Drug Safety Operations Manager

2 weeks ago


Mississauga, Canada Alexion Pharmaceuticals,Inc. Full time

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



  • Mississauga, Canada Bayshore HealthCare Full time

    Drug Safety Compliance Team Lead is responsible for managing and overseeing the timely collection, processing, quality check and reporting of Safety events, ensuring compliance with Pharmacovigilance agreement (PVA), PV KPI monitoring and tracking as well as handling client inquiries. The incumbent will represent the Scientific Affairs Department at Bayshore...


  • Mississauga, Canada Bayshore HealthCare Full time

    **ABOUT THE ROLE**: The Drug Safety and Medical Information (DSMI) Coordinator is responsible for managing AE/PV inbox and supporting the collection, processing, quality check and reporting of Safety events (Adverse Events and/or Product Quality Complaints) and handling Medical Information (MI) inquiries. The incumbent will represent the Scientific Affairs...


  • Mississauga, Canada Bayshore HealthCare Full time

    **ABOUT THE ROLE**: The Bilingual Drug Safety and Medical Information (DSMI) Coordinator is responsible for managing AE/PV inbox and supporting the collection, processing, quality check and reporting of Safety events (Adverse Events and/or Product Quality Complaints), and handling Medical Information (MI) inquiries. The incumbent will represent the...


  • Mississauga, Canada Bayshore HealthCare Full time

    **ABOUT THE ROLE** The Drug Safety and Medical Information (DSMI) Coordinator (Floater) is responsible for managing AE/PV inbox and supporting the collection, processing, quality check and reporting of Safety events (Adverse Events and/or Product Quality Complaints), and handling Medical Information (MI) inquiries. The incumbent will represent the Scientific...


  • Mississauga, Canada Shoppers Drug Mart Pharmaprix Full time

    **Location**: 1685 Tech Avenue, Mississauga, Ontario, L4W 0A7 At Shoppers Drug Mart, we’re innovating health and wellness in Canada. From prescriptions to walk-in clinics, and a beloved loyalty program, we’re caring and supporting our customers in new ways every day. With more than 1,300 locally owned and operated stores from coast to coast, the...


  • Mississauga, Canada Shoppers Drug Mart Pharmaprix Full time

    **Location**: 5100 Erin Mills Pkwy, Mississauga, Ontario, L5M 4Z5 Join a locally owned and operated store to help deliver health, beauty and convenience services in your community, and keep the customer at the centre of everything you do. **Why this role is important?** **SUMMARY**: To assist the Front Store Manager (FSM) in managing the human, physical...


  • Mississauga, Canada Shoppers Drug Mart Pharmaprix Full time

    **Location**: 3052 Elmcreek Road, Building E, Unit 101, Mississauga, Ontario, L5B 0L3 Join a locally owned and operated store to help deliver health, beauty and convenience services in your community, and keep the customer at the centre of everything you do. **Why this role is important?** **SUMMARY**: To assist the Front Store Manager (FSM) in managing...

  • Manager, Health

    2 weeks ago


    Mississauga, Canada Cargojet Inc Full time

    Accelerate your career with the most awarded Air Cargo Airline in Canada!Cargojet is Canada's leading provider of time-sensitive overnight air cargo services and carries over 1,300,000 pounds of cargo each business night. Cargojet operates its network across North America each business night, utilizing a fleet of all-cargo aircraft Cargojet has been awarded...

  • Manager, Health

    1 week ago


    Mississauga, Canada Cargojet Inc Full time

    Accelerate your career with the most awarded Air Cargo Airline in Canada!Cargojet is Canada's leading provider of time-sensitive overnight air cargo services and carries over 1,300,000 pounds of cargo each business night. Cargojet operates its network across North America each business night, utilizing a fleet of all-cargo aircraft Cargojet has been awarded...

  • Manager, Health

    1 week ago


    Mississauga, Canada Cargojet Inc Full time

    Accelerate your career with the most awarded Air Cargo Airline in Canada!Cargojet is Canada's leading provider of time-sensitive overnight air cargo services and carries over 1,300,000 pounds of cargo each business night. Cargojet operates its network across North America each business night, utilizing a fleet of all-cargo aircraft Cargojet has been awarded...

