Contract Senior Pharmacovigilance Scientist

5 days ago

Montreal, Canada Brunel Full time

The Senior Scientist is assigned to projects based on scientific competency and training. The Scientist will ensure the overall integrity/quality of assigned studies. The Senior Scientist can also be designated as the main contact for client interactions laboratory for their assigned projects and have Direct Reports.

Responsibilities

  • Will be assigned to assay development, qualification, validation and production, expert in multiple assay types and mentor for more junior staff. Could have associate scientists and/or scientist I and II reporting to them.
  • Autonomous and proficient in developing, planning, managing, conducting, reporting and troubleshooting multiple assay types to ensure scientific quality, regulatory expectations, and client satisfaction.
  • Assigned to studies and tasks based on scientific competency and training (can include method development, validation or sample analysis projects).
  • For validations and sample analysis, the Scientist can be assigned as Bioanalytical Principal Investigator and is the first point of contact for PM and/or clients for laboratory services and will manage and conduct method development, qualification, validation and production studies for clinical and non-clinical studies in compliance with the protocol/study plan, amendments, GCP, GLPs, SOPs and Best Practices.
  • Manage project and order appropriate material, as needed.
  • Provide QC support on studies assigned to other team members in laboratory based on training and competencies.
  • Perform data batch review, perform multi-batch trend analysis, complete documentation as required by tracking deviations, events and reports of non-compliance and review or approved Memo to File or SOP/Protocol/Study Plan deviations.
  • Provide a report and/or reporting of results, within study timelines and ensure any deviations/exception events are reflected as appropriate and assure that all analysis conducted is reported and is accurate.
  • Manage timelines and scheduling commitments.
  • Review and provide comments and recommendations, as needed, for the bioanalytical portions of preclinical and clinical protocols, study plans, laboratory manuals, Data Transfer Agreements, and/or other documents, as needed.
  • Support and mentor Analysts in the daily operations for completion of sample analysis and/or validation studies and the analysts' work. Support and mentor other team members based on expertise.
  • Responsible for troubleshooting issues within the studies and be able to resolve them independently via development of appropriate procedure.
  • Organize and communicate complex data sets in a clear and concise manner to key stakeholders from diverse backgrounds.
  • To write, review and update method SOP as needed.
  • Participate in meetings with clients, conferences and scientific outreach.
  • Conduct applicable work in compliance with applicable SOPs, GCPs, GLPs, and observe all company guidelines and policies.
  • Respecting Health and Safety standards in terms of personal protection, laboratory maintenance, and work procedures.

Requirements

  • University or College degree in Chemistry, Biochemistry, Immunology or applicable field.
  • At least 3-5 years of relevant experience in regulated clinical and/or preclinical studies, preferably in a CRO environment and with Flow Cytometry.
  • Knowledge of regulatory agency guidelines, must have a deep understanding of general SOPs and have an excellent knowledge of GCP/GLP regulations.
  • Exceptional organizational skills, highly flexible, sense of urgency, excellent troubleshooting skills, client-oriented, and attentive to details.
  • Must be able to easily read and understand study plans and protocols, have the ability to coach/mentor people.
  • Good communication skills, both written and verbal in French & English (preferred).
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