Director/AD Drug Safety (AdvancedGroup_411561) San Francisco, California
Job Number: 411561
Director/AD Drug Safety
The Director/Associate Director, Drug Safety is a position whose primary focus is to manage adverse event reports in relation to our products, from both clinical and post-marketing setting. This position works with internal Medical Director(s) and other members of Clinical Development and Regulatory Affairs to ensure acquisition of appropriate information, assessment of the adverse events, and timely reporting of serious adverse events (SAEs) including expedited and annual reporting. This position presents information to the quarterly Medical Safety Review Committee (MSRC), interacts with corporate partners on safety issues, and provides advice and consultation to Clinical Operations and Data Management regarding safety reports. The Director/Associate Director, Drug Safety, works closely with the Medical Director(s) for each product area for guidance on interpretation of adverse event reports and on the safety aspects of protocol design.
?Performs the triage for adverse events to determine regulatory reporting requirements.
?Contacts investigators or coordinators and other consumers of our client’s products to solicit comprehensive information about reported adverse events as well as relevant follow-up information.
?Enters cases into the internal safety database system.
?Writes case summaries and performs analysis of similar events.
?Reviews published literature of clinical and preclinical reports to provide the context for all reported serious adverse events.
?Prepares IND safety reports for medical review and for filing by Regulatory Affairs with the FDA and other agencies as appropriate.
?Participates in reconciliation between clinical trial and safety databases.
?Periodic review of all safety information for specific products and presentation of this information at quarterly MSRC meetings and team and corporate meetings as requested.
?Communicates and exchanges information with corporate partners regarding safety issues for our client’s products.
?Coordinates and oversees the notification of investigators and IRBs of IND safety reports.
?Summarizes all necessary safety information in preparation of periodic safety reports.
?Maintains safety SOPs and assures that the appropriate personnel are trained accordingly.
?Responsible for safety related education programs for internal and site personnel.
?Writes the safety sections of clinical protocols and case report forms (CRFs).
?Provides guidance on MedDRA coding.
?Define and assess requirements for drug safety adverse event database.
?Will have supervisory responsibilities.
?Comply with our client’s Policies and Procedures.
?8-12 years relevant experience within the pharmaceutical industry in managing safety and/or post-marketing surveillance.
?Understanding of Safety Systems (ARGUS, AERS, etc.)
?Knowledge of Good Clinical Practices adverse event reporting guidelines.
?Knowledge of FDA regulations for investigational and marketed pharmaceutical products or biologics
?Excellent written and verbal communication skills, organizational skills, and attention to details.
?Self-motivated, assertive and able to function both independently and as a team member.
?Computer experience with MS Word, Excel, MS Access, and Email as a minimum.
?PharmD, RN, MSN or equivalent is preferred.
?Knowledge of worldwide safety requirements a plus.
Interested candidates please send resume in Word format to email@example.com Please reference job code 411561 when responding to this ad.