Scientific Advisor, Drug Safety

Pharmascience

. Contribute to various 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, signal detection, and safety data analysis. Proficient in drafting risk management plans and collaborating across departments to enhance pharmacovigilance practices.

Highest-signal resume keywords

Pharmacovigilance ExperienceRegulatory ComplianceSignal Detection ExpertiseBilingual in French and EnglishHealth Sciences Degree

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceRisk Management PlansSafety Data AnalysisSignal DetectionRegulatory SubmissionsPharmaceutical RegulationsGood Pharmacovigilance PracticesDocument PreparationTraining Program DevelopmentProcess Improvement

Soft Skills

Excellent Communication SkillsLeadership SkillsInterpersonal SkillsAnalytical SkillsCustomer-Focused

Tools & Technologies

Adobe AcrobatSharePointMicrosoft OfficeExcel

Industry Keywords

Pharmaceutical IndustryHealth AuthoritiesCanadian RegulationsU.S. FDA RegulationsEU Regulations

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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