6 дней назад
Senior Scientist, Risk Management & Safety Surveillance
80 - 115CAD
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Scientist, Risk Management & Safety Surveillance (Pharmacovigilance): Managing aggregate safety reports, risk management plans, signal evaluations, and case-level reviews for pharmaceutical products with an accent on safety strategy, regulatory compliance, and cross-functional coordination. Focus on analyzing complex adverse drug reactions, leading PBRER and signal evaluation activities, and addressing health authority and product safety requirements.
Location: Remote, Canada
Salary: $80–$115 CAD
Company
is a global full-service contract research organization providing clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.
What you will do
- Own and deliver scheduled and ad hoc aggregate safety reports and analyses.
- Plan and oversee internal and external database searches, case-level reviews, and aggregate safety assessments.
- Develop safety strategies with Therapeutic Area Safety Heads, Medical Safety Officers, Safety Surveillance Physicians, and other stakeholders.
- Lead or support Safety Management Team activities, risk management plans, PBRERs, PSURs, DSURs, and product safety strategy updates.
- Lead signal validation and evaluation, health authority query responses, and Level 2 escalation or HHE processes.
- Coordinate vendors, cross-functional contributors, regulatory responses, labeling updates, and other strategic safety documents.
Requirements
- Bachelor’s degree in Health or Biomedical Science with six to eight years of industry experience, or an advanced degree with four to six years of experience.
- Physicians may qualify with two to five years of pharmacovigilance or relevant experience; clinical practice experience of at least three years is preferred.
- Experience in pharmacovigilance, clinical or medical writing, drug development, and benefit-risk assessment.
- Knowledge of global safety regulations and safety assessment for marketed and investigational drugs.
- Strong English verbal and written communication skills are required.
- Applicants must be based in Canada for this remote position.
Nice to have
- Advanced degree in Health or Biomedical Science.
- Clinical medicine experience and demonstrated clinical practice.
- Experience with regulatory assessor comments, prescribing information updates, CCDS, IB safety sections, and literature reviews.
Culture & Benefits
- Permanent position within an in-house team.
- Remote work arrangement in Canada.
- Collaborative, quality-focused one-team culture.
- Professional development supported through continuous training and cross-functional initiatives.
- Inclusive and barrier-free recruitment and employment environment.
Hiring process
- Submit a CV and receive an application acknowledgement.
- Qualified applicants are invited to a phone interview as the first step.
- AI screening is used to review keywords and minimum qualifications, with recruiter review of results.
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