Senior Pharmacovigilance Associate Analytics & Reporting Apply Now

Job Family

Pharmacovigilance

City

La Tour-de-Peilz

Region

Vaud

Country

Switzerland

Contract Type

 

Posting Start Date

09-Jul-2021

Company Overview

Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com    

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.

Job Responsibilities

• 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 (PBRERs, PSURs, ACOs) and other aggregate safety reports


• Contributes to relevant documentation for regulatory submissions for product registration, design changes and renewals, etc.


• Coordinates or contributes to the 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 labeling, including the Core Data Sheets, 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

Minimun Requirements

• MSc or PhD Degree in Pharmacy or Life Sciences


• Minimum 5 years of experience within pharmacovigilance in the pharmaceutical industry


• Solid knowledge of risk management and signal detection standards and methodology


• Expertise in the pharmaceutical regulations in Europe


• 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


• Fluency in English (written and spoken)

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