Director, Drug Safety Operations

San Francisco, CA, United States
Aug 23, 2019
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

The Director, Drug Safety Operations will develop and review pharmacovigilance policies and processes to comply with regulatory rules and guidance.

Ensures high quality safety data entry and reporting. Directs and contributes to the preparation of DSURs, PBRERs, Product Labeling and other cumulative safety reports as necessary. Directs and contributes to safety reports, summaries and license applications for regulators, external partners and company management. Participates in oversight of clinical trials and postmarketing surveillance. May help select, develop and evaluate personnel to ensure the efficient operation of the function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Works on complex issues where analysis of situations or procedures requires an in-depth knowledge of the company's drug development operation. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures budgets and schedules meet corporate requirements. Designs, implements and reviews drug safety processes and policies to ensure compliance and inspection worthiness. Identifies gaps and inefficiencies and proposes solutions. Provides expert guidance and strategic planning for the operation of drug safety to support clinical development and product marketing. Ensures appropriate regulatory authority reporting, dissemination of safety information and provides pharmacovigilance guidance to development project teams. Development of Core Safety Information and editing of safety information for inclusion in clinical trial documents and applications. Provides Clinical Safety services including review of AE coding and SAE collection, assessment and reporting. Develop, track and review safety data/pharmacovigilance agreements with partners, licensees and independent investigators. Establishes, implements and maintains performance metrics. May direct other quality staff and/or functions. May be responsible for providing regular performance feedback, development and coaching to direct reports. Other duties as required.

A minimum of a Bachelors degree in life sciences is required. An advanced degree such as a, PharmD, PhD or MD is preferred. Equivalent experience may be accepted. A minimum of 13 years experience in the pharmaceutical or other related industry with a minimum of 8 years drug safety experience is required. A minimum of 10 years previous management experience may be required. Thorough understanding of FDA and European regulations, GVP and ICH guidelines. Knowledge of Drug Safety regulations, experience with safety databases and industry dictionaries is required. Must have a strong working knowledge of safety components of cinical trial documents and reports. Strong oral and written communication skills are required. Experience working in a multidisciplinary team is required. Good computer skills are required. Must be detail and strategy oriented. Must demonstrate decision-making, initiative and analytical skills.

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.