DSMI Clinical Specialist at Bayshore Healthcare Ltd.

Mississauga, Ontario, Canada -

Full Time

Start Date

Immediate

Expiry Date

05 Jun, 26

Salary

0.0

Posted On

07 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Adverse Event Reporting, Pharmacovigilance, Medical Assessment, Stakeholder Communication, Regulatory Compliance, Good Pharmacovigilance Practices, Safety Database Documentation, Auditing, Customer Service, Continuous Improvement, Signal Detection, ICH Guidelines, GCP, GVP, French Language Fluency, English Language Fluency

Industry

Hospitals and Health Care

Description

JOB SUMMARY The DSMI Clinical Specialist is responsible for addressing client follow-up queries, conducting follow-ups with multiple stakeholders - including reporters, patients, physicians, and pharmacies, providing medical assessments, and ensuring accurate reporting of Adverse Events (AEs) and Follow-Up (FU) AEs. This role ensures compliance with Canadian Adverse Event reporting guidelines, Good Pharmacovigilance Practices (GVP), and program-specific agreements. The incumbent will represent the Pharmacovigilance Department at Bayshore Specialty Rx both internally and externally. The ideal candidate will have a healthcare professional background and strong communication skills to engage effectively with Health Care Providers across Canada.The candidate will be in regular/permanent contact with colleagues and clients in various Canadian provinces, therefore, fluency in both English and French is required. DUTIES AND RESPONSIBILITIES Drug Safety & Medical Information • Address client follow-up queries promptly and professionally. • Identify missing or additional information in accordance with applicable regulatory requirements or internal SOPs, and conduct systematic follow ups with reporters, patients, physicians, pharmacies, and other stakeholders via phone, fax, or email within agreed service level timelines. • Collaborate closely with internal teams to support timely submission of safety information and continuity of care. • Perform medical assessments of reported AEs and FU AEs, including seriousness, expectedness, causality, and product-event relationship, ensuring clinical accuracy and completeness. • Ensure timely submission of initial and follow-up PV reports to the pharmaceutical client orto Health Canada (MHPD) as per the program requirements and/or PV agreement. • Document all follow-up interactions and assessments in the safety database, maintaining audit-ready records. • Support reconciliation activities and source data verification as per PV agreements. • Participate in audits and inspections by providing accurate follow-up documentation. • Maintain a high level of customer service while building positive working relationship with HCP offices • Identify trends, recurring data gaps, or process issues and contribute to continuous improvement initiatives within follow-up activities. • Contribute to the development, review and continuous improvement of Pharmacovigilance SOPs to ensure ongoing regulatory compliance and operational effectiveness. • Support signal detection activities through trend analysis, case clustering review and contribution to safety evaluations. General Duties and Responsibilities • Maintain confidentiality of patient, client, and corporate information always. • Participate 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, andfamiliarity 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. • Participate in processes relating to regulatory and/or contractual reporting requirements. • Adhere to Bayshore’s Policies and Procedures. • Complete other tasks as requested. QUALIFICATIONS EDUCATION • Degree/Diploma in Nursing, Pharmacy, or another healthcare-related field (mandatory). • Degree in a health or life sciences related field, professional advanced scientific degree preferred or equivalent combination of education and experience. 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). • Must be fluent in verbal and written communication and interpersonal skills for both English and French. (Applicable for provinces/regions with French language service requirements) • Prior experience in patient/HCP communication and case follow-up preferred. • 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. • Knowledge of MedDRA terminology and coding conventions is considered an asset. OTHER SKILLS AND ABILITIES • Excellent verbal and written communication skills. • Strong attention to detail and ability to work under strict timelines and handle multiple priorities. • Proficiency in PV databases and MS Office tools. • Ability to handle challenging conversations professionally. • Team player with ability to function in a multi-disciplinary environment.

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Responsibilities

The DSMI Clinical Specialist handles client follow-up queries, coordinates with reporters, patients, physicians, and pharmacies, and ensures accurate reporting of Adverse Events (AEs) and Follow-Up (FU) AEs in compliance with Canadian guidelines and GVP. This role involves performing medical assessments of reported events and representing the Pharmacovigilance Department internally and externally.