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, fabricant de médicaments pour patients au Canada et dans plus de 50 pays. Analyse des signaux de sécurité et coordination des soumissions réglementaires.
Responsibilities
- Contribute to various pharmacovigilance and medical affairs activities
- Provide medical and scientific advice and prepare responses to requests from health authorities or other departments
- Draft and prepare pharmacovigilance documents, including risk management plans, Canadian addenda, SVAF forms, and safety-related documents
- Ensure documents comply with regulatory requirements and guidelines
- Create and update training programs for PV personnel
- Support the PV Operations team with aggregate and issue-related reports
- Provide medical, pharmacovigilance, and epidemiological expertise
- Serve as the signal detection champion and subject matter expert
- Coordinate and participate in signal detection meetings
- Proactively monitor observations and notifications of potential signals
- Analyze and interpret safety data to identify signals and trends
- Assess the need to update official labeling based on safety signals
- Support initiatives to improve the signal detection process
- Notify Health Canada or other health authorities of actions taken abroad regarding serious risks
- Prepare risk management plans, Canadian addenda, and additional risk minimization measures for regulatory submissions
- Provide regular updates 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 RMP/ RMM needs and maintain follow-up
- 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 for HRAs
- Draft and update standard operating procedures and local work instructions
- Support and participate in pharmacovigilance audits and inspections
- Participate in PV and medical affairs process improvement initiatives
Requirements
- Bilingual in spoken and written French and English
- Strong knowledge of the pharmaceutical industry and regulatory requirements for 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 as part of a team, with excellent leadership and interpersonal skills
- Proactive, customer-focused, solutions-oriented, flexible, and analytical
- Strong work ethic
- Detail- and quality-oriented, with the ability to continuously identify ways to improve processes and practices
- Three to five (3–5) years of pharmacovigilance experience
- Experience with Canadian, U.S. FDA, EU, or other jurisdictional PV regulations and good pharmacovigilance practices is an asset
- University degree in Health Sciences or a related field; PharmD, MD, nursing, PhD, or master’s degree preferred, or equivalent experience
- Bachelor’s degree in Medicine or a related field
- Bachelor’s degree in Pharmacy or a related field
- Bachelor’s degree in Nursing or a related field
Benefits
- Annual performance bonus
- Internal employee 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
- On-site gym
Job title
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Experience level
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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.