Drug Safety and Medical Information (DSMI) Specialist is responsible for managing and overseeing 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, take the lead in supporting program specific PV audits, and ensure compliance with Canadian Adverse Event reporting guidelines and Good Pharmacovigilance (PV) practices and Medical Information (MI) practices.
JOB SPECIFIC DUTIES AND RESPONSIBILITIES
Prepare Pharmacovigilance (PV) reports (Adverse Events/Product Quality Complaints) and ensure the details are accurate and valid.
Ensure timely submission of initial and follow-up PV reports to the Pharmaceutical client or to Health Canada (MHPD) as per the program requirements and/or PV agreement.
Entry of PV reports (Adverse Events/Product Quality Complaints), including late reports, follow-up reports into CRM.
Preparation and submission of reconciliation reports as per the program requirements and/or PV agreement.
Perform QC (quality check) of journal notes/PIRs/RSN calls/Lab reports/PV reports and other applicable documents to ensure compliance with PV reporting requirements.
As required, manage activities related to source data verification.
Perform QC activities including monthly quality reviews as per agreed upon sample and timelines.
As required, complete Non-conformance/Quality Management Reports (QMRs/CAPAs) to ensure compliance with program requirements.
As required, oversee management of AE/PV inbox and conduct follow-ups.
As needed, create or update program specific work instructions and process workflows as required.
Ensure compliance with program specific PV training, product training and education and PV reporting portal training, and ensure compliance with annual re-training as mandated and required by the program.
As required, deliver or assist in delivering program specific PV training, product training or reporting portal training to new program personnel (including injection/infusion nurses) and assist in annual retraining as mandated and required by the program.
As needed, lead PV meetings with Pharmaceutical client (s) as a Bayshore Specialty Rx PV representative and discuss any identified trends and process improvements.
Take the lead in supporting PV audit preparation and also support other program specific audits.
As required, act as the back-up for Team Lead/Manager, DSMI.
Build excellent rapport with the Pharmaceutical client’s Pharmacovigilance team.
Suggest and establish best PV practices.
Provide accurate and timely responses (verbal and/or written) to medical information queries.
Develops standard MI inquiry responses in consultation with Drug Safety and Medical information (MI) lead, peers and in collaboration with pharmaceutical client.
Conduct literature search and review published evidence to formulate a response for complex medical inquiries from Healthcare professionals (HCPs).
Ensure that all key performance indicators for Medical Information related tasks and deliverables are met.
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.
Participates in coverage for escalated MI inquiry management after business hours.
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.
TECHNICAL QUALIFICATIONS & EXPERIENCE
Degree in a health and life sciences related field at a minimum, professional advanced scientific degree preferred or equivalent combination of education and experience.
3-5 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 an asset.
Knowledge of Health Canada guidelines on Reporting Adverse Reactions for Marketed Health Products, Global PV regulations, ICH guidelines and Pharmacovigilance auditing.
Strong knowledge of drug benefit/risk profile, various disease states, internal medicine, physiology, toxicology and pharmacology will be considered an asset.
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.