Temporary 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. Our industry-leading drug discovery platform, which includes comprehensive proprietary libraries of the extracellular proteome and differentiated screening capabilities, has led to a pipeline comprising five development programs in clinical trials across multiple indications in 2019. We also have several undisclosed research programs that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process using our proprietary screens to discover new immuno-oncology targets.
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. 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.
Applies judgment and professional knowledge. Performs the following technical duties:
- Conducts quality review of cases processed by CROs to ensure completeness, correctness and consistency within department, corporate partners and regulatory timelines.
- Completes 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.
- Monitors the receipt of initial and follow up SAE reports and performs data entry into the SAE safety tracker
- Submits 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
- Acts as a liaison with internal and external business partners on Safety operation management issues.
- Prepares metric reports pertaining to Drug Safety department for management.
- Participates in the creation and compliance of FP policies and department standard operating procedures.
- Gathers safety information for internal use, and safety review
- Represents Drug Safety Department in study team meetings.
- Contributes to inspection readiness planning, as needed.
- Supports the training of new personnel on reporting of adverse events
- Ensures filing of SAE reports, SUSARS, and safety documents.
- Facilitate 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.
- Supports 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.
This job requires a combination of initiative, analytical, organizational and interpersonal skills. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- A Bachelor’s degree in a healthcare or scientific discipline; RN, BSc.3 -4 years of experience in safety management and safety reporting at a CRO or pharma company
- Minimum of 4-5-years previous Pharmacovigilance experience in case processing
- 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.
Five Prime acknowledges that providers may be a valuable resource for identifying and recruiting candidates for employment. However, we require that all recruiters engage directly with Five Prime’s Talent Acquisition Team and comply with Five Prime’s requirements prior to transmitting any resumes/CVs or introducing any candidates to Five Prime. Five Prime’s Talent Acquisition Team is the only function within the Company that can enter into contractual relationships with external recruiters and recruiting agencies. As such, all unsolicited resumes, CVs, anonymous profiles, or candidate information you may submit to employees of Five Prime will become property of Five Prime and Five Prime will have no obligation to pay you or anyone else for the use of such information, including any finder’s, placement, introduction or placement fee.