Bilingual Drug Safety and Medical Information

2 weeks ago


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 Scientific Affairs Department at Bayshore Specialty Rx both internally and externally as required and ensure compliance with Canadian Adverse Event reporting guidelines, Good Pharmacovigilance practices and Medical Information practices.

**A DAY IN THE LIFE**:

- Manage AE/PV inbox and conduct follow ups as required.
- Perform data entry of safety events into internal database (CRM).
- Assist with collection, processing, quality check and reporting/submission of Safety events (initial and follow-up) as per the program and department requirements.
- Conduct follow-ups for information from initial reporter and fill in gaps as necessary.
- Assist in collecting all the information required to complete RCA investigation and CAPA for quality deviations.
- Support with reconciliation activities as per the program requirements.
- Support to conduct activities related to source data verification as per the program requirements and/or PV agreement.
- Provide and support medical information services and participates in coverage after business hours, as required.
- Use available resources and FAQs to provide accurate and timely responses (verbal and/or written) to medical information queries.
- Handles, identifies and obtains pertinent data, and forwards adverse events (AEs), product quality complaints (PQCs) and medical information (MI) inquiries as per the policy and procedures.
- Support with audits as needed.
- Build excellent rapport with the internal and external customers

Job Qualification
- Degree or Diploma in a health and life sciences related field or equivalent combination of education and healthcare experience
- 1-2 years of PV experience or related Healthcare work experience (in Drug/Medical Information, Medical Affairs, Regulatory Affairs, Clinical Trials or Healthcare call center environment).
- Bilingual (English/French) is strongly preferred and will be an asset.
- Knowledge of Health Canada guidelines on Reporting Adverse Reactions for Marketed Health Products, Global PV regulations, ICH guidelines and Pharmacovigilance auditing.
- Excellent written, verbal communication and facilitation skills.
- Excellent organizational & critical thinking skills.
- Strong and proven attention to detail.
- Ability to work with strict timelines and handle multiple priorities.
- Flexible, adaptable and able to work under pressure and convey a sense of urgency.
- Demonstrated initiative and accountability and be able to work under mínimal supervision.
- Excellent customer service skills to deal with client questions, sometimes under difficult circumstances. Be able to handle challenging discussions.
- Team Player with ability to function in a multi-disciplinary environment and promote collaboration.

Bilingual in French.

Bayshore is committed to a high quality and safe environment for both our staff and clients/patients. At Bayshore all new hires must have received the full series of a COVID-19 vaccine or combination of COVID-19 vaccines approved by Health Canada (e.g., two doses of a two dose vaccine series or one dose of a single
- dose vaccine series); AND have received the final dose of the COVID-19 vaccine at least 14 days prior to the official start date of hire. Medical exemptions or any other kinds of requested exemptions based upon Human Rights Code will be considered on a case-by-case basis. Bayshore operates in accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and applicable Provincial Human Rights Code



  • Mississauga, Canada Bayshore HealthCare Full time

    The Bilingual Drug Safety and Medical Information (DSMI) Specialist is responsible for managing and overseeing 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 Department at Bayshore...


  • Mississauga, Canada Bayshore HealthCare Full time

    **ABOUT THE ROLE**: Drug Safety and Medical Information (DSMI) Specialist is responsible for managing and overseeing 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 Department at...


  • 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,...


  • Mississauga, Canada Bayshore HealthCare Full time

    **ABOUT THIS ROLE**: The Reimbursement Specialist will provide drug coverage support to physicians and patients, follow up on submissions pertaining to obtaining coverage through private and provincial drug plans, ensure patients have access to their prescribed treatments in a timely manner, act as a resource to physicians who are prescribing this medication...


  • Mississauga, Canada Bayer Full time

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...


  • Mississauga, Canada EightSix Network Inc Full time

    Bilingual Medical Customer Experience Associate Part Time / Full Time Bilingual Medical Customer Experience Associate Science & Humans is a leading hormone health platform based in Mississauga, ON. Our end-to-end digital platform offers scientifically proven treatments, products, and devices for Hormones, Aging-well, Longevity, and Sexual wellness....


