About the role

Pharmacovigilance associate managing serious adverse events and patient safety for Veristat’s clinical research programs. Supporting safety reporting, training, databases, sponsors, and investigator sites.

Responsibilities

Process and manage serious adverse events
Oversee study patients’ safety matters
Work closely with other departments, sponsors, and investigator sites
Ensure proper plans are in place to appropriately collect and report Adverse Events (AEs) and Serious Adverse Events (SAEs)
Facilitate the development and implementation of training programs for internal and external personnel managing safety information
Assist the department head in managing relevant safety group activities

Bachelor’s Degree in a science or related field required
2-4 years of pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment required
Proficient with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines
Knowledge of medical terminology, clinical trials, and clinical research
Excellent project management, written and oral communication, organizational, and interpersonal skills
Familiarity with and ability to effectively utilize safety databases
Proficiency in English (written and verbal) required
Ability to build and lead effective project teams, motivate others, delegate, and make and implement decisions
Ability to build and maintain trust and confidence and communicate effectively with clients, external vendors, and internal team members
Ability to mentor and delegate