Pharmacovigilance Analyst

AmerisourceBergen; Oakville; On-site; CAD 70,000 - 90,000; Full time

Job summary

An innovative healthcare company is seeking a qualified individual to join their Pharmacovigilance team in Oakville. This full-time role involves ensuring compliance with safety reporting regulations, conducting literature reviews, and collaborating with clients and stakeholders to enhance patient safety. Successful candidates will possess strong analytical and communication skills, along with a proven background in the pharmaceutical industry.

Benefits

Comprehensive health benefits

Training programs

Professional development resources

Volunteer activities

Qualifications

• Bilingual, English/French strongly preferred.
• 3-4 years of experience in Pharmacovigilance.
• Strong knowledge of pharmacovigilance industry regulations.

Responsibilities

• Process Individual Case Safety Reports (ICSR) according to SOPs.
• Conduct literature reviews and prepare aggregate reports.
• Act as a contact point for clients and internal stakeholders.

Skills

Analytical skills

Interpersonal skills

Problem-solving skills

Organizational skills

Communication skills

Leadership skills

Education

Bachelor’s degree in Pharmacy, Dental, Pharmacology, Nursing, or Medical Degree

Tools

MS Office Suite

Adobe Pro

Job description

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!

Primary Duties and 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.

Experience and Educational Requirements:

• Bilingual, English/French strongly preferred
• Bachelor’s degree in a Pharmacy, Dental, Pharmacology, Nursing, or Medical Degree
• 3-4 years of experience in the Pharmacovigilance area of the pharmaceutical industry; Knowledge of medical terminology is a strong asset

Minimum Skills, Knowledge and Ability Requirements:

• 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

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

Full time

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!

Job Details

Primary Duties and 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.

Experience and Educational Requirements:

• Bilingual, English/French strongly preferred
• Bachelor’s degree in a Pharmacy, Dental, Pharmacology, Nursing, or Medical Degree
• 3-4 years of experience in the Pharmacovigilance area of the pharmaceutical industry; Knowledge of medical terminology is a strong asset

Minimum Skills, Knowledge and Ability Requirements:

• 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

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

Full time

Equal Employment Opportunity

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 membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [e-mail] . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Accessibility Policy

Cencora is committed to fair and accessible employment practices. When requested, Cencora will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.

Affiliated Companies:

Affiliated Companies: Innomar Strategies

About the company

AmerisourceBergen Corporation is an American drug wholesale company that was formed by the merger of Bergen Brunswig and AmeriSource in 2001.

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