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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Pharmacovigilance and clinical research, with strong analytical skills and attention to detail. Proficient in data management and communication, ensuring compliance with regulatory guidelines and effective client interactions.
Highest-signal resume keywords
Pharmacovigilance KnowledgeClinical Research ExperienceBilingual English/FrenchAttention To DetailAnalytical Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data EntrySource Data VerificationAdverse Event ReportingMedical TerminologyQuality ChecksTranscriptionTranslationRedactionReconciliation ReportsDocument Management
Soft Skills
Effective CommunicationInterpersonal SkillsOrganizational SkillsProblem-Solving SkillsAdaptability
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointOffice ProgramsProgram-Specific Databases
Industry Keywords
Clinical InformationDrug SafetyHealth Canada GuidelinesUS FDA GuidelinesEMEA GuidelinesICH GuidelinesNon-ConformanceCAPA ProcessMedical Literature ScreeningPharmaceutical Fields
About the role
Key responsibilities & impact- Receive, scan and document pertinent clinical information in compliance with SOP/protocol and applicable legislation
- Work with internal and external clients to request additional information or clarification
- Review source data documents, including visit report/PIR review
- Triage adverse event information and product quality complaints according to client needs
- Enter and submit adverse event information and product quality complaints into program-specific databases
- Sort and file incoming documents
- Perform quality checks on adverse event reports as directed by work instructions
- Assist with and/or perform source data verification checks
- Screen medical and scientific literature for safety information
- Prepare reconciliation reports on weekly, monthly and other schedules
- Perform transcription, translation and redaction activities
- Prepare and conduct solicited follow-up letters and data clarifications
- Assist and participate in the non-conformance/CAPA process
- Perform other duties and tasks as required
Requirements
What you’ll need- Minimum college level education required
- A diploma or degree with a concentration in Life Sciences is a strong asset
- 1-3 years experience in Medical Information, Clinical Research or Drug Safety or equivalent and related experience in pharmacy or pharmaceutical fields
- Knowledge of the Pharmacovigilance industry
- Up-to-date knowledge of pharmacovigilance guidelines of Health Canada, US FDA, EMEA and ICH
- Adaptability to change and ability to learn new skills as required
- Experience in the medical and/or pharmaceutical fields; medical terminology is an asset
- Bilingual English/French is an asset
- Strong analytical skills
- Ability to communicate effectively both orally and in writing
- Effective interpersonal skills
- Effective organizational skills and ability to multitask
- Superior, proven attention to detail
- Ability to consistently meet deadlines
- Excellent problem-solving skills and ability to communicate and/or resolve issues effectively and efficiently
- Computer skills, including Microsoft Word, Excel, PowerPoint and other Office Programs
- Good internet required for remote work
Benefits
Comp & perks- Medical, dental, and vision care
- Backup dependent care
- Adoption assistance
- Infertility coverage
- Family building support
- Behavioral health solutions
- Paid parental leave
- Paid caregiver leave
- Training programs
- Professional development resources
- Mentorship programs
- Employee resource groups
- Volunteer activities
- Remote work arrangement
- Good internet required for remote work
