Pharmacovigilance Associate I

• Accountable for recognizing Adverse Event (AE) / Adverse Drug Reactions (ADR) / Adverse Drug Experience (ADE), Medical Device Incident (MDI) information from the source document
• Accountable for Individual Case Safety Report (ICSR) processing as per applicable Standard Operating Procedures (SOPs) and Work Instructions (WI) including but not limited to Triage, Duplicate Search, Data Entry, MedDRA coding, Narrative Writing, Medical Evaluation, Seriousness assessment, expectedness assessment, Causality assessment, Reportability Assessment, Expedite, and Periodic submission, etc.
• Accountable to perform AE / ADR/ ADE / MDI reports’ reconciliation with internal and external stakeholders
• Accountable to perform Literature Review as per the applicable organization’s SOP and WI
• Accountable for recognizing, processing, and reporting Product Quality Complaints (PQC) information as per applicable SOP and WI
• Accountable for managing Mailboxes including filing emails in appropriate folders
• Accountable to review and file incoming Faxes in the appropriate folder
• Accountable to act as a contact point for the client
• Work directly with internal and external stakeholders to request additional information or clarification as necessary
• Assist in audit preparation
• File and store all documents as per applicable SOP and WI
• Other tasks assigned by the Manager, as needed
• May be required to be on standby / on-call as part of this role

• Bachelor’s degree in a life sciences program
• 1-2 years of experience in Pharmacovigilance, Medical Information, Clinical Research, and/or equivalent and related experience in the pharmaceutical industry
• Strong knowledge of the pharmacovigilance industry including up-to-date knowledge of Health Canada, US-FDA, and ICH’s Pharmacovigilance requirements and guidelines
• Familiarity with MS Word, MS Excel, MS PowerPoint, other MS Office Programs, and Adobe Pro
• Familiarity with Good Documentation Practice (GDP) and Quality Management Systems (QMS) is an asset
• Strong business and financial acumen
• Strong analytical and mathematical skills
• Ability to communicate effectively both orally and in writing
• Effective interpersonal and leadership skills
• Effective organizational skills, attention to details
• Ability to consistently meet deadlines
• Excellent problem-solving skills
• ability to resolve issues effectively and efficiently
• Excellent presentation skills
• Able to work any 8-hour shift between 8:00 AM-8 PM, if necessary
• Can-do attitude, with proven ability to meet strict deadlines

Familiarity with Good Documentation Practice (GDP) and Quality Management Systems (QMS)

• medical
• dental
• vision care
• comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
• support for working families
• backup dependent care
• adoption assistance
• infertility coverage
• family building support
• behavioral health solutions
• paid parental leave
• paid caregiver leave
• variety of training programs
• professional development resources
• opportunities to participate in mentorship programs
• employee resource groups
• volunteer activities