Selbstständige Ernährungsberatung für Hunde und Katzen bei Tierfutterhersteller ANIfit. Beratung zur Tierernährung und Unterstützung bei Futterumstellungen mit Lifetime - Provisionen.
About the role
- Conseiller scientifique en pharmacovigilance chez Pharmascience, qui développe et fabrique des médicaments pour améliorer la santé des patients. Coordination de la détection des signaux, des plans de gestion des risques et des soumissions réglementaires.
Responsibilities
- Contribute to a variety of pharmacovigilance and medical affairs activities
- Provide medical and scientific advice and prepare responses to inquiries from health authorities or other departments
- Draft and prepare pharmacovigilance documents, including risk management plans, Canadian addenda, SVAF forms, and various safety-related documents
- Ensure documents comply with regulatory requirements and guidelines
- Create and update training programs for pharmacovigilance personnel
- Support the PV Operations team with aggregate summary reports and issue-related reports
- Provide medical, pharmacological, pharmacovigilance, and epidemiological expertise
- Coordinate signal detection meetings and participate as a core member of the working group
- Ensure signal detection activities comply with regulatory requirements
- Analyze and interpret safety data to identify potential signals and trends
- Assess the need to update official labeling based on safety signals
- Monitor and notify Health Canada or other health authorities of actions taken abroad concerning serious risks
- Prepare risk management plans, additional risk minimization measures, and regulatory submissions
- Provide updates on document status and ensure documents are prepared and submitted on time
- Collaborate with Marketing, Regulatory Affairs, and other departments
- Coordinate vendor activities, document preparation, and submissions
- Update RMP data and information related to commitments
- Assess the need for RMPs and additional risk minimization measures and maintain follow-up activities
- Participate in RMP lifecycle monitoring and periodic reviews
- Contribute to the safety sections of new submissions
- Train and support internal teams on pharmacovigilance practices and safety monitoring
- Provide scientific and medical input to HRAs
- Draft and update standard operating procedures and local work procedures
- Support and participate in pharmacovigilance audits and inspections
- Participate in pharmacovigilance and medical affairs process improvement initiatives
Requirements
- Bilingual in spoken and written French and English
- Strong knowledge of the pharmaceutical industry and regulatory requirements applicable to all aspects of pharmacovigilance activities
- Excellent oral and written communication skills
- Proficiency with Adobe Acrobat, SharePoint, and Microsoft Office, including Excel
- Ability to work independently, prioritize and manage multiple tasks, and meet tight deadlines
- Experience in an international pharmaceutical environment is an asset
- Ability to work effectively in a team, with excellent leadership and interpersonal skills
- Proactive, customer-focused, solution-oriented, flexible, and analytical
- Strong work ethic
- Detail- and quality-oriented, with the ability to continually identify ways to improve processes and practices
- Three to five (3–5) years of experience in pharmacovigilance
- Experience with Canadian, U.S. FDA, EU, or other jurisdictions’ pharmacovigilance regulations and good pharmacovigilance practices is an asset
- University degree in Health Sciences or a related field, preferably a PharmD, MD, nursing degree, PhD, or master’s degree, or equivalent experience
Benefits
- Annual performance bonus
- Internal referral program offering up to $3,000
- Vacation and personal days available from the date of hire
- Group insurance coverage from day one, including telemedicine
- Competitive retirement plan with employer contributions from day one
- Employee assistance program
- Continuing education opportunities
- Stimulating and collaborative work environment
- On-site parking
- Gym
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Report this job
Found something wrong with the page? Please let us know by submitting a report below.
Aircraft powerplant advisor training and mentoring international military aviation teams. Supporting Resicum International’s U.S. Government Foreign Military Sales aviation programs worldwide.
Senior HSEQ Advisor supporting Sedgman’s complex mineral processing projects across North America. Strengthening HSEQ systems, risk management, audits and project delivery across the Americas.
Part - time remote Service Advisor using trade knowledge to scope homeowner jobs, explain pricing, and book Microworks technicians. Weekend schedule with growth toward full - time work.
Client Relationship Advisor promoting LiveHappy Initiative’s leadership and personal development programs. Building prospective - client relationships through digital marketing, conversations, and follow - up.
HS&E Advisor implementing health and safety programs across Ledcor’s heavy civil and mining projects. Conducting inspections, audits, training, and incident investigations at site - based locations.
Senior business strategy advisor developing business strategies and intelligence for Desjardins. Leading complex transformation initiatives and advising senior management across Montréal and Lévis.
Total compensation advisor developing salary structures, surveys, and benefits programs for Desjardins. Analyzing compensation data and advising stakeholders on HR solutions.
Catastrophic Claims Advisor guiding Ontario clients through complex accident benefits claims at Desjardins. Coordinating recovery, legal, medical, and rehabilitation stakeholders while negotiating fair claim resolutions.
Conseiller scientifique en pharmacovigilance chez Pharmascience, fabricant de médicaments pour patients au Canada et dans plus de 50 pays. Analyse des signaux de sécurité et coordination des soumissions réglementaires.