Drug Safety Manager

Location
Burlingame, California
Salary
competitive
Posted
Jul 23, 2018
Required Education
Bachelors Degree
Position Type
Full time

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

Preferred Skills

  • 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:  careers@corvuspharma.com