Назад
Company hidden
6 дней назад

Senior Scientist, Risk Management & Safety Surveillance

80 - 115CAD
Формат работы
remote (только Canada)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Canada
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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

hirify.global 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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