The Manager GDS Operations – Case Management is responsible for Argus Case Processing of Individual Case Safety Reports from Alexion Sponsored Clinical Trials in the Global Safety Data Base, ensuring accurate and timely submissions of SUSARS and other SAE reports.
Other responsibilities include the oversight and implementation of Drug Safety Operational activities within Global Drug Safety, Study Management Teams, Clinical Operations, and other internal Alexion departments regarding the development of Alexion investigational and marketed products. The Manager plays a key role within Global Drug Safety to ensure proper case management of Alexion investigational and marketed products adverse event case reports.
The incumbent will provide scientific, compliance, and safety database expertise as needed to GDS and other ALXN groups according to Alexion GDS standards and processes.
Job Duties & Responsibilities
Responsibilities for this role include, but are not limited to:
- Individual Case Safety Report processing, ownership and management from case receipt to lock for Alexion sponsored studies.
- Represent GDS as a member of Global development and post approval core team’s subcommittee & teams
- Collaborates with other Alexion departments and vendors to ensure data collection, analysis and reporting in Alexion interventional, non‐interventional trials and IIT/ISR is in compliance with global regulatory requirements and Alexion SOPs
- Serves as an expert on pharmacovigilance global regulations, guidelines and industry best practices
- Ensures compliance with health authority regulations with regards to data collection, analysis, reporting standards and operational consistency across interventional and non‐ interventional trials
- Collaborates with other members of the Case Management and other Operations groups to ensure critical or missing case information for appropriate medical assessment is obtained.
- Works with CROs and clinical teams to ensure design of all trials enables timely processing and global regulatory compliance for all SAEs from assigned protocols
- Participates in SAE reconciliation activities between the clinical and safety databases in accordance with Alexion SOPs
- Collaborates with Clinical Operations, Data Management, Clinical CRO and Study Teams in development of the safety related data collection forms, table design, and listings for safety data from interventional/non‐interventional trials and safety reporting plans (SRP)
- Ensures compliance with clinical trial activities as outlined in SRP and protocol and that proper documents are in place for monitoring
- Ensures compliance and quality are maintained and issues are escalated appropriately and resolved
- Participates in product team, client and investigator meetings as requested or needed
- Participates in and contributes to the continuous process improvement efforts and standardization of pharmacovigilance processes and methods
- Assists with the creation and documentation of pharmacovigilance training and conventions
- Assists with the execution of CAPAS to minimize compliance gaps with the remit of role and responsibility
- Performs other duties related to the position as necessary as defined in SOPS and/or as request by Supervisor
- Serve as a SME for pre and post approval inspection for the studies/products under their responsibility
- Supports HA Inspections and internal audit activities.
- Demonstrated proficiency in global regulatory requirements, guidelines and industry best practices for pharmacovigilance with experience in safety related organized data collection, analysis and reporting (e.g., interventional and non‐interventional clinical trials, registries, patient programs, market research programs)
- Case processing experience with PV safety databases; Oracle Argus experience preferred.
- Experience in MedDRA coding and search strategies
- Strong people and project leadership skills
- Strong organizational and prioritization skill
- Strong analytical, negotiation, and problem solving sills
- Strong communication skills, oral and written, including medical / scientific writing
- Presentation skills for conveying complex technical contents to non‐expert audience
- Demonstrated commitment to quality and compliance
- Demonstrated learning agility and ability to work independently, seeking advice as required
- Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis
- Expertise with Microsoft Word, PowerPoint, SharePoint and Excel
- Understanding of clinical development processes related to clinical trials required
- Bachelor’s degree required; Health care degree preferred (RN, RPh, PharmD)
- Minimum of 5 years' pharmaceutical experience, with at least 2 years in drug safety operations
- Advanced understanding of medical concepts and terminology
- Demonstrated knowledge of global aspects of pharmacovigilance
- Experience in medical writing
- Excellent attention to detail
- Excellent oral and written communication skills
- Analytic and strategic thinking in complex multi-cultural situations