Drug Safety Associate
- 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to improve the lives of patients with serious diseases. We have an industry-leading and differentiated drug discovery platform. Our comprehensive proprietary libraries of the extracellular proteome, differentiated screening capabilities and protein therapeutic generation and engineering capabilities comprise a unique and powerful IND engine that will continue to generate important development programs. This uniquely positions us to discover novel pathways and targets in immuno-oncology. Our success with our drug discovery platform has led to a pipeline that is on track to more than double to five development programs in clinical trials across multiple indications in 2018. We also have several undisclosed research programs at different points of the target validation and molecule generation phases that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process at the earliest stages with new screens planned this year.
Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. We value our culture of openness, collaboration and productivity. The company is in a strong financial position and has an effective executive team and Board of Directors. Discover more about FivePrime at www.fiveprime.com.
The Drug Safety Associate works in a team-oriented environment supporting the drug safety staff in the day today operational job responsibilities. This includes but not limited to the collection, review, and processing of adverse event (AE) information received by CROs, Corporate partners and any other source in compliance with applicable FDA and global regulations, Five Prime (FP) Standard Operating Procedures (SOPs), and guidelines.
This role requires sound judgment and professional knowledge. Responsibilities include and are not limited to the following technical duties:
- Conducting quality review of cases processed by CROs to ensure completeness, correctness and consistency within department, corporate partners and regulatory timelines.
- Completing drug safety monitoring and tracking of Serious adverse reports for FP products in a timely manner in accordance with pharmacovigilance (PV), regulations, and FP Standard Operating Procedures.
- Monitoring the receipt of initial and follow up SAE reports and performs data entry into the SAE safety tracker
- Submitting completed CIOMS/MedWatch forms to regulatory affairs and CROs so that these can be submitted to regulatory authorities in time Maintains the regulatory submission tracker
- Liaison with internal and external business partners on Safety operation management issues.
- Preparing metric reports pertaining to Drug Safety department for management.
- Participating in the creation and compliance of FP policies and department standard operating procedures.
- Representing Drug Safety Department in study team meetings.
- Contributing to inspection readiness planning, as needed.
- Supporting the training of new personnel on reporting of adverse events
- Ensures filing of SAE reports, SUSARS, and safety documents.
- Facilitating the request for listings of similar events from the drug safety vendor, for the analysis of similar events as needed.
- Conducting periodic reconciliation of SAEs between drug safety and clinical trial databases for ongoing clinical studies with little or no supervision
- Participating in the preparation and submission of aggregate safety reports, such as Drug Safety reports to Ethics Committees and annual reports to regulatory authorities.
- Supporting the identification of new data management tools and innovative approaches
- Communicates and updates Team of any process related issues/ concerns Assists with special projects and other ongoing safety activities and programs as needed.
- Other duties as may be assigned.
- A Bachelor’s degree in a healthcare or scientific discipline; RN, BSc.
- Three plus years of experience in safety management and case processing/reporting.
- Experience in using drug safety database (ARISg or Argus)
- Experience in using MedDRA and WHO-Drug dictionaries
- Working knowledge of FDA and international pharmacovigilance and clinical safety regulations and guidelines
- Experience with exchanging safety data with business partners or affiliates
- Ability to manage timelines and maintain high quality of work and appropriately communicate items that could impact timelines or quality.
- Strong organizational skills, detail oriented, ability to adapt to change
- Proven team player with the ability to function in a multi-disciplinary environment
- Attention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions.
- Demonstrates initiative and accountability
- Ability to prioritize tasks in a timely manner
- Excellent written, oral communication, personal organizational skills and resourcefulness
- Ability to work well in cross-functional teams in a fast-paced challenging environment
- Proven proficiency using MS Word, Excel, Power Point and Outlook.
At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.
FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.Please call or reply with any comments.
All your information will be kept confidential according to EEO guidelines.