Drug Safety Manager
Role and Responsibilities
- The Drug Safety Manager manages and oversees the vendor activities for specified projects.
- Accountable for the processes and performance of all case processing activities, including procedures and tools for managing effective and compliant submissions for all investigational products.
- Develops and prepares reports for company management as well as external regulatory agencies
- Responsible for ensuring that all the study related start up, management and close out activities are consistent, cost-efficient and in compliance with regulatory requirements.
- Must demonstrate effective direct report management, leadership and collaboration skills with DSPV leadership and cross-functional partners. Demonstrate ability to manage a team of direct reports including mentoring and developing direct reports.
- Assist Corvus Data Management and Safety CRO with data query generation and resolution
- Participates in review and assembly of the safety data for the quarterly safety Data Review Committee meetings, DLT evaluation reviews, abstracts/presentations for scientific meetings, Board meeting presentations and other ad hoc analyses/presentations.
- Direct experience with MedDRA and Who-drug coding review.
- Contributes to review and writing of the assigned protocols, IBs, INDs and DSURs for specific products as requested by the management.
- Deep knowledge of Pharmacovigilance and drug development, including experience with applicable international clinical trial safety regulations and post-marketing safety regulations. Includes experience with case processing, expedited reporting rules, and safety database concepts.
Qualifications and Education Requirements
- Bachelor’s degree in science or healthcare related field and 3-5 years of experience in a pharmacovigilance role required
- Minimum of 3 years Case Processing experience (PV cases, ICSR, clinical trials, literature, post market etc.) and vendor management
- Experience with review of safety data for trends and MedDRA coding
- Experience with vendor agreements, post-marketing, clinical trial, literature search strategies, AE and study management,
- Strong knowledge and experience with Argus Safety system
- 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.
- Strong organizational, project management and leadership skills: Leads and conducts, independently and/or collaboratively.
- Work independently in an interdisciplinary, fast-paced, often changing environment.
- Committed to the values of integrity, accountability, transparency, and drive.
*Local Bay Area Candidates Only*
PLEASE SEND COVER LETTER AND CV TO: email@example.com