Drug Safety and Medical Information Specialist

Bayshore HealthCare

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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 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.

PLEASE NOTE: This role is work from home.

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).
  • Retrieve source emails and source documents from the internal database.
  • 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).
  • 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 minimal 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.
  • Proficiency with basic computer skills, excel, PowerPoint, reporting tools etc. Prior experience with a Pharmacovigilance reporting software and/or safety databases applications an asset.

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

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