Sr. Manager/Associate Director, Drug Safety
Department/Group: Clinical Development
Location: Burlingame, CA
Position Type: Full time
Role and Responsibilities
- Manages and oversees the company’s drug safety and pharmacovigilance process
- Manages compliance with standard operating procedures, regulatory safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA) and World Health Organization, global, regional and country regulations for the reporting of adverse events to regulatory agencies
- Develops and prepares reports for company management as well as external regulatory agencies
- Participates in review and assembly of the data for the quarterly safety data review committee meetings.
- Familiar with MedDRA and Who-drug coding review.
- Familiarity with Pharmacovigilance and drug development, including knowledge of applicable international clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.
- Interfaces with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements
- Oversees the development and preparation of reports for company management as well as external regulatory agencies
- Manages and conducts ongoing safety surveillance on company products
- Contributes to review and writing of the assigned protocols, IBs, and DSURs for specific products as requested by the management.
- Participates in oversight of ongoing clinical trials and in the preparation of new drug applications with respect to drug safety
- Involved in developing, modifying and executing company and departmental policies that affect immediate operations and may also have a company-wide effect
- Ensures that budgets and schedules meet corporate timelines
- Must have strong negotiation skills with vendors and management in order to influence senior leaders regarding safety matters of significance to the organization
Qualifications and Education Requirements
Bachelor’s degree or equivalent experience required
5-7 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, transparency, and drive.
Join our Team
Local Bay Area candidates only please! If you are interested, please submit a cover letter and your resume to firstname.lastname@example.org