Senior Drug Safety Associate
Role and Responsibilities
- Ensures compliance with standard operating procedures, regulatory safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA), World Health Organization, country and regional regulations for the reporting of adverse events to regulatory agencies
- Develops and implements pharmacovigilance guidelines and ensures the uniform and timely processing of adverse event data on all marketed products in development
- Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
- Develops and prepares reports for company management as well as external regulatory agencies
- May provide medical evaluation of adverse event reports
- Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports as necessary
- May work with data management in the ongoing development and maintenance of databases
- Possesses wide-ranging experience in the area of Drug Safety and Pharmacovigilance and uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
- Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
- Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results
- Determines methods and procedures on new assignments
- May coordinate activities of other personnel (team lead)
- Expertise with Review of the MedDRA and Who drug coding
- Review/contribute to Aggregate report writing as necessary.
- Other tasks as requested by the management.
Qualifications and Education Requirements
- Bachelor’s degree in or equivalent experience
- Medical background.
- 8+ years of related experience required
- Excellent teamwork and collaboration skills
- Proficient with Microsoft Office.
- Able to build effective working relationships throughout the organization internally and externally to achieve goals.
- Flexibility and willingness to solve problems that fall outside of immediate area of expertise
- Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
- Work independently in an interdisciplinary, fast-paced, often changing environment.
- Committed to the values of integrity, accountability, adaptability, and drive.
*Local Bay Area Candidates Only*
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