Sr. Drug Safety Associate
Redwood City, CA
· Organize and distribute safety reports received from any contracted vendors or CROs for assigned products and/or studies, according to ICH-GCP guidelines, regulatory requirements and company SOPs, policies and procedures.
o Triages all incoming SAE reports, sasses for scheduling case reports due dates and expedite report status. o Verify product investigator brochure or reference safety information in performing initial case assessment for seriousness and expectedness;
o Responsible for initial evaluation and assessment of incoming case reports and source documentation for completeness, accuracy, legibility, and consistency of information, and performs necessary checks for duplicate cases; provided by vendors or CROs.
o Communicates with internal Kartos medical staff, their respective clinical research organizations (CROs) regarding the evaluation and processing of case reports;
o Perform coding review for all adverse event and SAE utilizing MedDRA and WHO-DD dictionaries, in accordance with coding policies and standards;
o Liaises with appropriate internal/external Medical Monitor to ensure that appropriate medical review and assessment is provided for assigned case reports;
o Determines necessary follow-up for missing, discrepant or additional information/source documentation for each case using medical, product and regulatory knowledge;
o Performs follow-up (telephone, e-mail or facsimile), as needed, or provide guidance to the CROs either directly with reporter or through appropriate CRAs, and documents results in case file;
o Ensures that required follow-up for assigned cases has been completed;
o Creates and maintains electronic and hard copy case files as per SOPs and guidelines;
o manage compliance of distribution of expedited reports to investigators and regulatory submissions
· Collaborates with appropriate Data Management personnel to ensure that key data fields are reconciled between the clinical and safety databases and assists in resolving discrepancies.
· Assists in the preparation of periodic and annual safety reports and investigator communications. · Generation of safety line listing reports, summary tabulations, and/or metric reports for company management, partner companies, and collaborative sponsors, as needed. Fluent in running reports from safety database (eg. CIOMS II line listing, summary tabulations, etc)
· Assists in the development of Patient Safety Narratives for final Clinical Study Reports, in conjunction with the appropriate Medical Writing and Data Management personnel, as needed
· Assists in the set-up of new safety projects, including development of study-specific Safety Management Plans, set-up of safety systems, training of internal and external project-team members in safety-reporting processes, and presentations at investigator meetings.
· Participates in Project Team and similar meetings, representing the Drug Safety department, as required.
· Supports the Clinical Operations teams with respect to safety-related issues, as required.
· Assists with the maintenance of the safety database, including participation in validation and implementation activities for system upgrades and maintenance of the safety database user manual.
· Assists in the development of departmental SOPs, policies and implementation guidelines.
· Assists in the training of appropriate Company personnel and external groups in pharmacovigilance and drug safety principles, policies, and SOPs
· Collaborates with pharmacovigilance and drug safety colleagues within global Partners.
· Contacts immediately the Director, Pharmacovigilance & Drug Safety if a regulatory agency has requested an inspection, or if there are any serious compliance observations within the Drug Safety department
· Performs other duties as requested by Management
Qualifications/Requirements: The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent
· At a minimum, Bachelor’ s level degree in life sciences, pharmacy, nursing or equivalent
· Previous safety, research or clinical experience in the pharmaceutical industry required. Minimum of 8yrs+ of Pharmacovigilance / Drug Safety experience, specifically in a global environment.
· Understanding of medical terminology and familiarity with principles of clinical assessment of adverse events in the pharmaceutical industry is highly desirable.
· Working knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial and post-marketing environments desirable.
· Working knowledge of MedDRA dictionary with relevance to adverse event coding.
· Experience in working with software-based drug safety systems a plus, preferably ARISg safety database.
· Ability to work independently, as well as within a team environment.
· Ability to work under supervision in a matrix organization.
· Excellent written and verbal communication skills
· Strong organizational and problem-solving abilities
· Strong interpersonal skills and professionalism required;
· Focus on detail with enthusiasm to constantly seek ways to improve processes and practice.
· Ability to work in a dynamic environment and manage competing priorities
· Oncology therapeutics experience preferred