Pharmacovigilance Specialist – ref. 228PV-HP
The Pharmacovigilance Specialist is needed in Montreal who will be responsible for:
• Maintaining an efficient vigilance system in compliance with the Health Canada regulations and guidelines Participating in other Pharmacovigilance processes (e.g., Post-market surveillance activities / Clinical trial activities / Training)
• Ensuring appropriate contacts with Regulatory Affairs, Quality, Medical Affairs, and Global Pharmacovigilance.Post-market surveillance activities:
• To collect, pursue follow-up information to complete quality adverse event reports and transmit all local adverse events to Global Pharmacovigilance.
• To document and update case information into the global safety database.
• Analyze and process adverse events and safety reports with utmost quality and timeliness in accordance with Global and Local Pharmacovigilance procedures.
• To respond to queries and requests from Global Pharmacovigilance.
• Interact with other functional areas/departments to process adverse events efficiently & reliably.
• To submit the reportable adverse reactions to Health Canada according to their regulations and guidances
• To provide responses to questions from Health Canada and Health Care Professionals regarding adverse events cases.
• To collaborate in developing and maintaining the local Pharmacovigilance SOPs and procedures.
• To review and submit Summary Reports to Health Canada according to their regulations and guidances
• To provide Pharmacovigilance input into labeling changes in conjunction with the Regulatory Affairs Department.
• To have at disposal an updated list of all Canadian drug licensing status and renewals, in conjunction with Regulatory Affairs.
• To identify all local safety observational studies (-e.g., Phase IV studies), in conjunction with Regulatory Affairs.
• To review and provide input into local contracts with third partners (licensing, distributor, etc.), in conjunction with Global Pharmacovigilance and maintain an updated list.Clinical trials activities:
• To submit reportable adverse reactions to applicable divisions of Health Canada according to their regulations and guidances.
• To inform Global Pharmacovigilance on all new local clinical trials and transmit the protocol if applicable.
Local regulations:
• To maintain current knowledge of all relevant local Pharmacovigilance regulations in regards to human and veterinary drugs and biological products
• To participate in the screening of Health Canada’s website in conjunction with Regulatory Affairs.
• To educate internal stakeholders on the implications of existing regulations and guidance documents along with local and global procedures and policies.
• Coordinate responses to questions and requests from Regulatory Authorities
Requirements:
• Science degree (Pharmacy or MD Required)
• 2-5 years Canadian Pharmacovigilance, Quality or Regulatory experience
• Capable of multi-tasking,
• Above average computer skills.
• Excellent organizational and communication skills with multiple audiences (e.g., Health Canada, internal departments, Health Care Professionals and patients).
• Operates effectively in a team environment
• Ability to work under strict deadlines and changing priorities with limited supervision
• Attention to detail
• Understanding of existing regulations and guidance
• Must be bilingual (English, French)
Our tip: The person applying should be quick to learn databases, very attentive to detail and get along with people. The job contains a lot of clerical duties and that should be also understood. Foreign MDs or pharmacists can be eligible if the CV is adapted appropriately. Join our Job Insertion program to get unlimited CV adaptation and interview preparation support and recommendations to hiring companies.
Pharmacovigilance Coordinator – ref. 218PV-HP
A reputable international pharmaceutical company in Montreal is seeking a dedicated Pharmacovigilance Coordinator to join team. They are offering a competitive compensation package, a collaborative work environment and an excellent work/life balance. Apply now if you are interested in this exciting and challenging full-time contract position.
Job description
- Forward Individual Case Safety Reports (ICSR) of all types (initial, follow-up, serious, non-serious, solicited, non solicited, drug, medical device) to the GPE (Global Pharmacovigilance and Epidemiology) or licensed partners as per corporate and local requirements and timelines.
- Process CIOMS reports received from GPE for domestic and international cases in preparation for evaluations by PV specialists.
- Following evaluations by PV specialists, process reports for submitting to Health Canada.
- Ensure that all ICSRs for drugs and medical devices subject to expedited reporting according to Canadian regulations are submitted to Health Canada within prescribed timelines. PV specialists will identify such ICSRs as well as deadlines.
- Prepare written follow-up requests for ICSRs as per corporate and local requirements.
- Document in the local PV tracking database (Remedy) all activities related to Canadian ICSRs and international reportable ICSRs.
- Process medical device ICSRs and PTCs (Product Technical Complaints) as per local and corporate requirements, including ICSRs from the Lantus Pen Call Centre. Maintain paper and electronic filing of such activities, including data entry in the local PV tracking database.
- Maintain paper files for all PV activities as per Canadian and corporate requirements and according to GDP (Good Documentation Practices).
- Maintain an accurate and efficient electronic filing system for all PV activities to ensure efficient functioning of the team.
- Participate in the administration of the PV tracking database (Remedy) including modifications, corrections, and adjustments for continuous improvement of the system.
- Participate in the development of quality documents (e.g ‘’working documents’’) describing the technical steps of coordinator activities.
Provide overall support to the PV team, including the PV Head and PV specialists, on all team activities.
Requirements:
• Science degree (BSc.), (Preferred: BSc. Biology, Pharmacology; Nursing, Pharmacy)
• 2-5 years Canadian Pharmacovigilance, Quality or Regulatory experience
• Capable of multi-tasking,
• Above average computer skills.
• Excellent organizational and communication skills with multiple audiences (e.g., Health Canada, internal departments, Health Care Professionals and patients).
• Operates effectively in a team environment
• Ability to work under strict deadlines and changing priorities with limited supervision
• Attention to detail
• Understanding of existing regulations and guidance
• Must be bilingual (English, French)
Our tip: For that job, the person has to be also quick with computers and able to have ”many irons on the fire” simultaneously. Deadlines and compliance are key elements, so the person has to be able to keep up a certain speed and be still very attentive to details and remain polite and professional with colleagues, as everyone is under the same pressure. What matters in the end, is how well the whole team performs, not just one employee. We need to help each other and we get help from each other. We encourage qualified CRA students and members to apply.
The main data bases used in some companies are called AWARE and PRIMO, but every company may very well have internal company creations. In addition, there are other programs and applications that certainly are used in house only. What is needed is that the person has no fear of computer applications and is willing to learn them. A new employee will go through heavy training, he/she is not expected to know those programs in advance. Attitude, capability to learn and likable personality are key factors, as there will be many applicants with fitting qualifications.
Join our Job Insertion program to get unlimited CV adaptation and interview preparation support and recommendations to hiring companies.