Scientific Advisor, Drug Safety

Pharmascience

. Contribute to a variety of pharmacovigilance and medical affairs activities .

Posted 10/28/2026full-timeMontréal • CanadaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance and medical affairs, with a strong focus on regulatory compliance, risk management, and safety data analysis. Proficient in bilingual communication and collaboration across departments to enhance pharmacovigilance practices.

Highest-signal resume keywords

Pharmacovigilance ExpertiseRegulatory ComplianceRisk Management PlansBilingual CommunicationSafety Data Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceRisk ManagementSafety Data AnalysisSignal DetectionRegulatory SubmissionsDocument PreparationPharmaceutical RegulationsTraining Program DevelopmentProcess ImprovementPharmacological Expertise

Soft Skills

Excellent Communication SkillsLeadership SkillsInterpersonal SkillsAnalytical SkillsCustomer-Focused

Tools & Technologies

Adobe AcrobatSharePointMicrosoft OfficeExcel

Industry Keywords

Pharmaceutical IndustryGood Pharmacovigilance PracticesHealth AuthoritiesCanadian RegulationsU.S. FDA RegulationsEU Regulations

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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