Reporting to the Pharmacovigilance Lead, the Bilingual Pharmacovigilance Specialist is responsible for managing the collection, processing and reporting of Adverse Events (AEs) for the Patient Support Program.
He / she will also ensure compliance with National and Global Pharmacovigilance requirements, represent the Pharmacovigilance (PV) Department at Bayshore meetings both internally and externally as needed, and assist with all audits.
Duties and Responsibilities
Review PV reports from both Single Point of Contacts , Reimbursement Specialists and Pharmacy Team for accuracy
Enter all PV reporting into CRM as directed
Forward PV reports to Drug safety
Help develop and implement CAPAs to ensure compliance with program requirements
Complete QMRs for late PV reporting
Report and document Adverse Events as per Pharmacovigilance requirements
Assist with updating internal PV policies, SOPS and work instructions as needed
Attend / Dial Into weekly meetings with the Liaison Patient Support Program team
Assist with delivering program specific AE / PV training to new members of the team
Collaborate and interact with Pharmacovigilance team regarding new initiatives, requests for SOPs, difficult cases or Best Practices
Complete daily Kroll and CRM audits with assistance from the PV Specialist
Complete document submission for monthly client requests
Reconcile outstanding information relevant to Adverse Event reporting
Employee will maintain relevant level of knowledge of ICH (International Conference on Harmonization), GCP (Good Clinical Practice) and Health Canada GVP (Good Pharmocovigilance Practices) guidelines appropriate to their hired role which is to be provided at time of hire and annually.
With this knowledge the employee will perform the work as required by their assigned function and will be provided with regular updates as required.
Participate in processes relating to regulatory reporting requirements
Complete other tasks as requested
Knowledge of Pharmocovigilance processes and Health Canada Pharmocovigilance regulations and guidelines
Excellent written, verbal, and facilitation skills
Excellent organizational & critical thinking skills and strong and proven attention to detail
Ability to work with strict timelines and handle multiple priorities
Flexible, adaptable and able to work under pressure and convey a sense of urgency
Demonstrated initiative and accountability
Excellent customer service skills to deal with client questions, sometimes under difficult circumstances
Team Player with ability to function in a multi-disciplinary environment and promote collaboration
Proficiency with standard desktop computing programs (e-mail, Microsoft Office, etc) and relational databases.
Prior experience with Pharmacovigilance reporting software and / or safety databases applications is an asset.
Bilingualism with French and English is a requirement in this position.
STANDARDS OF PERFORMANCE
The must demonstrate ongoing competency in completing all duties and responsibilities of this job description, in response to changes by the regulating body, as well as agreed upon specific goals and objectives.
Performance will be reviewed on an ongoing basis with a formal review at the end of the three-month probationary period and subsequently, on at least an annual basis.
Input will be sought from employee, Supervisor and Field employees, and in addition, will be based on ongoing client feedback and the extent to which performance meets expectations.