Pharmacovigilance Analyst

Cencora•CAN > ON > Remote, ON

2d•CA$55,002 - CA$109,901•Onsite

About The Position

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Requirements

Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience required.
2+ years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a related field required.

Nice To Haves

Certification in regulatory affairs, quality management, compliance, auditing preferred.

Responsibilities

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 codding, Narrative Writing, Medical Evaluation, Seriousness assessment, expectedness assessment, Causality assessment, Reportability Assessment, Expedite, and Periodic submission, etc.
Accountable to perform Literature Review as per the applicable organization’s SOP and WI
Accountable preparation and/or review of aggregate reports as per applicable SOP and WI including but not limited to Annual Summary Reports (ASR), Issue Related Summary Report (IRSR), Periodic Safety Update Reports (PSURs), Periodic Benefit- Risk Evaluation Report (PBRERs), Periodic Adverse Drug Experience Report (PADER), Developmental Safety Update Report (DSUR), etc.
Accountable for performing Signal Detection as per applicable SOP and WI
Accountable for preparation and/or update of Risk Management Plan (RMP) or Risk Evaluation and Mitigation Strategies (REMS) and associated documents
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.

Benefits

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