Global Pharmacovigilance System Project Lead
2 weeks ago
Award-winning Pharmascience is a Canadian leader in the generic pharmaceutical industry with a growing global reach. Our team of 1,500 people involves in the production and marketing of generic prescription, over-the-counter, and pharmacist-dispensed drugs as well as injectable medicines all manufactured in Canada.
We are seeking a highly skilled Global Pharmacovigilance System & Project Lead to participate in the quality planning of our pharmacovigilance system. This includes ensuring compliance, control, and improvement while maintaining our PV system and activities aligned with Canadian and international health authority requirements and global good practices.
The successful candidate will have an in-depth knowledge of regulatory requirements for adverse reaction reporting and pharmacovigilance activities. They will also possess excellent computer skills (MS Office) and strong teamwork skills. Bilingualism in French & English is required. The salary for this position is estimated to be around $90,000 per year.
Job Description
This role will involve planning, monitoring, and coordinating global pharmacovigilance activities to ensure compliance with deadlines and health authority requirements. It will also include actively monitoring health authority regulations and guidelines for any changes or updates that may impact PV activities.
- Plan, monitor, and coordinate global PV activities to ensure compliance with deadlines and health authority requirements.
- Actively monitor health authority regulations and guidelines for any changes or updates that may impact PV activities.
- Negotiate and maintain SDEAs with partners and PV service agreements.
- Develop and maintain the Pharmacovigilance System Master File (PSMF), PV System Summaries, and contact information for global and local Qualified Persons Responsible for Pharmacovigilance (QPPV).
Required Skills and Qualifications
We are looking for a highly motivated individual who has experience in writing and reviewing PV-related documents (PSUR, RMP, SDEA, PSMF, etc.) and has knowledge of EudraVigilance. They should have a positive attitude, self-reliance, and constant concern for process improvement.
Benefits
- Paid telemedicine sessions as of day one.
- RRSP with employer contribution as of day one.
- On-site gym and training classes for free.
Others
- Flexible schedule with a hybrid work model.
- Participate in various reconciliation activities with company departments, partners, and others as required.
- Track compliance and metrics through reporting, corrective actions, and trending.
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