Senior Associate, Pharmacovigilance - Japan

This is a fully remote position, open to applicants in Japan.

📋 Description

• Develop Safety Management Plans for designated studies

• Participate in internal and client meetings as required

• Attend and deliver presentations at Investigator Meetings

• Evaluate incoming Serious Adverse Event (SAE) data for thoroughness and accuracy

• Conduct data entry in the Safety Database and monitor incoming safety data

• Create queries for any missing or ambiguous information and follow up with sites for clarification

• Perform quality control checks on SAEs handled by other Pharmacovigilance Associates

• Prepare regulatory reports and handle safety submissions as necessary

• Compile and submit periodic safety reports as required

• Stay informed about safety-related regulations and guidelines

• Maintain a fundamental understanding of project budgets and scopes of work, ensuring adherence and raising potential scope alterations

• Support bid defenses or other presentations as necessary

• Mentor or provide training to new Pharmacovigilance staff as needed

• Carry out additional duties as assigned

⛳️ Requirements

• Bachelor’s degree in a science-related field, nursing, or an equivalent qualification

• At least 5 years of pharmacovigilance experience in pre-approval clinical trials

• A suitable combination of relevant education and experience

• Proficient in computer skills and a strong working knowledge of MS Office applications (Excel, PowerPoint, Word)

• Strong understanding of medical and scientific terminology

• Familiarity with clinical assessment principles pertaining to adverse drug events

• Knowledge of international regulations and reporting obligations

• Understanding of relational database systems, including data extraction techniques

• Exceptional written and verbal communication abilities

• Capability to work autonomously, effectively prioritize tasks, and thrive in a matrix team environment

• Willingness to undertake limited domestic and international travel as required

• Proficient in written and spoken English

🏝️ Benefits

• A diverse and inclusive workplace environment

• A collaborative and creativity-driven culture

• Opportunities for limited domestic and international travel