Drug Safety Specialist II

Location
San Francisco, CA, United States
Posted
Jun 27, 2018
Ref
2-3316-340-2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Summary:

Ensures compliance with standard operating procedures, Food and Drug Administration and ICH guidelines and regulations, and global regulations for the reporting of adverse events to regulatory agencies. Develops guidelines and insures the uniform and timely processing of adverse event reports. Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements. Develops and prepares reports for company management as well as external regulatory agencies. Assists in the preparation of safety updates for investigational new drug and new drug applications, investigator communications, product labeling/package inserts and other reports as necessary. May work with data management in the ongoing development of case report forms for clinical trials and maintenance of databases. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Responsibilities:

Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Performing complete data entry of serious adverse events received from clinical trials, according to the Nektar workflow processes and standard operating procedures. Generate accurate and complete case narratives based on information received as part of source documents including but not limited to, case report forms, hospital admission notes, history and physical (H&P) consult notes, progress notes, lab results, results of diagnostic, radiological and other tests, discharge summaries, death certificate and autopsy results provided by the study sites. Draft appropriate queries for outstanding information or incomplete data and communicate the queries to study site personnel following review and approval of the queries by a senior Nektar Drug Safety person. Communicate or notify Nektar drug safety staff of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines. Maintain and track all serious adverse events reported from Nektar sponsored clinical trials for case processing relative to their priorities and submission deadlines. Support Drug Safety Department initiatives on ad hoc (as needed) basis. Adherence to global regulatory regulations and reporting timelines for all expedited serious adverse events. Maintain or track annual and/or periodic Pharmacovigilance regulatory submissions in USA and globally. Ensure compliance with Nektar's SOPs.

Requirements:

A Bachelors degree in a scientific discipline is required. RN or BSN degree is highly desired. Equivalent experience may be accepted. A minimum of four years experience in Drug safety or Pharmacovigilance, with at least two years hands-on experience in serious adverse event management in clinical trials evaluating investigational products is required. Experience in oncology therapeutic area is preferred but not mandatory. Familiarity with Medical terminology required. Ability to process data entry accurately. Ability to code and map data accurately. Concise case narrative (medical) writing experience preferred. Ability to prioritize work without much support. Clear effective written and verbal communication skills are essential for effective communication with study sites. Focused and detail oriented. Work effectively as a team member, promote collaboration. Self starter and self accountability. Relevant industry experience is highly preferred. High level of work conduct.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.