Pharmacyclics, LLC

Safety Scientist, Safety Surveillance and Risk Management

Location
Sunnyvale, CA, United States
Posted
Nov 12, 2018
Ref
2541
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

To learn more about us, please visit us at http://www.pharmacyclics.com/

General Position Summary/Purpose:

The Drug Safety Scientist assists and supports the ongoing aggregate review and analysis of product safety for both pre and post-marketing data. Tasks include preparation and authoring of aggregate safety data including signaling analysis, DSUR, PSURs (Periodic Safety Update Reports), Annual Safety Reports, and reports to support internal/external data safety monitoring boards. The Drug Safety Scientist will collate relevant clinical safety information for safety signal review as guided by the director or manager.The Scientist will also support other applicable Pharmacovigilance Plans, EU Risk Management Plans, product recalls, and other safety surveillance activities. The Scientist will author and assist in signal evaluations and the management of responses to regulatory agencies related to the assigned product and support query of safety data under the guidance of manager / director.

Key Accountabilities/Core Job Responsibilities:

  • Support safety surveillance for Pharmacyclics sponsored trials, programs, and post marketing activities which include:
    • Use of medical background and experience to integrate case-related information including medical conditions, lab results and procedures and effectively identify risk factors
    • Ability to gather, extract, synthesize and present both clinical and postmarketing aggregate safety data for signal detection review and evaluation.
    • Performing and/or actively participating in signal detection meetings (including presentation of data) on a scheduled basis
    • Tracking events of special interest
    • Performing literature searches and evaluation
    • Participating in internal pharmacovigilance committee meetings and joint safety meetings with licensing partners (activities include, but are not limited to, presentation of safety data and taking meeting minutes)
    • Assisting in preparation of safety related sections and associated documentation for clinical and regulatory documents (including clinical study protocols, patient informed consent forms, clinical study final reports, IND annual reports, DSUR, PSUR, integrated summaries of safety, RMP and European clinical expert reports)
    • Assisting in the creation/revision of department procedures and policies


Education, Experience and Qualifications:

  • At a minimum, Bachelor's level degree in life sciences, pharmacy or nursing with 3-years of Drug Safety/Pharmacovigilance experience OR an advanced degree medical degree (MD, PharmD, PhD, RN) in lieu of Drug Safety Experience.
  • Strong organizational, teamwork, and interpersonal skills and professionalism required.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
  • Outstanding communication skills (verbal and written).
  • Focus on detail with enthusiasm to constantly seek ways to improve processes and practices.
  • Ability to manage multiple projects in a fast-paced environment.
  • Collaborate effectively with the study team, cross-functional team members, and external partners.
  • Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environment as well as postmarketing environment preferred
  • Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding preferred.
  • Proficient with Windows: MS Word, Excel, Power Point; and ability to learn new programs as needed.
  • Familiarity with common Safety databases (e.g., Arisg, AERS, Argus, etc.) preferred.


Equal Opportunity Employer Minorities/Women/Veterans/Disabled