managing and directing large multinational safety and medical information teams, dedicated to processing thousands of adverse events and medical information requests annually. Our focus on process quality provides your organization with high-quality safety processing and reporting - efficiently meeting your expectations and regulatory requirements.
Our safety teams of well-qualified healthcare professionals hold health science degrees and are experienced in safety report management activities. These teams continually undergo rigorous training and assessment to ensure that all best practice standards and client specifications are achieved.
A wide range of Sponsor companies outsource all or part of their case processing and reporting activities. Many large pharmaceutical companies are choosing to at least outsource, if not off-shore, the processing of their older and/or generic products in order to manage their business needs and re-focus their safety specialists into other related areas. IPM Safety Services can meet your needs with the provision of outsourced and off-shored solutions. Smaller pharmaceutical and biotech companies are seeing the opportunity for significant time and cost savings by outsourcing all of their processing activities – eliminating the need to build internal infrastructure by creating their own safety processes, teams and systems. IPM Safety Services works with clients to find the optimal solution for their needs – providing the opportunity for freed-up capital to be used in further developing the safety profile of their products.
Medical Information and Safety Call Center Services:
We offer an integrated medical information and drug safety service. Our 24x7, state-of-the-art Medical Information and Drug Safety Call Center handles medical information, product quality complaints, over-the-counter-product inquiries, and adverse event reports. By integrating the call center with the fulfillment of medical information requests and the processing of adverse events, clients are able to realize cost-efficient improvements in quality and timeliness and manage fluctuation workloads more easily.
- Medical information inquiry management
- Adverse event call intake and follow-up
Adverse Event Processing and Reporting:
IPM Safety Services professional staff provides complete or partial ICSR management for spontaneous or clinical trial adverse event case processing. We are experienced ARISg and Argus users and can work within your own safety database or provide you with our ARISg system. In addition to processing your clinical drug safety data, we’ll manage all of your pharmacovigilance needs for newly marketed drugs or take over legacy case entry and electronic data migration programs, as well as “rescue” failed safety programs.
IPM Safety Services works in partnership with our clients to create a strategy for managing pharmacovigilance operations. We work to achieve your business goals and provide the opportunity for measurable reduction in administrative overhead.
Case Receipt and Data Entry
- MedDRA and Who-Drug Dictionary Coding
- Narrative Writing
- Quality Control
- Medical Review
- Reporting to Health Authorities and Stakeholders
Development of Safety Reports:
IPM Safety Services offers a suite of drug safety services including the development of drug safety reports.
- Periodic Safety Update Reports (PSUR)
- Periodic Adverse Drug Experience
- Development Safety Update Reports (DSUR)
- Risk Management Plans
- Writing, Maintenance and Updates
- REMS Support
- Product Monitoring Activities
- Signal Detection, Analysis and Submission
- Line Listing Review
- Ad hoc
- Issue Management
- Tracking through Mitigation
- Communication with Client and External Experts
- Leadership of/Participation in Product Review Committee
- Agenda Setting
- Action Item Tracking
A Seasoned Expert Leading IPM Safety Services
Angela Pitwood, Vice President, IPM Safety Services
Angela Pitwood is the Vice President of Pharmacovigilance for IPM Safety Services. Angela is responsible for the ongoing development and management of IPM Safety Services operations. With over 20 years of experience in the pharmaceutical industry, Angela offers her clients the assurance that their drug safety programs are being managed by a seasoned pharmacovigilance executive with experience in developing, implementing and leading safety operations in lower cost markets.
Angela was formerly Vice President of Drug Safety Surveillance at Pfizer, Inc., where she successfully developed and led 12 therapeutic area teams and support functions for the management of adverse event reporting for human health, including all phases of a product life cycle (drugs, vaccines and devices). Angela led these activities using a combination model of 360 in-house staff at three global locations – U.S., Europe and Asia. In addition, she developed and managed three off-shored safety processing vendor sites in India, as well as outsourced groups in the United States.