Scientific Affairs Administrator (Remote) - Jobs in Ontario

Job Description

ABOUT THE ROLEThe Drug Safety Mail-Box Handling and Triage Admin; Scientific Affairs Admin is responsible for primarily triaging the Adverse Event and Pharmacovigilance Mailbox, including but not limited to collection, identification, triage, distribution of adverse events, product quality complaints and other safety information, handling queries, in addition to providing administrative support to the Scientific Affairs Drug Safety and Quality team. 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.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.A DAY IN THE LIFE

• Review designated pharmacy mailbox and applications for AEs, identify, triage AE/PQC reports, and channel the reports to the respective centralized and custom PV programs.
• Conduct follow-ups on AE reports as required.
• Assist with mailbox handling and triage for the centralized PV reporting as needed.
• Set regarding emails received in pharmacy team inbox to CRM (if required).
• Assess Date of Awareness of all incoming AE and PQC reports and triage for timely reporting as per contractual obligations.
• Assign a due date for all incoming AE and PQC reports and track completion of all due reports.
• Retrieve source emails and source documents from all applicable internal applications.
• If needed, conduct investigation for quality issues and collect all the information to complete CAPA.
• Conduct follow-ups for information from initial reporter and fill in gaps as necessary.
• If required, support with reconciliation activities as per the program requirements.
• If required, support/conduct activities related to source data verification as per the program requirements and/or PV agreement.
• Support with audits as needed.
• Support Quality team with the following but not limited to: Document Change Advisory Board meetings, Administrative support with the Quality Management System, Ethics & Compliance tasks or any additional admin tasks as needed.
• Build excellent rapport with the internal and external customers

Job QualificationWHAT YOU BRING TO THE TEAM

• Degree or Diploma in a health and life sciences related field or equivalent combination of education and healthcare experience.
• Preferably 1-2 years of administrative experience in Pharmacovigilance or related Healthcare work experience (in Drug/Medical Information, Medical Affairs, Regulatory Affairs, Clinical Trials or any 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.

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