Senior Pharmacovigilance Associate Analytics and Reporting
Vue: 197
Jour de mise à jour: 20-03-2024
Localisation: La Tour-de-Peilz Vaud VD
Catégorie: Btp Ventes Arts / Design Informatique Direction
Industrie: Pharmaceutique et biotechnologie
Type d’emploi: Temps plein, Temps de travail : 90-100%
le contenu du travail
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day. We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.
Job Description
As the Senior PV Associate Analytics & Reporting, within the Corporate PV Department, you will manage regular safety monitoring activities and compilation of periodic aggregate safety reports as part of our post-market surveillance activities. You will also be responsible for maintaining product Risk Management documentation and preparing different safety-related reports for regulatory submissions. You will be part of cross-functional teams within the company to provide PV support as assigned.
Your main tasks:
- Ensures regular and ad hoc safety data trending, signal detection and validation activities
- Contributes to the regular post-market surveillance review meetings. Coordinates and compiles the post-market surveillance plans and periodic safety update reports (PSURs) and other aggregate safety reports
- Contributes to relevant documentation for regulatory submissions for product registration, design changes and renewals, etc.
- Maintains and coordinates compilation of product Risk Management documentation
- Contributes to safety sections in the product Clinical Evaluation reports and Post-Market Clinical Follow-up reports
- Prepares responses to Competent Authorities or Notified Body for questions related to product safety
- Updates safety sections of product labelling, including the Instructions for Use or other reference safety information and patient brochures
- Supports study design discussions and compilation of safety sections of protocols, study reports, investigator brochures, development safety update reports (DSURs) and other applicable documentation for studies
- Participates in the writing/review of the department quality documents and the training of internal and external functions
Your profile:
- University Degree in Pharmacy or Life Sciences, ideally PhD
- Fluency in English
- Minimum 8 years of experience within pharmacovigilance/medical devices vigilance in the pharmaceutical/medical devices industry
- Solid knowledge of risk management and signal detection standards and methodology
- Expertise in the medical device/pharmaceutical regulations in Europe and US
- Analytical skills with a capacity to interpret and compile large amounts of data and to read and understand regulations
- Excellent organization skills and the ability to plan work so that it is efficient and effective
- Independency and ability to take decisions to deliver results
- Experience in collaborating with cross-functional teams in an international setting
- Flexibility and ability to adapt in a fast-changing business environment
- Positive and open-minded attitude
Date limite: 04-05-2024
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