Pharmacovigilance Analyst - Oakville, ON, Canada - Innomar Strategies

Description

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Pharmacovigilance Analyst

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

What you will be doing 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.

What your background should look like 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.

Schedule

Affiliated Companies:

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.

AmerisourceBergen 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 or email . 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

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

About Us

Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them.

We're a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health.

Job Scams

Recruitment scams are on the rise and the intent is to target individuals looking for employment opportunities. To protect yourself, we urge you to be vigilant and follow these guidelines.

1.) Research the Company: Thoroughly research any company before applying or sharing personal information, check their website, read reviews, and verify their legitimacy.

2.) Be Wary of Unrealistic Promises: Exercise caution If a job posting offers high salaries and minimal qualifications. Legitimate jobs will have realistic expectations and provide detailed job requirements. Jobs at Cencora can be found on

3.) Guard Your Personal Information: Only share sensitive information after vetting the employer's credibility. Avoid sharing your Social Security number, bank account details, or identification documents during the application process. Cencora does not request this information as part of the employment application.

4.) Avoid Upfront Payments: Legitimate employers do not require payment during the hiring process. Be suspicious if you are asked to pay for training materials, processing fees, or background checks before securing a job offer. Cencora will never ask you for payment information during the hiring or onboarding process.

5.) Verify Communication Channels: Scammers often use free email services or chat platforms without providing an official company contact information. Cencora recruiters will have an email address ending in , @alliance-, @alliance-, alliance- or alliance-

Remember to stay vigilant and informed about common scam tactics to reduce the risk of falling victim to fraudulent employment schemes.