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.
#LI-MR2
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!