Drug Safety Associate

4 weeks ago


Canada, CA SetupmyHR Full time

Title: Drug Safety Associate


Role: Submission Specialist


Education and Experience: Any life Sciences graduate with 3-4 years experience in Submissions case processing.

Key Competencies: Level-3 proficiency in English, Working knowledge of French preferable, Located in Canada preferably with PR/work permit.


Location: Canada(Remote)

Our Client: A leading Pharma CRO/Lifesciences organization


NOTE: Only shortlisted candidates with legal authorization to work in Canada and the educational qualification mentioned will be contacted.


Brief Description of Duties:

• Play an integral role in the management of daily operational activities of the Global Submissions Team within Case processing.

• Responsible for managing the timely submission of Global ICSRs to various Health Authorities, License Partners, and CROs.

• Monitoring of Global submissions mailbox to address all the high-priority emails/ queries received from health authorities/ license partners related to ICSR submissions.

• Prepare local paper submissions to the US FDA in accordance with the Client’s processes

• Responsible for addressing daily worklist to complete submissions to all applicable reporting destinations

• Generate, Review, and Transmit reports to all Global Health Authorities including but not limited to FDA European Agencies, Health Canada, and various other Health Authorities.

• Timely submission of appropriate reports to global partners based on defined timelines as per the PVA.

• Responsible for timely submission of expedited ICSR reports to Ethics Committees and Investigators based on the country's requirements.

• Monitoring the safety database for failed transmissions to resolve the issue on time.

• Involved in preparing safety ICSR submission package to Health Authorities as per the requirements.

• Follow up with the Case Processing team and Medical Reviewers to request appropriate case correction for timely submissions of reports.

• Provide training and support to newer members of the submission team

• Collaborate with the Regulatory Intelligence team, and Safety Data Management to maintain accurate reporting rules in the Safety Database.

• Responsible for configuring clinical studies in the database, reviewing clinical trial protocols, and configuring reporting rules as per regulations.

• As a Submissions SME, support local safety managers daily for all ICSR submission-related matters.

• Identifying root causes for late ICSR submissions and providing appropriate corrective and preventive actions to the Compliance and Business Management team.

• Responsible for timely investigation, analysis, and action on health authority queries.

• Monitor and address weekly ICSR submission reconciliations with local safety managers.

• Assist the Global Pharmacovigilance team with various projects to enhance system performance.


  • Inventory Associate

    3 weeks ago


    Canada, CA Banner Health Associate Full time

    We are seeking for an organized and detail-oriented individual to join our team as an Inventory Associate. As an Inventory Associate, you will be responsible for maintaining accurate inventory records, conducting cycle counts, and assisting with inventory management. This is a great opportunity for someone who thrives in a fast-paced environment and has...

  • Plant Operator

    4 weeks ago


    Canada, CA Airswift Full time

    Job Description:Airswift is seeking a Contract Plant Operator to work with one of our major clients in the Oil & Gas industry in Lloydminster, AB. This is a 1-year contract with the possibility of extension.Upstream Thermal Operations currently has opportunities for Contract Plant Operators at our Edam and Vawn Thermal facilities. The successful candidates...

  • Global Study Director

    1 month ago


    Canada, CA ICON Strategic Solutions Full time

    Perform study management tasks as per agreed delegation/oversight by SrGSL/GSLIn partnership with internal experts and external service providers, provide oversight (as delegated by the SrGSL/GSL) to ensure study delivery of both internally-run and outsourced studies..Lead/contribute to the preparation of delegated study documents (e.g. Informed Consent...


  • Canada, CA Outright Consulting Full time

    We are currently seeking a motivated Junior Electrical Engineering Technologist, Journeyman PSE, or Electrical Engineer to join our clients field services team on a full time basis. If you are an excellent communicator and skilled problem-solver with strong attention to detail we would love to hear from you.Responsibilities:Testing and commissioning of power...

