Risk Evaluation Manager
Proclinical is currently recruiting for a Risk Evaluation Manager with a pharmaceutical company located in Foster City, CA.
- Utilize strong operational and project management skills to manage or provide support for the operational aspects of Risk Evaluation and Mitigation Strategies (REMS) programs
- Manage or provide support for ongoing REMS program commitments/department-wide initiatives by collaborating with key stakeholders including but not limited to, Regulatory, Global Patient Safety, Commercial, Medical Affairs, Legal, IT and external vendors
- May be responsible for internal and cross functional team representation and participate in cross functional projects as required including areas related to regulatory submissions for REMS programs per standard procedures
- Contribute to managing implementation related activities for REMS including but not limited to: website and print material verifications following FDA approval of an initial REMS or program modification to ensure compliance
- Assist with periodic training of REMS vendors and specialty pharmacies on adverse event (AE) reporting process and REMS-specific requirements to ensure REMS vendors adequately perform their contractual activities
- Ensure personal compliance with internal processes to meet all applicable internal/external reporting requirements for Global Patient Safety and REMS
- Support training and/or on-boarding activities, preparation and training materials for staff and vendors
- May support or manage activities related to solicited program management (e.g. Market Research, Patient Assistance Support Programs, and Digital Media), which can include training, reconciliation, and/or compliance monitoring
- Work with applicable teams within Global Patient Safety, other functions, or external vendors to implement and maintain activities or tasks under the remit of S&C
- Support cross-functional projects and may serve as a point of contact to other functions in the organization and outside the organization
- Understand and manage the execution of Global Patient Safety Business Continuity processes, as applicable
- Work in partnership with project leaders to ensure timely, efficient, and effective moderation of meetings, and to ensure adequate progress on team activities between meetings
- Co-Chair Project Team meetings and is responsible for coordinating moderately complex team operations and communications
- Direct project communications and ensures that all project customers are fully informed and knowledgeable of project activities and their status
- Organize Project Management support for various functional areas on the Project, attends sub-team meetings as necessary; organizes ad hoc working groups
- Ensure that Development Plans optimize the integration of timing, scope and resources
- Represent the Project Team or Working Group team to the Global Patient Safety Leadership or Program Steering Committee. Organizes preparation of moderately complex documents and/or procedures for review by the Global Patient Safety Leadership or Program Steering Committee for projects within Global Patient Safety
Skills and Requirements:
- 7+ years of relevant experience with BA/ BS
- 5+ years of relevant experience with MA/ MS
- A scientific background or experience in pharmacovigilance and/or REMS preferred
- Excellent interpersonal and communication skills, both written and oral
- Strong organizational skills and ability to adapt to changes
- Strong computer skills in Microsoft Excel, Word, and PowerPoint
- Experience in training delivery and project management preferred
- Experience with managing vendors, partners including specialty pharmacies, external PMO's highly preferred
- Excellence at resolving complex, interdependent activities into tasks and sub-tasks that are documented, monitored and controlled
If you are having difficulty in applying or if you have any questions, please contact Dominic Santoro at 215-531-5280.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.