  • Mississauga, Canada EightSix Network Inc Full time

    Bilingual Medical Customer Experience Associate Part Time / Full Time Bilingual Medical Customer Experience AssociateScience & Humans is a leading hormone health platform based in Mississauga, ON. Our end-to-end digital platform offers scientifically proven treatments, products, and devices for Hormones, Aging-well, Longevity, and Sexual wellness. With...


  • Mississauga, Canada EightSix Network Inc Full time

    Bilingual Medical Customer Experience Associate Part Time / Full Time Bilingual Medical Customer Experience AssociateScience & Humans is a leading hormone health platform based in Mississauga, ON. Our end-to-end digital platform offers scientifically proven treatments, products, and devices for Hormones, Aging-well, Longevity, and Sexual wellness. With...


  • Mississauga, Canada EightSix Network Inc Full time

    Bilingual Medical Customer Experience Associate Part Time / Full Time Bilingual Medical Customer Experience AssociateScience & Humans is a leading hormone health platform based in Mississauga, ON. Our end-to-end digital platform offers scientifically proven treatments, products, and devices for Hormones, Aging-well, Longevity, and Sexual wellness. With...


  • Mississauga, Canada EightSix Network Inc Full time

    Bilingual Medical Customer Experience Associate Part Time / Full Time Bilingual Medical Customer Experience AssociateScience & Humans is a leading hormone health platform based in Mississauga, ON. Our end-to-end digital platform offers scientifically proven treatments, products, and devices for Hormones, Aging-well, Longevity, and Sexual wellness. With...


  • Mississauga, ON, Canada EightSix Network Inc Full time

    Bilingual Medical Customer Experience Associate Part Time / Full Time Bilingual Medical Customer Experience Associate Science & Humans is a leading hormone health platform based in Mississauga, ON. Our end-to-end digital platform offers scientifically proven treatments, products, and devices for Hormones, Aging-well, Longevity, and Sexual wellness. With...


  • Mississauga, Canada ZOLL Medical Corporation Full time

    At ZOLL, we're passionate about improving patient outcomes and helping save lives.We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.The Resuscitation...


  • Mississauga, Canada ZOLL Medical Corporation Full time

    At ZOLL, we're passionate about improving patient outcomes and helping save lives.We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.The Resuscitation...


  • Mississauga, Canada ZOLL Medical Corporation Full time

    At ZOLL, we're passionate about improving patient outcomes and helping save lives.We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.The Resuscitation...


  • Mississauga, Canada ZOLL Medical Corporation Full time

    At ZOLL, we're passionate about improving patient outcomes and helping save lives.We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.The Resuscitation...


  • Mississauga, Canada Electrical Safety Authority Full time

    Electrical Safety Authority (ESA) has a clear mandate from the Ontario government. Everything we do aims to improve electrical safety for the public. To do this, we anticipate, understand and prevent electrical-related harms. As an HRIS Specialist , you will play a pivotal role in managing and optimizing our Human Resources Information Systems (HRIS). You...


  • Mississauga, Canada Electrical Safety Authority Full time

    Electrical Safety Authority (ESA) has a clear mandate from the Ontario government. Everything we do aims to improve electrical safety for the public. To do this, we anticipate, understand and prevent electrical-related harms. As an HRIS Specialist , you will play a pivotal role in managing and optimizing our Human Resources Information Systems (HRIS). You...


  • Mississauga, Canada Electrical Safety Authority Full time

    Electrical Safety Authority (ESA) has a clear mandate from the Ontario government. Everything we do aims to improve electrical safety for the public. To do this, we anticipate, understand and prevent electrical-related harms. As an HRIS Specialist , you will play a pivotal role in managing and optimizing our Human Resources Information Systems (HRIS). You...


  • Mississauga, Canada Bayshore HealthCare Full time

    **ABOUT THE ROLE**: This position will focus on the management of Data & Reporting, Process Design Improvements, and Program Development to enhance and expand the Specialty Drug Care Program. The Manager, Operations and Development reports directly to the National Lead, Drug Plan Solutions. **_ This position is fully_** remote**. **A DAY IN THE LIFE**: -...

  • Medical Writer

    3 weeks ago


    Mississauga, Canada Pharma Medica Research Inc. Full time

    Pharma Medica Research (PMRI) is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. We are actively looking for exceptional and passionate individuals who want to work with an exceptional team in healthcare. If you strive for learning, innovation and original thinking you will...