  • Industrial Hygienist

    4 weeks ago


    Canada, CA CAD Railway Industries Ltd. Full time

    Cad Rail Industries Ltd was founded in 1968 headquartered in Montreal. We take pride on being North America’s leader of full-service solutions in the freight, passenger and commuter rail industries in Canada, the United States and offshore. Cad Rail has other facilities in Calgary, Lethbridge (under Caltrax banner) and has recently been selected by the...

  • Planning Specialist

    1 month ago


    Canada, CA Morson Talent Full time

    Location: 100% Remote Duration: 1 Year (Can be extended annually) Hourly Rate: $75 - 95/hour Responsibilities: Leading or assisting in preparation of detailed work plans Leading and monitoring compliance Review scheduled work, review work that was completed and what was not and why to prepare regular reportsReview operational logs, maintaining awareness of...


  • Canada, CA RDJ Bakeries Ltd.. Full time

    RDJ Bakeries Ltd.RDJ Bakeries, a distinguished food manufacturer renowned for its exceptional crackers, is seeking talented individuals to join our growing Human Resources team. With a focus on quality and innovation, we collaborate with global partners to deliver delightful, delectable treats that captivate our customers. As a part of our diverse and...


  • Canada, CA RDJ Bakeries Ltd.. Full time

    RDJ Bakeries Ltd.RDJ Bakeries, a distinguished food manufacturer renowned for its exceptional crackers, is seeking talented individuals to join our growing Human Resources team. With a focus on quality and innovation, we collaborate with global partners to deliver delightful, delectable treats that captivate our customers. As a part of our diverse and...


  • Canada, CA PSG leadership Inc. Full time

    Our client operates a portfolio of businesses that participate in and serve Canada’s energy and infrastructure marketplace. Their strong performance and continued success are a direct reflection of the ambitious, committed, and talented professionals they hire across Canada who make a positive impact to their clients and communities.They have retained our...


  • Canada, CA ML6 Search + Talent Advisory Full time

    The Opportunity:Our client is a leading provider of high-tech products and services for some of the world’s most important industrial and research communities. In advancing this mission, we are supporting them in the hiring of an Customer Support Engineer - Plasma, who is experienced with troubleshooting and repair of Ion Beam tools including, vacuum...


  • Canada, CA ML6 Search + Talent Advisory Full time

    The Opportunity:Our client is a leading provider of high-tech products and services for some of the world’s most important industrial and research communities. In advancing this mission, we are supporting them in the hiring of an Customer Support Engineer - Plasma, who is experienced with troubleshooting and repair of Ion Beam tools including, vacuum...

  • Engineering Manager

    1 month ago


    Canada, CA Cain & Associates Full time

    Civil/Structural ManagerLocation: Canada (preference for British Columbia or Alberta)Position Overview:We are seeking a highly skilled and experienced Civil/Structural Manager to join our dynamic team. The ideal candidate will have a Professional Engineer (P. Eng) designation in either British Columbia, Alberta, or the USA, along with a proven track record...

  • Operator

    1 month ago


    Canada, CA Airswift Full time

    Job Description: Airswift is seeking a Contract Operator to work with one of our major clients in the Oil & Gas industry in Lloydminster, AB. This is a 1-year contract with the possibility of extension. We're looking for an experienced Contract Operator to join the company's Western Canada Operations at the Sand Cavern Facility near Lloydminster,...


  • Canada, CA Musashi AI North America Full time

    Musashi AI North America, Inc. is a growing hardware and software focused company that builds and develops smart vision solutions for quality assurance in manufacturing environments. Based in Waterloo, Ontario, Musashi AI North America employs a talented and dynamic team of R&D and Applications Engineers who provide unique engineering development activities...

  • Senior Counsel, Legal

    1 month ago


    Canada, CA Green Infrastructure Partners Full time

    Reporting to the Associate General Counsel, the Senior Counsel will support our operational teams with a broad range of responsibilities to help support and grow the business.Key Responsibilities:Drafting, reviewing, and negotiating a range of industry-specific and general commercial contracts between project participantsWorking closely with other internal...


