Drug Safety Operations Manager
2 weeks ago
Location: Mississauga, Canada
Job reference: R-190091
Date posted: 01/23/2024
**Fixed Term Contract Role**: This is a 1 year fixed term contract role.
**This is what you will do**:
The Drug Safety Operations Manager is responsible for 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 for larger and/or more complex projects. The Manager also plays a key role within Global Drug Safety to ensure proper case management of Alexion investigational products adverse event case reports.
The incumbent will provide scientific, compliance, and safety database expertise as needed to GDS and other Alexion groups according to Alexion GDS standards and processes in partnership with the Director, Global Drug Safety Operations, and others as appropriate
**You will be responsible for**:
- Represent GDS as a member of Global development and post approval core team’s subcommittee & teams
- Collaborate with other departments and vendors to ensure data collection, analysis and reporting in Alexion interventional trials and Early Access Programs (EAP) follows global regulatory requirements and Alexion/AZ 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 EAP.
- 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
- Collaborates with Clinical Operations, Data Management, Clinical CRO and Study Teams in development of the safety related data collection forms and safety reporting plans (SRP), leading Global Drug Safety aspects of these deliverables
- 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, leading Global Drug Safety aspects of these deliverables
- 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
**You will need to have**:
- 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 clinical trials, patient programs, market research programs)
- Case processing experience with PV safety databases; Oracle Argus experience preferred.
- Strong people and project leadership skills
- Strong organizational and prioritization skill
- Strong analytical, negotiation, and problem-solving skills
- Strong communication skills, oral and written, including medical / scientific writing
- 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
**We would prefer for you to have**:
- 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
**Hybrid Work Model**: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office (Located in Mississauga at QEW and Cawthra). But that doesn’t mean we’re not fl
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