Drug Safety and Medical Information Coordinator
7 days ago
The Drug Safety and Medical Information Coordinator supports the Drug Safety and Medical Information (DSMI) team in the performance of the daily duties related to the management of medical information inquiries, product quality complaints and adverse event reporting. The Coordinator is also expected to assist with recurring administrative activities inherent to the department. The primary objective of this role is to ensure the support to the team that’s going to assure their success and the achievement of Duchesnay Pharmaceutical Group’s goals.
**Duties & Responsibilities**
- Triage incoming phone calls and answer customer service-related inquiries in accordance with established FAQ and SRD;
- Escalate unresolved inquiries to DSMI team members for handling;
- Contribute to creating and/or updating FAQ and SRD as they relate to customer service inquiries;
- Perform initial medical information inquiry, product quality complaint and/or adverse event case processing activities, namely for initial case registration and/or data entry (case “book-in” in the safety database). Is called upon to perform duties such as full case data entry in the safety database, quality assurance of case data entry, and/or individual safety case transmission activities to health authorities and/or partners (if professional background and experience permits);
- Assist DSMI personnel in the execution of the Pharmacovigilance Quality Program (e.g., digital media tracking and testing, phone line testing, medical information and/or pharmacovigilance reconciliations, external audit logistics, pharmacovigilance training logistics and tracking, gathering and/or managing metrics on team performance indicators, etc.);
- Assist DSMI personnel with any other administrative task required to fulfill departmental objectives and/or ensure departmental performance and compliance, i.e.:
- Prepare and/or create reports, presentations, written communications
- Organize meetings and document meeting summaries
- Contribute to the development and maintain the team’s network system filing structure
- Provide support as required for health authority safety inspections and partner audits;
- Contribute as required to computerized system validation projects (e.g., test script execution);
- Be compliant with product quality (i.e. ISO 13485 standard and regulation on medical devices);
- Perform any other task related to the function.
**Key skills**
- Resourceful and insightful;
- Excellent communication, documentation, organizational and interpersonal skills;
- Thoroughness;
- Ability to adapt and be flexible;
- Ability to maintain healthy work relationships with fellow employees.
**Qualifications**
- Technical Degree (in Health Science field an asset);
- Minimum of 2 years of previous experience in a regulated industry (pharmaceutical industry, an asset);
- Knowledge of Medical Information/Drug Safety databases, in particular, Scimax-MI and/or ARGUS, asset;
- Proficient Microsoft Office;
- Bilingual (English/French).
**Benefits**:
- Casual dress
- Company pension
- Dental care
- Disability insurance
- Employee assistance program
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Vision care
- Wellness program
Schedule:
- Day shift
- Monday to Friday
Work Location: Hybrid remote in Blainville, QC J7C 5E2
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