Closed listing
Drug Safety Associate
- Toronto, ON, Canada
Full-time
This opening has closed.
The original listing is kept below for reference.
Job details
- Job type
- Full-time
- Closing date
- Experience
- 1-3 years experience in Medical Information, Clinical Research or Drug Safety or equivalent and related experience in pharmacy or pharmaceutical fields.
- Posting language
- English
- Posted
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Search current openingsOriginal job description
Archived listing. The details below describe a past opening.
Job Details
This role is in support of Cencora’s patient and provider support and pharma commercialization services in Canada marketed through our Innomar Strategies business.
Responsibilities
- Receive, scan and document all pertinent clinical information in compliance with SOP/protocol and applicable legislation
- Work directly with internal and external clients to request additional information or clarification as necessary; Review of source data documents (includes visit report/PIR review) and triaging adverse event information and product, quality complaints as per client needs;
- Data entry and submission of adverse event information and product quality complaints into program specific databases.
- Sorting and filing of incoming documents.
- Perform quality check on adverse event reports as directed by the work instructions
- Assist with and/or perform source data verification checks
- Screening medical and scientific literature for safety information
- Preparation of Reconciliation (weekly, monthly etc.) reports, transcription translations and redaction activities.
- Preparation and conducting solicited follow-up letters and data clarifications.
- Assist and participate in the non-conformance/CAPA process.
- The Drug Safety Associate will also be assigned other duties and tasks as required from time to time.
- Minimum college level education required. A diploma or degree with a concentration in Life Sciences is a strong asset.
- 1-3 years experience in Medical Information, Clinical Research or Drug Safety or equivalent and related experience in pharmacy or pharmaceutical fields.
- Knowledge of Pharmacovigilance industry including up to date knowledge of; pharmacovigilance guidelines of Health Canada, US FDA, EMEA and ICH.
- Adaptability to change and to learn new skills as required
- Experience in the medical and/or pharmaceutical field(s), medical terminology is an asset.
- Bilingual, English/French is an asset.
- Strong analytical skills.
- Ability to communicate effectively both orally and in writing.
- Effective interpersonal skills.
- Effective organizational skills; ability to multitask
- Superior, proven attention to detail
- Ability to consistently meet deadlines
- Excellent problem-solving skills; ability to communicate and/or resolve issues effectively and efficiently.
- Computer skills (including knowledge of Microsoft Word, Excel, PowerPoint and other Office Programs)
- Good internet required for remote work.
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 hrsc@cencora.com. 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.
This posting is intended to fill an existing vacancy for our Drug Safety Associate role.
Affiliated Companies
Affiliated Companies: Innomar Strategies
More about this job
Responsibilities
Receive, review, document, and enter clinical safety information, adverse events, and product quality complaints in accordance with applicable procedures and regulations. Coordinate follow-ups and data clarifications, conduct quality checks and source data verification, screen medical literature, prepare reconciliation reports, and support non-conformance and CAPA processes.
Requirements
A minimum college-level education is required; a Life Sciences diploma or degree is an asset. The role seeks 1–3 years of related experience in medical information, clinical research, drug safety, pharmacy, or pharmaceuticals, along with pharmacovigilance knowledge, strong communication and analytical skills, attention to detail, and Microsoft Office proficiency.
Skills
- Pharmacovigilance
- Adverse Event Triage
- Product Quality Complaint Processing
- Clinical Information Documentation
- Medical Literature Screening
- Source Data Verification
- Data Entry
- Quality Checks
- Reconciliation Reporting
- Medical Terminology
- Analytical Skills
- Written and Oral Communication
- Organization and Multitasking
- Attention to Detail
- Problem-Solving
- Microsoft Office
Benefits
- Medical Insurance
- Dental Insurance
- Vision Care
- Backup Dependent Care
- Adoption Assistance
- Infertility Coverage
- Family Building Support
- Behavioral Health Support
- Paid Parental Leave
- Paid Caregiver Leave
- Training Programs
- Professional Development
- Mentorship Programs
Visa sponsorship
Not detected in the job text
Categories
- Healthcare
- Science & Research
- Data & Analytics
- Administrative
Keywords
- Drug Safety
- Pharmacovigilance
- Health Canada Guidelines
- US FDA Guidelines
- EMA Guidelines
- ICH Guidelines
- Adverse Events
- Product Quality Complaints
- Clinical Information
- Medical Information
- Clinical Research
- Source Data Documents
- Source Data Verification
- Medical Literature Screening
- Safety Information
- Reconciliation Reports
- Data Clarification
- Transcription
- Translation
- Redaction
- Non-Conformance
- CAPA
- Standard Operating Procedures
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Medical Terminology