  • Drug Product Technician

    Found in: Talent CA C2 - 1 week ago


    Mississauga, Canada Eurofins Full time

    Job Description The Drug Product Technician position in Drug Product Operations will be responsible for a variety of Drug Product specific activities related to GMP clinical manufacturing operations including but not limited to, GMP production of oral drug products, compression and powder handling equipment operation and compliance with GMP systems...

  • Operations Manager

    6 days ago


    Mississauga, Canada GFL Environmental Inc. Full time

    The Operations Manager will select, supervise and train employees in their respective position to ensure safe, professional and efficient service in branch with over 30 million in revenue. This individual will provide leadership which results in positive employee/employer relations and a professional corporate image. **Key Responsibilities**: Ensure fair...


  • Mississauga, Canada Shoppers Drug Mart Pharmaprix Full time

    **Location**: 1685 Tech Ave, Mississauga, Ontario, L4W 0A7 At Shoppers Drug Mart, we’re innovating health and wellness in Canada. From prescriptions to walk-in clinics, and a beloved loyalty program, we’re caring and supporting our customers in new ways every day. With more than 1,300 locally owned and operated stores from coast to coast, the Shoppers...

  • Manager, Health

    Found in: Jooble CA O C2 - 2 weeks ago


    Mississauga, ON, Canada Cargojet Inc Full time

    Accelerate your career with the most awarded Air Cargo Airline in Canada! Cargojet is Canada's leading provider of time-sensitive overnight air cargo services and carries over 1,300,000 pounds of cargo each business night. Cargojet operates its network across North America each business night, utilizing a fleet of all-cargo aircraft Cargojet has been...

  • Operations Manager

    14 hours ago


    Mississauga, Canada Poolcorp Full time

    **Location**:Mississauga, Ontario - 284, 4170 Sladeview Crescent, Unit 7, Mississauga, ON - L5L 0A1 **Looking to work for the best in the industry?** Look no further than POOLCORP, the world's leading distributor of outdoor living products. With over 420 Sales Centers in 13 countries and a team with more than 6,000 dedicated employees, we are committed to...


  • Mississauga, Canada AstraZeneca Full time

    **Locations**:Mississauga or Luton, UK At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of...

  • Manager Technical Operations

    Found in: Talent CA C2 - 2 weeks ago


    Mississauga, Canada Thermo Fisher Scientific Full time

    Manage the Process Engineering team and providesleadership and technical direction and guidance in the areas of manufacturing processes and technology, process improvement, quality performance for commercial batches, assistance in the pre-commercial lots run by Operations and technical support for the execution of Pharmaceutical Development Services (PDS)...

  • Senior Research Chemist

    Found in: Talent CA C2 - 1 week ago


    Mississauga, Canada Eurofins Full time

    Job Description The Sr. Research Chemist will be responsible for overseeing and executing analytical services in support of Drug Product development and GMP operations. Primary responsibilities will include analytical services such as method transfer, method development and phase appropriate method validation. The Sr. Research Chemist will also support...

  • Manager, Health

    3 days ago


    Mississauga, Canada Cargojet Airways Ltd. Full time

    **Accelerate your career with the most awarded Air Cargo Airline in Canada!** **Cargojet is Canada's leading provider of time-sensitive overnight air cargo services and carries over 1,300,000 pounds of cargo each business night. Cargojet operates its network across North America each business night, utilizing a fleet of all-cargo aircraft Cargojet has been...

  • Owner Operator

    3 days ago


    Mississauga, Canada C.A.T. Transport Full time

    **Passion for driving GTA Area, C.A.T Inc. is looking for Owner operator to drive Local Mississauga** **Hours a week: 40-60** Valid Class1 A/Z driver license is required Excellent driving record, no criminal record, negative drug test results - Reliable, flexible and punctual - Strong communication skills - Functional knowledge of spoken and written...