Introduction
At our client, over 75,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, they have become one of the world's leading research-focused healthcare groups. Success is built on innovation, curiosity and diversity, and on seeing differences as an advantage. Drug Safety Science has become increasingly important in a very dynamic environment and plays a key role in adding value at each stage of the products' lifecycle and supporting key decisions at this company.
Summary of duties
The Safety Scientist is responsible for carrying out pharmacovigilance activities on a product or group of products, including single case processing, aggregate reporting, signal detection and evaluation of PV database.
Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues
Support the preparation and maintenance of Risk Management plans for the submission to Regulatory Authorities
Prepare and review periodic safety reports (PSUR, EU Annual Safety Reports) in accordance with regulatory requirements and Drug Safety standard operating procedures
Support the preparation and maintenance of safety sections of the Company Core Data SheetLead/support Drug Safety post-marketing safety study activities
Coordinate safety activities between Drug Safety and internal and external partners
Qualifications required
Prior experience in safety is desirable
Ph D or MD candidates with solid pharmaceutical experience in clinical development or medical affairs
Industry experience in drug safety or clinical development
Good knowledge of pharmacovigilance practices
Abilityto evaluate, interpret and synthesize scientific data (analytical thinking)