Drug Safety Mailbox Admin

2 weeks 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 RESPONSIBILITIES**:

- Identify, triage, and route all incoming safety communication (internal and external) to the appropriate drug safety team members as per program/product assignment.
- Assess date of awareness and assign due date of all incoming drug safety reports.
- Assign safety cases to team members as per program/product alignment.
- Review safety source documents and conduct follow-up for additional information from the initial reporter and fill in gaps as necessary.
- Assist the Drug Safety and Medical Information (DSMI) team with CRM data entry as needed.
- Assist the DSMI team with other Pharmacovigilance related duties as needed.
- Support with PV audit requests.
- Build excellent rapport with the internal and external customers.
- Complete other departmental tasks as assigned.

**GENERAL DUTIES AND RESPONSIBILITIES**:

- Maintains confidentiality of patient, client, and corporate information at all times.
- Employee will maintain relevant level of knowledge of GDP (Good Documentation Practices), Health Canada GVP (Good Pharmacovigilance Practices), Health Canada Adverse Event Reporting guidelines, as appropriate to their hired role which is to be provided at time of hire and on an as needed basis. With this knowledge the employee will perform the work as required by their assigned function and will be provided with regular updates as required.
- Adheres to Bayshore’s Policies and Procedures.

Job Qualification

EDUCATION:
Minimum Requirements - High School Diploma or Post High School Certification or College Diploma.

EXPERIENCE- Experience in Pharma or Healthcare setting.
- Knowledge of local Pharmacovigilance requirements and principles.
- Knowledge of Health Canada guidelines on Reporting Adverse Reactions for Marketed Health Products.

OTHER SKILLS AND ABILITIES:
- Excellent written and verbal communication skills.
- Excellent organizational skills and attention to detail.
- Flexible, adaptable, and able to work under pressure.
- Demonstrated initiative and accountability and be able to work under mínimal supervision.
- Excellent customer service skills - ability to handle internal and external stakeholder queries.
- Team Player with ability to function in a multi-disciplinary environment and promote collaboration.
- Proficiency with Microsoft Office suite (Outlook, Word, Excel and PowerPoint).



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