Senior Associate, Pharmacovigilance - Remote

1w1 week ago

Worldwide Clinical Trials

RS · Full-time · €45,000 – €70,000

About this role

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure is built by pioneering approaches implemented with quality and excellence. We are Worldwide Clinical Trials, a team of over 3,500 experts changing how the world experiences CROs. Our mission is to work with passion and purpose every day to improve lives.

Pharmacovigilance is the gateway to ensuring drug safety. Our dynamic team with extensive Drug Safety experience reviews safety events from around the world. We work with clients to analyze and submit to Investigators, Ethics Committees, IRBs, and Regulatory Agencies, advancing clinical drug development.

Everyone plays an important role in making a world of difference for patients and caregivers. From hands-on leaders to cohesive teams, we enable professionals from all backgrounds to succeed in a diverse, inclusive environment. We promote collaboration and creativity where people thrive by being themselves.

Join a group watching drugs progress from First in Human Administration to global regulatory approval. Participate in the entire lifecycle of compounds reaching the market. Be inspired to do your best work every day furthering drug safety and development.

Requirements

Excellent understanding of medical and scientific terminology
Excellent understanding of principles of clinical assessment of adverse drug events
Excellent understanding of international regulations and reporting requirements
Excellent understanding of computer technology and management of relational database systems
Proficiency in extraction of data from safety databases
Experience reviewing SAE data for completeness and accuracy
Knowledge of pharmacovigilance processes including query generation and resolution

Responsibilities

Author Safety Management Plan for assigned studies
Attend internal and client meetings as appropriate and present at Investigator Meetings
Review incoming SAE data for completeness and accuracy
Perform data entry in the Safety Database and track incoming safety information
Generate queries for missing or unclear information and follow up with sites for resolution
Perform QC of SAEs processed by other PV Associates
Generate regulatory reports and perform safety submissions as needed
Prepare and submit periodic safety reports as needed