Назад
Company hidden
2 дня назад

Vigilance Specialist (M/F/X)

Формат работы
hybrid
Тип работы
fulltime
Английский
c1
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
/
TL;DR
Vigilance Specialist (M/F/X) (Pharmacovigilance): Managing pharmacovigilance and medical device vigilance cases, including adverse event follow-up, case assessment, MedDRA coding, and regulatory documentation with an accent on case quality, safety signal detection, and compliance with reporting timelines. Focus on assessing causality and expectedness, preparing PSUR/PBRER and DSUR reports, and improving vigilance processes across Quality, Regulatory Affairs, Clinical, and Medical teams.

Location: Hybrid; possibility to work remotely 2 days per week

Company

hirify.global is an independent technology consulting firm providing guidance and solutions across Information System & Digital, Telecom, Life Sciences, and Engineering.

What you will do

  • Manage pharmacovigilance and, where applicable, medical device vigilance cases.
  • Receive, record, and follow up on adverse events.
  • Assess case seriousness, expectedness, and causality, and code events using MedDRA.
  • Maintain complete and accurate case documentation in line with established procedures.
  • Contribute to safety signal detection and preparation of PSUR/PBRER and DSUR reports.
  • Coordinate with Quality, Regulatory Affairs, Clinical, and Medical teams while improving vigilance processes.

Requirements

  • Degree in Pharmacy, Life Sciences, Health Sciences, or a related scientific field.
  • Previous experience in pharmacovigilance, vigilance, or drug safety.
  • Knowledge of pharmacovigilance regulations and GVP requirements.
  • Good command of MedDRA coding.
  • Experience with a pharmacovigilance database such as Safety Easy, ARISg, Veeva Vault Safety, or EudraVigilance.
  • Fluent written and spoken French and English, with strong analytical, organizational, and communication skills.

Culture & Benefits

  • International community representing more than 110 nationalities.
  • Internal Academy with more than 250 training modules.
  • Regular internal events, including afterworks and team-building activities.
  • Access to a gym club, lunch vouchers, and free Spanish classes.
  • Remote work is available 2 days per week.
  • Opportunities to contribute to sustainability and social or environmental impact projects through the WeCare Together program.

Hiring process

  • Brief virtual or phone call.
  • Approximately three interviews, depending on seniority requirements.
  • Potential case study, technical assessment, role play, or problem-solving exercise.

Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →