Individual Case Safety Reports (ICSR) Manager, Global Patient Safety
About this opportunity
Title:
Individual Case Safety Reports (ICSR) Manager, Global Patient Safety
Company:
Ipsen Pharma (SAS)
About Ipsen:
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!
For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram .
Job Description:
Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company?
Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.
Why Ipsen?
Patient-Focused: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.
Employee Care: We care for our employees, who are the ambassadors making a real difference.
Bold Leadership: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.
Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.
About the Role:
Within the Global Patient Safety (GPS) department, the ICSR Manager is a key contributor in the Individual Case Safety Reports (ICSRs) management.
You will :
Manage all ICSRs topics with respect of the regulatory guidelines and Ipsen standards in ensuring ICSRs readiness for quality and distribution under the regulatory and internal timelines.
Work in close collaboration with the external vendor who is responsible of ICSRs management in the Ipsen Global Safety Database.
Main Responsibilities
Quality control process:
Oversee all GPS quality controls on data entry of cases performed by ICSR vendor
Monitor the case quality indicators as defined in Ipsen standards and deliver the results
Perform weekly quality control of approved cases handled by ICSR vendor
Work in close collaboration with GPS Therapeutic Area team to establish a robust TA case corrections process and ensure good communication with ICSR Vendor
Be responsible to maintain up-to-date and accurate the Data Handling conventions for the ICSR vendor
GPS ICSR Vendor management:
Participate in operational meetings with the ICSR vendor to maintain the quality and compliance on the level expected by Ipsen
Ensure regular training of ICSR Vendor to maintain the level needed with the data quality governance
Transversal activities:
Participate as Subject Matter Expert to the projects related to ICSRs activities
Participate in the writing and updating of the documents/procedures related to the activities
Participate in the training of GPS ICSR vendor on ICSR case management processes
Act for process improvement in close collaboration with all Ipsen stakeholders & external providers
Coordinate outsourced activities
Qualifications:
Master’s Degree in Natural Sciences
Strong experience within Drug Safety, Clinical Development and/or Pharmacovigilance
MUST HAVE strong experience in Quality Assurance and case management
Full breadth of knowledge of all phases of drug development
Advanced knowledge and understanding of Pharmacovigilance
Strong experience of delivering ICSRs
Expertise in safety data collection systems, safety reporting tools and safety databases,
Experience collaborating with external vendors
Experience with complying to internal SOPs and other requirements
Training on computer/software used in Pharmacovigilance & literature screening
Knowledge of Safety evaluation, MedDRA, PV regulations
Proficient user of modern IT and Office software
Fluent in English
#LI-HYBRID
Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us*». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même
Job details
How this role compares
Computed from every other active Pharmacovigilance role in our database, not just this employer's listings.
We currently track 32 comparable Manager Pharmacovigilance roles across 20 biopharma companies.
Salary context
4 of 32 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 32 comparable roles
+ 9 more countries
Seniority mix
32 of 32 peers have a known seniority level
Therapeutic area mix
0 of 32 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.