2 дня назад
Vigilance Specialist (M/F/X)
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
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.
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