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Posted 8h ago

DSMI Coordinator

@ Bayshore HealthCare
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Toronto, Ontario, Canada
OnsiteContract
Responsibilities:Manage inbox, Data entry, Respond inquiries
Requirements Summary:1-2 years PV/Healthcare experience; health/life sciences degree; knowledge of HC guidelines, ICH, GVP; multilingual skills asset.
Technical Tools Mentioned:CRM, PV software, Safety database, Microsoft Excel, PowerPoint
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Job Description

JOB SUMMARY

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. The candidate will be in regular/permanent contact with colleagues and clients in various Canadian provinces, therefore, fluency in a language other than French is an asset.

DUTIES AND RESPONSIBILITIES

  • 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.
  • If needed, assist with collection, processing, quality check and reporting of Safety events (initial and follow-up) as per the program requirements.
  • If needed, correct any errors that were identified in the submitted AE reports.
  • 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.
  • 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.
  • Handle, identify and obtain pertinent data, and forward 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.
  • Maintains confidentiality of patient, client, and corporate information at all times.
  • Participates in proactive Health and Safety activities while performing all duties.
  • Is responsible to notify immediate Supervisor of any Health and Safety risks or concerns.
  • Employee will maintain relevant level of knowledge of ICH (International Conference on Harmonization), GDP (Good Documentation Practices), GCP (Good Clinical Practice), Health Canada GVP (Good Pharmacovigilance Practices), Health Canada Adverse Event Reporting guidelines, and familiarity with Canada Vigilance-MedEffect Program, as appropriate to their hired role which is to be provided at time of hire and on an as needed basis. With this knowledge the employee will perform the work as required by their assigned function and will be provided with regular updates as required.
  • Participates in processes relating to regulatory and/or contractual reporting requirements.
  • Adheres to Bayshore’s Policies and Procedures.
  • Completes other tasks as requested/required.

