Website Alsinova
What we will accomplish together:
Alsinova, the CRO subsidiary of the Astek Group, is looking for a Pharmacovigilance (PV) Specialist – Post-Market to support one of our pharmaceutical partners in ensuring patient safety and regulatory compliance in the post-authorization phase of medicinal products.
Your mission (should you decide to accept it):
As part of the Drug Safety Department and under the supervision of the PV Manager, your mission will be to ensure that all pharmacovigilance activities related to marketed products are conducted in full compliance with regulatory requirements and internal procedures.
You will serve as a key contact for internal stakeholders and health authorities on post-market safety matters, helping ensure timely and accurate communication of safety information.
Your daily activities will be:
- Processing and evaluating Individual Case Safety Reports (ICSRs) from spontaneous, literature, and solicited sources
- Drafting and reviewing medical evaluations and narratives for serious and non-serious cases
- Assisting in signal detection and risk assessment, and supporting related decision-making
- Contributing to the writing and maintenance of Risk Management Plans (RMPs) and Periodic Safety Reports (PSURs, PBRERs, DSURs)
- Participating in audits and inspections, and implementing CAPAs as needed
- Ensuring regulatory compliance (GVP, EMA, FDA, ICH) and keeping procedures up to date
- Managing data entry and quality control in safety databases (e.g., Argus, ARISg, Veeva Vault Safety)
- Supporting communication with regulatory authorities and health professionals
- Collaborating with internal cross-functional teams (RA, QA, Clinical, Medical Affairs) and global safety teams
Your future team:
Join a collaborative and agile CRO environment where innovation, regulatory excellence, and scientific integrity drive every decision. You’ll be supported by experienced colleagues, in a human-sized organization backed by the global reach of the Astek Group.
- Strong organizational skills, attention to detail, and ability to work autonomously
You:
PharmD or Master’s degree (Bac+5) in Pharmacovigilance, Pharmacy, or Life Sciences.
- Minimum 3 years’ experience in post-marketing pharmacovigilance
- Excellent knowledge of GVP guidelines and EU pharmacovigilance regulations
- Hands-on experience in :
- ICSR case processing
- Narrative writing and medical review
- Signal detection and benefit-risk evaluation
- Authoring safety reports (PSURs, PBRERs)
- Familiar with PV databases and safety systems (e.g., Argus, ARISg, Veeva Vault Safety)
- Experience with inspections or audits is a plus
- Fluent English and French, both spoken and written
We base our relationships on:
- Respect for employees and clients, and their aspirations,
- Personalized support for employees and clients,
- Regular career management,
- Transparent communication,
- Constant responsiveness, availability, and attentiveness.
- Strong organizational skills, attention to detail, and ability to work autonomously
Alsinova
Alsinova is setting new standards for CROs by integrating multidisciplinary expertise with advanced technology. Alsinova offers a complete CRO solution, providing innovative, customised solutions in various life science segments: pharmaceuticals, biotechnology, medical devices, cosmetics, agri-food, veterinary and healthcare institutions.
Alsinova is the subsidiary of the Astek Group, a global player in engineering and technology consulting. Since its creation, the Group has based its development on a strong culture of entrepreneurship and innovation, and on the support and skills development of its 10.000 employees who are committed every day to promoting combination of digital technologies and complex systems engineering.
Join a Group rapidly developing in France and around the world, with a turnover of 705 M€ in 2024.
More on the Group on our websites https://alsinova.com and https://astek.net.
Astek is committed to the employment of people with disabilities.
Our benefits
Joining Astek means choosing:
- an experience accelerator, where every assignment is an opportunity to progress
- access to a multitude of technically exciting projects for our clients as well as internally
- individualized, local support for a tailored career path
- continuous learning, thanks to our internal training academy
- a friendly and inclusive work environment, supported by #TopEmployer2025 certified HR practices
Let’s move forward.
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