Pharmacovigilance and Patient Safety Associate

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Manage and process serious adverse events

• Supervise safety matters concerning study participants

• Collaborate closely with various departments, sponsors, and investigator sites

• Ensure adequate plans are established for the proper collection and reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs)

• Support the creation and execution of training programs for both internal and external personnel handling safety information

• Assist the department head in coordinating relevant safety group initiatives

⛳️ Requirements

• Bachelor’s Degree in a scientific or related discipline is mandatory

• 2-4 years of experience in pharmacovigilance and/or drug safety within a CRO, pharmaceutical company, or clinical trial setting is essential

• Strong understanding of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other relevant regulatory standards

• Familiarity with medical terminology, clinical trials, and clinical research

• Outstanding project management, written and verbal communication, organizational, and interpersonal abilities

• Experience with and capacity to effectively use safety databases

• Proficiency in English (both written and spoken) is required

• Capability to assemble and lead effective project teams, motivate others, delegate tasks, and make decisions

• Ability to cultivate and sustain trust and confidence while communicating effectively with clients, external vendors, and internal team members

• Skilled in mentoring and delegating responsibilities

🏝️ Benefits

• Remote working options

• Flexible time off policy

• Paid holidays

• Medical insurance coverage

• Tuition reimbursement program

• Retirement plans available

• Potential for applicable bonuses