Sr. Manager, Drug Safety (PV Quality and Compliance)

Location
San Francisco, CA, United States
Posted
Oct 12, 2020
Ref
5227-512-NB
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Sr. Manager, Drug Safety to join their team.

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.

Works on complex problems in which analysis of situations or data requires in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Assists in developing and implementing the pharmacovigilance monitoring framework. Participates in or leads the generation and review of quality and compliance metrics, vendor key performance indicators, and safety management plans. Promptly escalates non-compliance events and assists with root cause analysis, investigations, and implementation of corrective and preventive action (CAPA) measures. Serves as the department training coordinator. Performs ICSRs quality checks and other case management functions. Functions as drug safety operations study lead where needed. Performs vendor oversight. Participates in procedural documents drafting. Supports Drug Safety Department initiatives on ad hoc (as needed) basis. Adheres to global regulatory regulations and reporting timelines for all expeditedsafety reports. Ensures compliance with Nektar's SOPs.

A Bachelors degree in a scientific discipline is required. An advanced degree such as a, PharmD, RN or BSN is preferred. Equivalent experience may be accepted. A minimum of 10 years experience in drug safety / pharmacovigilance, with at least 6 year's hands-on experience in adverse event management in clinical trials evaluating investigational products is required. A minimum of 5 years previous management experience may be required. Experience in pharmacovigilance quality and compliance monitoring. 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.