Pharmacovigilance Analyst

🕒 August 10

🇨🇦 Canada – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧐 Analyst

👻 Ghost score 49%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Cencora

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

Cencora is a company dedicated to improving the health and well-being of both people and animals globally. Built on the legacy of AmerisourceBergen, Cencora offers a wide range of industry-leading solutions that encompass specialty logistics, warehousing, drug research, clinical development support, and more. They provide commercialization and patient access support and offer wholesale and specialty distribution services. Cencora serves a diverse clientele, including pharmaceutical companies, physician practices, pharmacies, and health systems. The company also extends its services to animal health, managing operations and delivering products for animal pharmaceutical care. With a strong global footprint, Cencora aims to reshape healthcare delivery through innovative products and solutions, striving to create healthier futures for all.

📋 Description

• Recognize Adverse Event (AE), Adverse Drug Reaction (ADR), Adverse Drug Experience (ADE), and Medical Device Incident (MDI) information from source documents • Process Individual Case Safety Reports (ICSRs) according to applicable SOPs and Work Instructions • Perform triage, duplicate searches, data entry, MedDRA coding, narrative writing, medical evaluation, seriousness, expectedness, causality, and reportability assessments • Complete expedited and periodic submissions • Perform literature reviews • Prepare and/or review aggregate reports, including ASR, IRSR, PSURs, PBRERs, PADERs, and DSURs • Perform signal detection • Prepare and/or update Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and associated documents • Act as a client contact point • Work with internal and external stakeholders to obtain additional information or clarification • Assist with audit preparation • File and store documents according to applicable SOPs and Work Instructions • Perform other tasks assigned by the Manager • Participate in standby/on-call duties when required

🎯 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 • Certification in regulatory affairs, quality management, compliance, or auditing preferred • Ability to recognize Adverse Event (AE), Adverse Drug Reactions (ADR), Adverse Drug Experience (ADE), and Medical Device Incident (MDI) information • Knowledge of Individual Case Safety Report (ICSR) processing, including triage, duplicate search, data entry, MedDRA coding, narrative writing, medical evaluation, seriousness, expectedness, causality, reportability, expedited and periodic submissions • Ability to perform literature reviews according to applicable SOPs and Work Instructions • Experience preparing or reviewing aggregate reports, including ASR, IRSR, PSUR, PBRER, PADER, and DSUR • Ability to perform signal detection • Ability to prepare or update Risk Management Plans (RMP) or Risk Evaluation and Mitigation Strategies (REMS) and associated documents • Ability to work with internal and external stakeholders to request additional information or clarification • Ability to assist in audit preparation and file/store documents according to applicable SOPs and Work Instructions • May be required to be on standby/on-call

🏖️ Benefits

• 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 • On-call/standby compensation or arrangement may apply, but no specific additional compensation is stated