Senior Scientist, Risk Management & Safety Surveillance

Accountabilities:

• Own and coordinate scheduled and ad hoc aggregate safety reports and analyses, ensuring timely and high-quality delivery.
• Collaborate with therapeutic area safety leaders, Medical Safety Officers, Safety Surveillance Physicians, and other stakeholders to develop safety strategies.
• Initiate, conduct, and oversee searches of internal and external safety and medical databases.
• Perform and lead aggregate safety analyses and case-level reviews, interpreting adverse drug reactions and complex safety associations.
• Author, review, contribute to, and coordinate core safety deliverables and strategic safety documents.
• Ensure pharmacovigilance commitments, including agreements and assessment reports, are fulfilled.
• Partner with external vendors to develop and deliver safety reports and related materials.
• Support Safety Management Teams and participate in assigned product safety activities.
• Provide guidance on Risk Management Plans, including development, updates, review, and alignment with oversight leads.
• Lead or support PBRER/PSUR strategies and review safety assessments in collaboration with relevant stakeholders.
• Support responses to health authority queries by organizing data, reviewing cases and literature, and preparing regulatory comments.
• Contribute to CCDS and US/EU prescribing information updates as part of label working groups.
• Lead signal validation and evaluation activities, including assessment of preliminary data and determination of appropriate follow-up.
• Support Investigator's Brochure safety updates, DSURs, clinical overviews, literature reviews, and Product Safety Strategy updates.
• Participate in Level 2 escalations and Health Hazard Evaluations, assessing potential safety impact and driving appropriate follow-up.
• Provide safety input to Clinical Development Teams, Local Working Groups, and other cross-functional meetings.
• Review regulatory assessor comments and requests and support appropriate responses.
• Participate in departmental training, cross-functional initiatives, meetings, and knowledge-sharing activities.
• Identify potential safety issues, escalate concerns appropriately, and reprioritize activities as business and safety needs evolve.

Requirements:

• Bachelor’s degree in Health Science, Biomedical Science, or a related field with 6–8 years of relevant industry experience, or an advanced degree with 4–6 years of relevant experience.
• Physicians with an MD or equivalent may qualify with approximately 2–5 years of pharmacovigilance or relevant clinical research/Medical Affairs experience.
• Clinical medicine experience, including at least 3 years of clinical practice, is preferred for physician candidates.
• Experience in pharmacovigilance, clinical/medical writing, drug safety, or a closely related discipline is preferred.
• Strong knowledge of drug development principles, benefit-risk assessment, and safety evaluation for both marketed and investigational products.
• Strong understanding of global pharmacovigilance regulations and safety requirements.
• Excellent written and verbal English communication skills.
• Strong analytical capabilities and attention to detail, with the ability to interpret safety data within a broader clinical and regulatory context.
• Demonstrated ability to understand adverse drug reactions and complex safety associations.
• Strong organizational and project coordination skills, with the ability to manage multiple deliverables and therapeutic areas.
• Ability to collaborate effectively across medical, scientific, regulatory, clinical, and external vendor functions.
• Sound scientific judgment and the ability to identify, investigate, communicate, and escalate potential safety issues.
• Flexibility and adaptability when priorities change, with the ability to work independently and effectively in a cross-functional environment.

Benefits:

• Base salary range of $80–$115 CAD.
• Permanent employment opportunity.
• Flexible and remote-friendly work environment.
• Fully covered group insurance.
• Professional development and ongoing training opportunities.
• Collaborative, quality-focused, cross-functional work environment.
• Opportunities to contribute to global pharmacovigilance and drug safety initiatives across multiple therapeutic areas.