;
- Develop and conduct training as necessary;
- Support pharmacovigilance audit activities.
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.
- Post-graduate degree (MD, PharmD, DO, RN)
- 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.
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