Drug Safety Specialist
2 weeks ago
**Job Description Summary**: Responsible for all activities related to the Global Pharmacovigilance (GPV) Central Safety Unit (CSU) processing of Individual Case Safety Report (ICSR) information from all sources including post-marketing, clinical trials and published literature. ICSR Case Processing, including but not limited to case receipt and registration, triage, data entry, quality control, and report review/submissions.
Our Pharmaceutical Diagnostics (PDX) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDX products support three patients every second around the world.
**Essential Responsibilities**:
- Receive, register, triage and process adverse event and medical device reports from all sources including post-marketing, clinical trials and published literature
- Perform initial assessment of seriousness, expectedness, causality, and reportability in accordance with GPV processes and global regulatory requirements and guidelines
- Perform data entry and quality review of adverse event reports into the global safety database, including accurate coding of MedDRA terms and preparation of case narratives
- Identify missing or discrepant information and perform active case follow-up via verbal or written contact
- Prepare expedited reports for submission to regulatory authorities and ethics committees
- Serve as pharmacovigilance liaison and resource to internal and external groups (e.g., regulatory affairs, medical affairs, clinical development teams, CROs, etc.) on issues related to pharmacovigilance
- Interface with quality assurance on product quality issues- Perform reconciliations between clinical, quality and PV databases
- Support safety physicians in handling issues related to both clinical and post-marketing safety, as needed
- Support preparation and submission of aggregate reports including PSURs, DSURs, and US Periodic Reports, as needed
- Serve as pharmacovigilance resource during inspections and audits
**Qualifications/Requirements**:
- BS (Life Sciences Background) or equivalent with minimum of 3 years of pharmaceutical/biotechnology PV case processing experience, including clinical trial and postmarketing experience. Global experience preferred.
- Proficient in all aspects of case processing, including case assessment (seriousness, expectedness, reportability), narrative writing, MedDRA coding, quality review and follow-up
- Proficient in data entry and electronic reporting in global drug safety databases
- Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines
**Desired Characteristics**:
- Healthcare professional (Nurse or Pharmacist) with clinical experience preferred
- Experience with Argus preferred
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
LI-MA4
**Additional Information**:
**Relocation Assistance Provided**:No
-
Drug Safety and Medical Information Specialist
2 weeks ago
Mississauga, Canada Bayshore HealthCare Full time**ABOUT THE ROLE**: The Drug Safety and Medical Information (DSMI) Specialist is responsible for managing and overseeing the collection, processing, quality check and reporting of Safety events (Adverse Events and/or Product Quality Complaints) and handling Medical Information (MI) inquiries. The incumbent will represent the Scientific Affairs Department at...
-
Mississauga, Canada Bayshore HealthCare Full time**ABOUT THE ROLE**: Drug Safety and Medical Information (DSMI) Specialist is responsible for managing and overseeing the collection, processing, quality check and reporting of Safety events (Adverse Events and/or Product Quality Complaints), and handling Medical Information (MI) inquiries. The incumbent will represent the Scientific Affairs Department at...
-
Mississauga, Canada Bayshore HealthCare Full timeThe Bilingual Drug Safety and Medical Information (DSMI) Specialist is responsible for managing and overseeing the collection, processing, quality check and reporting of Safety events (Adverse Events and/or Product Quality Complaints) and handling Medical Information (MI) inquiries. The incumbent will represent the Scientific Affairs Department at Bayshore...
-
Drug Safety Mailbox Admin
21 hours ago
Mississauga, Canada Bayshore HealthCare Full time**SUMMARY**: The incumbent will represent the Scientific Affairs Department at Bayshore Specialty Rx, both internally and externally and be instrumental in ensuring compliance with Pharmacovigilance Contractual Obligations, Canadian Adverse Event reporting guidelines, Good Pharmacovigilance practices and Medical Information practices. **DUTIES AND...
-
Drug Safety and Medical Information Coordinator
20 hours ago
Mississauga, Canada Bayshore HealthCare Full time**ABOUT THE ROLE** The Drug Safety and Medical Information (DSMI) Coordinator (Floater) is responsible for managing AE/PV inbox and supporting the collection, processing, quality check and reporting of Safety events (Adverse Events and/or Product Quality Complaints), and handling Medical Information (MI) inquiries. The incumbent will represent the Scientific...
-
Bilingual Drug Safety and Medical Information
20 hours ago
Mississauga, Canada Bayshore HealthCare Full time**ABOUT THE ROLE** The Bilingual Drug Safety and Medical Information (DSMI) Coordinator (Floater) is responsible for managing AE/PV inbox and supporting the collection, processing, quality check and reporting of Safety events (Adverse Events and/or Product Quality Complaints), and handling Medical Information (MI) inquiries. The incumbent will represent the...
-
Patient Care Specialist
9 hours ago
Mississauga, Ontario, Canada Shoppers Drug Mart Full timeLocation: 1685 Tech Ave, Mississauga, Ontario, L4W 0A7At Shoppers Drug Mart, we're innovating health and wellness in Canada. From prescriptions to walk-in clinics, and a beloved loyalty program, we're caring and supporting our customers in new ways every day.With more than 1,300 locally owned and operated stores from coast to coast, the Shoppers Drug Mart...
-
Patient Care Specialist
2 weeks ago
Mississauga, Canada Shoppers Drug Mart Pharmaprix Full time**Location**: 1685 Tech Ave, Mississauga, Ontario, L4W 0A7 At Shoppers Drug Mart, we’re innovating health and wellness in Canada. From prescriptions to walk-in clinics, and a beloved loyalty program, we’re caring and supporting our customers in new ways every day. With more than 1,300 locally owned and operated stores from coast to coast, the Shoppers...
-
Specialist, Patient Care
4 days ago
Mississauga, Canada Shoppers Drug Mart Pharmaprix Full time**Location**: 1685 Tech Ave, Mississauga, Ontario, L4W 0A7 At Shoppers Drug Mart, we’re innovating health and wellness in Canada. From prescriptions to walk-in clinics, and a beloved loyalty program, we’re caring and supporting our customers in new ways every day. With more than 1,300 locally owned and operated stores from coast to coast, the Shoppers...
-
Patient Care Specialist
1 week ago
Mississauga, Canada Shoppers Drug Mart Pharmaprix Full time**All referred applicants must first be submitted through Workday by a current Loblaw Colleague.**: **Location**: 1685 Tech Ave, Mississauga, Ontario, L4W 0A7 Take ownership and find more ways to care about our local store owners in a career at Shoppers Drug Mart Central Office / Store Support. Provide great service, specific expertise and actionable advice...