  • Canada, CA Layfield Geosynthetics Full time

    Are you searching for a new opportunity to work in an energetic and motivated environment surrounded by passionate and inspired team members? Why not join the unique and rapidly growing industry of Geosynthetics?Over the past 46 years, Layfield has created innovative and sustainable geosynthetic solutions to protect our communities and environment. Since...


  • Canada, CA AtkinsRéalis Full time

    Are you looking for a company that works on major engineering projects all over the world? Do you want to make a difference by improving the daily lives of communities worldwide? Are you seeking to join an inclusive and diverse team that you can truly count on? You’ve come to the right place!Come join us in reshaping the future with AtkinsRéalis....


  • Canada, CA Celestica Full time

    SummaryWe are currently seeking a Director, Strategic Supply Chain Management to join our team to be a global supply chain focal point and primary interface with Celestica's global supply chain organization, processes and procedures. This person will have responsibilities for Inventory, Supply Chain continuity and productivity for a defined segment. The...


  • Canada, CA Celestica Full time

    SummaryWe are currently seeking a Director, Strategic Supply Chain Management to join our team to be a global supply chain focal point and primary interface with Celestica's global supply chain organization, processes and procedures. This person will have responsibilities for Inventory, Supply Chain continuity and productivity for a defined segment. The...

  • Drug Safety Associate

    4 weeks ago


    Canada SetupmyHR Full time

    Title: Drug Safety AssociateRole: Submission SpecialistEducation and Experience: Any life Sciences graduate with 3-4 years experience in Submissions case processing.Key Competencies: Level-3 proficiency in English, Working knowledge of French preferable, Located in Canada preferably with PR/work permit.Location: Canada(Remote)Our Client: A leading Pharma...

  • Drug Safety Associate

    4 weeks ago


    Canada SetupmyHR Full time

    Title: Drug Safety Associate Role: Submission Specialist Education and Experience : Any life Sciences graduate with 3-4 years experience in Submissions case processing. Key Competencies: Level-3 proficiency in English, Working knowledge of French preferable, Located in Canada preferably with PR/work permit. Location: Canada(Remote) Our Client: A...

  • Drug Safety Associate

    4 weeks ago


    Canada SetupmyHR Full time

    Title: Drug Safety AssociateRole: Submission SpecialistEducation and Experience: Any life Sciences graduate with 3-4 years experience in Submissions case processing.Key Competencies: Level-3 proficiency in English, Working knowledge of French preferable, Located in Canada preferably with PR/work permit.Location: Canada(Remote)Our Client: A leading Pharma...


  • Canada Levitt-Safety Limited Full time

    Fire Extinguisher Technician (Fly in, Fly out Fort McMurray) Levitt-Safety has an exciting opportunity for an experienced technician to join our team as a Fire Extinguisher Technician in Fort McMurray . This role offers a higher desirable compressed work schedule of 14 days on and 14 days off, 12 hour shifts with company-paid housing for...

  • Inventory Associate

    3 weeks ago


    Canada Banner Health Associate Full time

    We are seeking for an organized and detail-oriented individual to join our team as an Inventory Associate. As an Inventory Associate, you will be responsible for maintaining accurate inventory records, conducting cycle counts, and assisting with inventory management. This is a great opportunity for someone who thrives in a fast-paced environment and has...

  • Inventory Associate

    3 weeks ago


    Canada Banner Health Associate Full time

    We are seeking for an organized and detail-oriented individual to join our team as an Inventory Associate. As an Inventory Associate, you will be responsible for maintaining accurate inventory records, conducting cycle counts, and assisting with inventory management. This is a great opportunity for someone who thrives in a fast-paced environment and has...

  • Inventory Associate

    2 weeks ago


    Canada Banner Health Associate Full time

    We are seeking for an organized and detail-oriented individual to join our team as an Inventory Associate. As an Inventory Associate, you will be responsible for maintaining accurate inventory records, conducting cycle counts, and assisting with inventory management. This is a great opportunity for someone who thrives in a fast-paced environment and has...

