Job description
Amaris Consulting is looking for a Vigilance Specialist / Pharmacovigilance Specialist (M/F/X)to join one of our clients in the pharmaceutical industry.
Your responsibilities
- Manage pharmacovigilance and, where applicable, medical device vigilance cases.
- Receive, record and follow up on Adverse Events (AEs).
- Assess the seriousness, expectedness and causality of individual cases.
- Code adverse events using the MedDRA dictionary.
- Ensure complete and accurate documentation of cases in accordance with established procedures.
- Contribute to safety signal detection and assessment of the relationship between the event and the medicinal product.
- Contribute to the preparation of PSUR/PBRER and DSUR reports, depending on the scope of activities.
- Ensure compliance with regulatory reporting timelines and applicable requirements.
- Work closely with Quality, Regulatory Affairs, Clinical and Medical teams to ensure consistency and compliance across vigilance activities.
- Contribute to the continuous improvement of vigilance processes and procedures.
About you
- Degree in Pharmacy, Life Sciences, Health Sciences or a related scientific field.
- Previous experience in pharmacovigilance, vigilance or drug safety.
- Good 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.
- Strong analytical and organizational skills, with the ability to manage multiple cases simultaneously.
- Excellent attention to detail and strong written communication skills.
- Fluent in French and English, both written and spoken.
What we offer
- An international community bringing together 110+ different nationalities
- An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibility
- A robust training system with our internal Academy and 250+ available modules
- A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
- At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support.
- Benefits: access to our gym club, lunch vouchers and free Spanish classes
- Remote policy: Possibility to work remotely 2 days per week
Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
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