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Drug Safety Specialist II

Amyantek Inc.

This is a Full-time position in Toronto, ON posted July 27, 2017.

Detailed Job Description: Bilingual Drug Safety Associate Responsible for all stages of domestic and foreign adverse event reporting for assigned clinical study and post-marketing drugs. Collects data regarding adverse events, particularly short-and long-term effects. Reviews and determines regulatory reporting requirements based on assessment of seriousness, causality and expectedness/listedness in accordance with regulatory guidelines and product labeling. Prepares adverse events reports for submission to Health Canada within the appropriate reporting timeframes. Verifies accuracy, completeness and validity of report information. Applies medical judgment when interacting with healthcare professionals and consumers to obtain and follow up on reports of possible adverse events. At this level, the position is expected to participate in activities aligned with the departmental and corporate business objectives. At the departmental level, may provide expertise on product-specific case assessment and processes to colleagues. Participates in inspection/audit readiness activities such as the Health Canada Post-Market Reporting Compliance Inspection. Assists in the review and implementation of training and cases processing procedural documents. Collaborates with Global Medical Safety (GMS), Global Clinical Operations (GCO), and internal/external business partners to address product safety concerns (e.g., Health Canada inquiries, product recalls and risk communication). Provides input to cross-functional teams to address protocol/program design and safety reporting requirement. Provides safety reporting training to third-party vendors (market research, patient assistance providers) with manager¿s oversight. May be assigned to special projects aligned with the area of responsibility and the developmental goals. Major Responsibilities: Describe key responsibility areas and approximate time spent on each. 70-90% of the time: 1. Evaluates adverse event reports, assesses regulatory status (seriousness and expectedness/relatedness) in order to prioritize workload. 2. Prioritizes workload for assigned products and liaises with other Safety and Compliance Associates to ensure timely processing. 3. Processes adverse event reports from spontaneous sources, clinical trials, studies and marketing activities (including healthcare professionals and consumers) in accordance with company standard operating procedures (SOP) and guidelines for maintaining regulatory compliance. 4. Performs risk and quality assessments on adverse event reports. 5. Requests product complaint investigation on appropriate cases according to the SOP. 6. Determines the need for and requests follow-up using appropriate communication methods (e.g. fax, email, telephone or site visit) in addition to complying with the SOPs. 7. Participates and may lead team discussion for both case processing and scientific product knowledge. 8. Provides coverage to other therapeutic teams as needed. 9. Liaises with GCO/medical affairs and other business partners to provide safety input. 10. Responds to requests initiated by legal council and the Safety Management Team (SMT). 11. Collaborates with GMS and international affiliates as required for operational, compliance and/or safety functions. 10-30% of the time 1. Provides adverse event report training to employees and vendors as required. 2. Mentors and trains safety associates, compliance coordinators, and department administrator. 3. Participates in special projects as assigned. Job Knowledge Requirements: Relevant knowledge and experience University degree in Pharmacy or Nursing; Medical degree or the equivalent Healthcare professional background including but not limited to, pharmacist, nurse, medical doctor, dentist and nutritionist Experience should include at least 1 year in clinical practice or pharmaceutical industryWorking knowledge of drug safety/ experience in AE reporting Knowledge and experience with safety processing preferred.

Skills Required

  • Education level: None
  • Work experience (years): None


Salary: N/D