Senior Pharmacovigilance Associate Analytics and Reporting

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