  • Inventory Associate

    3 weeks ago


    canada Banner Health Associate Full time

    We are seeking for an organized and detail-oriented individual to join our team as an Inventory Associate. As an Inventory Associate, you will be responsible for maintaining accurate inventory records, conducting cycle counts, and assisting with inventory management. This is a great opportunity for someone who thrives in a fast-paced environment and has...

  • Inventory Associate

    3 weeks ago


    Canada Banner Health Associate Full time

    We are seeking for an organized and detail-oriented individual to join our team as an Inventory Associate. As an Inventory Associate, you will be responsible for maintaining accurate inventory records, conducting cycle counts, and assisting with inventory management. This is a great opportunity for someone who thrives in a fast-paced environment and has...

  • Inventory Associate

    3 weeks ago


    Canada Banner Health Associate Full time

    We are seeking for an organized and detail-oriented individual to join our team as an Inventory Associate. As an Inventory Associate, you will be responsible for maintaining accurate inventory records, conducting cycle counts, and assisting with inventory management. This is a great opportunity for someone who thrives in a fast-paced environment and has...

  • Inventory Associate

    3 weeks ago


    Canada Banner Health Associate Full time

    We are seeking for an organized and detail-oriented individual to join our team as an Inventory Associate. As an Inventory Associate, you will be responsible for maintaining accurate inventory records, conducting cycle counts, and assisting with inventory management. This is a great opportunity for someone who thrives in a fast-paced environment and has...


  • Canada Teck Resources Limited Full time

    Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Health and Safety Clerk (Temporary) Location: Elkford, British Columbia, CA Closing Date: May 29, 2024 Reporting to the Supervisor, Health and Safety, the Health and Safety Clerk (Temporary) is responsible for supporting Fording River’s health and safety team....

  • Caissier(ère)

    3 weeks ago


    Canada Shoppers Drug Mart Pharmaprix Full time

    **Location**: 1120 Rue Ste-Catherine Ouest, Arr. Ville-Marie, Montreal, Quebec, H3B 1H4 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...


  • Canada Shoppers Drug Mart Pharmaprix Full time

    **Location**: 810 Boul Thibeau Nord, Trois-Rivieres, Quebec, G8T 7A6 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...


  • Canada Shoppers Drug Mart Pharmaprix Full time

    **Location**: 1000 Wellington Street, Montreal, Quebec, H3C 1V4 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...


  • Canada Shoppers Drug Mart Pharmaprix Full time

    **Location**: 2740 Notre Dame Ouest, Montreal, Quebec, H3J 1P1 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...


  • Canada Levitt-Safety Limited Full time

    Red Seal Fire Sprinkler Technicians (Fly in-Fly out) Levitt-Safety in Fort McMurray, AB , has several upcoming opportunities for experienced Fire Sprinkler Technicians to join our team. If you are confident and experienced in maintenance & repairs of fire sprinkler system inspections, can read blueprints and schematics, we’d love to hear from you! ...


  • Canada Shoppers Drug Mart Pharmaprix Full time

    **Location**: 3950 Boul. Des Forges, Trois-Rivieres, Quebec, G8Y 1V7 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**: **DUTIES & RESPONSIBILITIES**: **Sales Expectations** - Promotes sales...


  • Canada Everguard Fire and Safety Everguard Incendie et Sécurité Full time

    Work Term: Permanent - Work Language: English or French - Hours: 40 to 60 hours per week - Education: Other trades certificate or diploma - Experience: 1 year to less than 2 years - Fire protection, other - Mechanics and repairers, general - or equivalent experience **Work site environment**: - At heights - Confined spaces - Wet/damp - Noisy **Work...


  • Canada Walmart Canada Corp Full time

    The regulated pharmacy technician as a health care professional supports the role of the pharmacist through the safe and efficient management of all aspects of drug distribution that do not require the pharmacists clinical knowledge, skills and judgment. Assess prescription for clarity, completeness, authenticity and legal requirements. Determine and...