SAFETY SCIENTIST/PV OFFICER

TN France; Saclay; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

An established industry player is seeking a skilled Safety Scientist/PV Officer to join their team. This pivotal role involves supporting pharmacovigilance activities, coordinating signal detection, and preparing essential safety reports. With a focus on maintaining the highest safety standards, you will work closely with project managers and medical safety leaders to ensure comprehensive safety evaluations. If you have a strong background in pharmacy and a passion for safety in the healthcare sector, this opportunity offers a chance to make a significant impact in a dynamic environment.

Qualifications

• 10+ years of experience in safety within the pharmaceutical industry.
• Strong background in pharmacovigilance and safety data analysis.

Responsabilités

• Assist in coordinating signal detection activities and safety data analysis.
• Support the generation of aggregated safety reports for marketed compounds.

Connaissances

Pharmacovigilance

Safety Data Analysis

Signal Detection

Report Writing

Formation

Pharmacy Degree

Description du poste

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KELLY, an intellectual services company dedicated to the healthcare industry, supports its customers throughout the drug development and evaluation process. We are recruiting a SAFETY SCIENTIST/PV OFFICER M/F for one of our clients, a major pharmaceutical laboratory based in the IDF region.

Your main missions will be:

1. Assist Pharmacovigilance Project Managers/Medical Safety Leaders in coordinating signal detection activities, including kick-off activities, planning, safety data retrieval and analysis, authoring sections of Safety Evaluation Reports (SER) or Development Safety Evaluation Reports (DSER), creating or updating appendices, and Quality Control (QC) for development and marketed compounds.
2. Support the generation of aggregated safety reports for both development and marketed compounds (PBRER, PSUR, PADER, DSUR, INDAR, 6-monthly line listings), including setting up kick-off activities, planning, safety data retrieval and analysis, authoring sections, creating or updating appendices, producing tables and figures, and QC.
3. Prepare product datasheets related to CCDS/CCSI/RSI/IB or local PI, and oversee the review and approval process. Support maintenance of safety sections of the CCDS (CCSI).
4. Perform other related tasks as required.

Your profile:

• Pharmacist with at least 10 years of experience in safety.