%3Cp class=%22MsoNormal%22 style=%22line-height:normal;margin-bottom:0in;mso-layout-grid-align:none;mso-pagination:none;text-align:justify;text-autospace:none;%22%3E%3Cspan style=%22color:black;font-family:%26quot;Calibri Light%26quot;,sans-serif;%22%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;mso-themecolor:text1;%22%3E%3Cstrong%3EQUALIFICATIONS%3Co:p%3E%3C/o:p%3E%3C/strong%3E%3C/span%3E%3C/span%3E%3C/p%3E%3Cp class=%22MsoNormal%22 style=%22line-height:normal;margin-bottom:0in;mso-layout-grid-align:none;mso-pagination:none;text-align:justify;text-autospace:none;%22%3E%3Cspan style=%22color:black;font-family:%26quot;Calibri Light%26quot;,sans-serif;%22%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;%22%3EEDUCATION%3Co:p%3E%3C/o:p%3E%3C/span%3E%3C/span%3E%3C/p%3E%3Cp class=%22MsoNormal%22 style=%22line-height:115%;margin-left:.25in;%22%3E%3Cspan style=%22color:black;font-family:%26quot;Calibri Light%26quot;,sans-serif;%22%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;%22%3EDegree or Diploma in a health and life sciences related field%26nbsp;or equivalent combination of education and healthcare experience.%3C/span%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;mso-spacerun:yes;%22%3E%26nbsp;%3C/span%3E%3Cspan 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style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;%22%3E1-2 years of PV experience or related Healthcare work experience (in Drug/Medical Information, Medical Affairs, Regulatory Affairs, Clinical Trials or Healthcare call center environment).%3C/span%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;mso-spacerun:yes;%22%3E%26nbsp;%3C/span%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;%22%3E%3Co:p%3E%3C/o:p%3E%3C/span%3E%3C/span%3E%3C/p%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22color:black;line-height:115%;margin-bottom:0in;mso-list:l1 level1 lfo1;%22%3E%3Cp style=%22text-align:justify;%22%3E%3Cspan style=%22font-family:%26quot;Calibri Light%26quot;,sans-serif;%22%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;%22%3EFluent in a language other than French is an asset%3Co:p%3E%3C/o:p%3E%3C/span%3E%3C/span%3E%3C/p%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22color:black;line-height:115%;margin-bottom:0in;mso-list:l1 level1 lfo1;%22%3E%3Cp style=%22text-align:justify;%22%3E%3Cspan style=%22font-family:%26quot;Calibri Light%26quot;,sans-serif;%22%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;%22%3EKnowledge of Health Canada guidelines on Reporting Adverse Reactions for Marketed Health Products, Global PV regulations, ICH guidelines and Pharmacovigilance auditing.%3C/span%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;mso-spacerun:yes;%22%3E%26nbsp;%3C/span%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;%22%3E%3Co:p%3E%3C/o:p%3E%3C/span%3E%3C/span%3E%3C/p%3E%3C/li%3E%3C/ul%3E%3Ch1 style=%22margin-bottom:6.0pt;%22%3E%3Cspan style=%22color:black;font-size:11.0pt;%22%3E%3Cspan style=%22line-height:107%;mso-ansi-language:EN-US;mso-bidi-font-family:%26quot;Calibri Light%26quot;;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-spacerun:yes;%22%3E%26nbsp;%3C/span%3E%3Cspan style=%22line-height:107%;mso-ansi-language:EN-US;mso-bidi-font-family:%26quot;Calibri Light%26quot;;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;%22%3EOTHER SKILLS AND ABILITIES%3Co:p%3E%3C/o:p%3E%3C/span%3E%3C/span%3E%3C/h1%3E%3Cul style=%22margin-top:0in;%22 type=%22disc%22%3E%3Cli class=%22MsoNormal%22 style=%22color:black;line-height:115%;margin-bottom:0in;mso-list:l0 level1 lfo2;%22%3E%3Cspan style=%22font-family:%26quot;Calibri Light%26quot;,sans-serif;%22%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;%22%3EExcellent written, verbal communication and facilitation skills.%3Co:p%3E%3C/o:p%3E%3C/span%3E%3C/span%3E%3C/li%3E%3C/ul%3E%3Cul style=%22margin-top:0in;%22 type=%22disc%22%3E%3Cli class=%22MsoNormal%22 style=%22color:black;line-height:115%;margin-bottom:0in;mso-list:l1 level1 lfo1;%22%3E%3Cspan style=%22font-family:%26quot;Calibri Light%26quot;,sans-serif;%22%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;%22%3EExcellent organizational %26amp; critical thinking skills.%3Co:p%3E%3C/o:p%3E%3C/span%3E%3C/span%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22color:black;line-height:115%;margin-bottom:0in;mso-list:l1 level1 lfo1;%22%3E%3Cspan style=%22font-family:%26quot;Calibri Light%26quot;,sans-serif;%22%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;%22%3EStrong and proven attention to detail.%3Co:p%3E%3C/o:p%3E%3C/span%3E%3C/span%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22color:black;line-height:115%;margin-bottom:0in;mso-list:l1 level1 lfo1;%22%3E%3Cspan style=%22font-family:%26quot;Calibri Light%26quot;,sans-serif;%22%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;%22%3EAbility to work with strict timelines and handle multiple priorities.%3Co:p%3E%3C/o:p%3E%3C/span%3E%3C/span%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22color:black;line-height:115%;margin-bottom:0in;mso-list:l1 level1 lfo1;%22%3E%3Cspan style=%22font-family:%26quot;Calibri Light%26quot;,sans-serif;%22%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;%22%3EFlexible, adaptable, and able to work under pressure and convey a sense of urgency.%3Co:p%3E%3C/o:p%3E%3C/span%3E%3C/span%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22color:black;line-height:115%;margin-bottom:0in;mso-list:l1 level1 lfo1;%22%3E%3Cspan style=%22font-family:%26quot;Calibri Light%26quot;,sans-serif;%22%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;%22%3EDemonstrated initiative and accountability and be able to work under minimal supervision.%3Co:p%3E%3C/o:p%3E%3C/span%3E%3C/span%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22color:black;line-height:115%;margin-bottom:0in;mso-list:l1 level1 lfo1;%22%3E%3Cspan style=%22font-family:%26quot;Calibri Light%26quot;,sans-serif;%22%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;%22%3EExcellent customer service skills to deal with client questions, sometimes under difficult circumstances. Be able to handle challenging discussions.%3Co:p%3E%3C/o:p%3E%3C/span%3E%3C/span%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22color:black;line-height:115%;margin-bottom:0in;mso-list:l1 level1 lfo1;%22%3E%3Cspan style=%22font-family:%26quot;Calibri Light%26quot;,sans-serif;%22%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;%22%3ETeam Player with ability to function in a multi-disciplinary environment and promote collaboration.%3Co:p%3E%3C/o:p%3E%3C/span%3E%3C/span%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22color:black;line-height:115%;margin-bottom:0in;mso-list:l1 level1 lfo1;%22%3E%3Cspan style=%22font-family:%26quot;Calibri Light%26quot;,sans-serif;%22%3E%3Cspan style=%22mso-ansi-language:EN-US;mso-ascii-theme-font:major-latin;mso-bidi-theme-font:major-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-hansi-theme-font:major-latin;%22%3EProficiency with basic computer skills, excel, PowerPoint, reporting tools etc. Prior experience with a Pharmacovigilance reporting software and/or safety databases applications an asset.%3Co:p%3E%3C/o:p%3E%3C/span%3E%3C/span%3E%3C/li%3E%3C/ul%3E