Bilingual in French and English is RequiredThis will be a 3 Month Contract PositionReporting to the Pharmacovigilance Manager with a dotted line to the Program Manager, the Bilingual Pharmacovigilance (PV) Specialist I is responsible for supporting the collection, intake, processing, quality check and reporting of Safety events (Adverse Events and / or Product Complaints).
The incumbent will represent the Pharmacovigilance (PV) Department at Bayshore Specialty Rx both internally and externally as required, participate in program specific PV audits, and ensure compliance with Canadian Adverse Event reporting guidelines and Good Pharmacovigilance practices.
JOB SPECIFIC DUTIES AND RESPONSIBILITIESIf required, enter or assist in the entry of Safety / PV reports (Adverse Events / Product Complaints), including late reports, follow-up reports into CRM and submit to the Pharmaceutical client or to Health Canada (MHPD) as per the program requirements and / or PV agreement.
As required, review PV reports received from program personnel for accuracy and validity.Ensure timely submission of initial and follow-up PV reports as per the program requirements and / or PV agreement.
As needed, assist / conduct activities related to source data verification as per the program requirements and / or PV agreement.
As needed, assist / conduct reconciliation activities as per the program requirements and / or PV agreement.As required, assist in the compilation of Quality Management Reports (QMRs / CAPAs) to ensure compliance with program requirements.
As needed, collaborate in the creation and revision of program specific work instructions and process workflows as required.
As needed, provide PV reporting updates as received from Pharmaceutical client (s).As required, manage AE / PV inbox and conduct follow-ups.
As needed, support meetings with Pharmaceutical client (s) as a Bayshore Specialty Rx PV representative.Build excellent rapport with the internal Pharmacovigilance and nursing team.
GENERAL DUTIES AND RESPONSIBILITIESMaintains 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 & EXPERIENCEDegree in a health and life sciences related field or professional scientific degree or equivalent combination of education and experience.
1-2 years of PV experience or related Healthcare work experience (in Drug Information, Medical Affairs, Regulatory Affairs, Clinical Trials or Healthcare call center).
Bilingual (English / French) is required.Knowledge of Health Canada guidelines on Reporting Adverse Reactions for Marketed Health Products, Global PV regulations, ICH guidelines and Pharmacovigilance auditing.
Strong knowledge of various disease states, internal medicine, physiology, toxicology and pharmacology will be considered an asset.
GENERAL REQUIREMENTSExcellent 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.