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.
JOB SPECIFIC 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.
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.
GENERAL DUTIES AND RESPONSIBILITIES
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.
TECHNICAL QUALIFICATIONS & EXPERIENCE
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.
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.