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 Director, Aggregate Safety Reporting located at our Brisbane or Basel office. The Director, Aggregate Safety Reporting leads the production of aggregate safety reports for investigational and marketed products. The Director is responsible for aggregate safety report management, including scheduling and planning, managing the contract service provider(s) and applicable partner(s) contributing to and reviewing the aggregate safety report(s), and ensuring report distribution to relevant stakeholders/parties to complete applicable submissions on time. The Director contributes to Drug Safety and Pharmacovigilance operations support, including management of standard operating procedures and department training as required. The Director contributes to the development, implementation and maintenance of a quality system for pharmacovigilance.
Essential Duties and Responsibilities
- Interacts and communicates effectively internally and cross-functionally in a highly matrix environment;
- Oversees the scheduling and preparation of aggregate safety reports for investigational and marketed products;
- Collaborates with internal stakeholders to ensure timely contributions and report review (Drug Safety medical lead, Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Commercial Operations, etc.);
- Collaborates with contractual partners in coordinating aggregate safety report responsibilities in accordance with the pharmacovigilance agreement;
- Provides strategic oversight of aggregate safety report service providers and manages both quality and compliance of assignments;
- Assists and supports activities related to the preparation of audits and inspections;
- Participates with senior management to establish strategic plans and objectives;
- Develops and manages Safety Management Plans as necessary;
- Assists in developing, implementing, and maintaining a quality system for pharmacovigilance;
- Identifies and follows up on corrective action plans arising from audits and inspections;
- Assists 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;
- Develops and conducts training as necessary;
- Provides regular performance feedback as well as development and coaching to direct reports as applicable.
- 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
- Demonstrate coaching skill to develop team
- Thought leader with track record to formulate and integrate functional strategies with corporate objectives and translate them into actionable deliverables.
- High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture
REQUIREMENTS (Education and Experience)
- Post-graduate degree (MD, PharmD, DO, RN).
- Minimum of 10 years of relevant industry experience which includes at least 8 years of drug safety experience.
- At least 3 years of experience managing aggregate report production.
- Project leadership/management skills.
- Experience with Argus Safety preferred.
- Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)
- 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.
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.
If you require any accommodations, please email firstname.lastname@example.org.
Equal Employment Opportunity