Responsible for maintaining and managing a highly skilled, stable and functional in house monitoring team to meet the developing needs of the Global Oncology business and developing and rolling out new monitoring processes and work instructions to best implement consistency and efficiencies.
- Lead the PV activities for studies within assigned programs, including program safety reviews for SAE / AE reporting, SAE reconciliation, reviewing individual cases, and working with the vendors on outsourced PV activities.
- Work collaboratively with PV and cross-functional team members to manage the benefit/risk profile of assigned products and ensure patient safety.
- Assist in signal detection activities including data assembly, signal validation, and signal evaluation.
- Perform literature monitoring (with vendor support) and ensure appropriate sources are incorporated into signal detection activities.
- Participate in aggregate safety report activities including data compilation and analysis as well as writing of assigned sections (with vendor support.)
- Compile agenda, data, slides, and minutes in collaboration with Program Safety Lead for cross-functional Safety Management Team meetings.
- Engage with team and support all activities required for presentation to the SDP Oncology cross-functional, senior level, Oncology Safety Committee.
- Represent PV on cross-functional program and project teams; support PV Medical Safety activities on cross-functional program and project teams, as required.
- Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with Program Safety Lead, including communication with internal and cross-functional team members, submission of data requests, and compilation of analysis and results.
- Develop Standard Operating Procedures, Work Instructions, and other controlled documents for PV Operations and Medical processes.
- Contribute to internal departmental and/or cross-functional inspection readiness and operational improvement activities.
- Serve as a subject matter expert in Pharmacovigilance, including operations and medical, within the assigned program as well as the larger R&D and Commercial organization.
- Support collaboration with external partners.
- Other duties as assigned.
- Bachelor’s degree in nursing, pharmacy, or other life sciences required. Master’s degree, preferred.
- Minimum 7 years of Drug Safety and Pharmacovigilance experience.
- Vendor management experience.
- Knowledge of FDA, ICH, EU Regulations and Requirements for Pharmacovigilance required.
- Experience using Argus, ArisG, or other Safety Database applications.
- Oncology experience preferred.
Job Location: Cambridge, MA
Equal Opportunity Employer
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