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Pharmacovigilance Associate

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Cencora

Sep 6, 2024

  • Job
    Full-time
    Junior Level
  • Science
    Healthcare
  • Oakville
  • Quick Apply

AI generated summary

  • You must be bilingual (English/French), have a Bachelor’s in life sciences, 1-2 years in pharmacovigilance, knowledge of regulations, good analytical skills, and effective communication.
  • You will process adverse event reports, conduct literature reviews, manage communications, reconcile data, prepare for audits, file documents, and support stakeholders as needed.

Requirements

  • Bilingual, English/French strongly preferred
  • 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; Knowledge of medical terminology is a strong asset
  • 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

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 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 filling 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

FAQs

What is the primary focus of the Pharmacovigilance Associate role at Cencora?

The primary focus of the Pharmacovigilance Associate role is to recognize and process Adverse Events (AEs), Adverse Drug Reactions (ADRs), and related information while ensuring compliance with applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs).

Is bilingualism required for this position?

Yes, being bilingual in English and French is strongly preferred for this role.

What educational background is required for this position?

A Bachelor’s degree in a life sciences program is required for the Pharmacovigilance Associate role.

How much experience is needed for this role?

The role requires 1-2 years of experience in Pharmacovigilance, Medical Information, Clinical Research, or equivalent related experience in the pharmaceutical industry.

What key skills are necessary to be successful in this position?

Essential skills include strong knowledge of the pharmacovigilance industry, familiarity with medical terminology, effective communication abilities, analytical and problem-solving skills, and strong organizational skills.

What tools or software should candidates be familiar with?

Candidates should be familiar with MS Word, MS Excel, MS PowerPoint, other MS Office Programs, and Adobe Pro. Knowledge of Good Documentation Practice (GDP) and Quality Management Systems (QMS) is also an asset.

What benefits does Cencora offer to its employees?

Cencora offers a comprehensive suite of benefits including medical, dental, and vision care, support for working families, personal growth training programs, and resources focused on physical, emotional, financial, and social wellness.

Are there opportunities for professional development within the company?

Yes, Cencora provides various training programs, professional development resources, mentorship opportunities, and chances to participate in employee resource groups and volunteer activities.

What is the expected work schedule for this role?

The position is full-time, and candidates should be able to work any 8-hour shift between 8:00 AM and 8 PM, if necessary.

Does Cencora have an equal employment opportunity policy?

Yes, Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or any class protected by law.

How does Cencora accommodate individuals with disabilities?

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process. Requests for accommodations can be made by calling 888.692.2272 or emailing hrsc@cencora.com.

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Cencora

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Cencora, a company building on the legacy of AmerisourceBergen, is a leading global pharmaceutical solutions organization centered on improving the lives of people and animals around the world. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We also help our partners bring their innovations to patients more efficiently to accelerate positive outcomes. Becoming Cencora has allowed us to combine all the companies and services of AmerisourceBergen. Now, as a unified and internationally inclusive brand, we’re continuing to invest in and focus on our core pharmaceutical distribution business, while also growing our platform of pharma and biopharma services to support pharmaceutical innovation and access. Our 46,000+ worldwide team members are shaping the future of healthcare through the power of our purpose: We are united in our responsibility to create healthier futures.