Nektar has an exciting opportunity for a Sr. Drug Safety Science Manager to join their Drug Safety team.
The Sr. Drug Safety Science Manager supports the medical component of Drug Safety activities, including surveillance activities providing scientific/clinical Pharmacovigilance expertise with a focus on the identification, evaluation and management of safety risks for Nektar products. Collaborates closely with the safety science directors and cross-functional partners to evaluate and actively manage risks in accordance with global regulatory frameworks. This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.
Essential Duties and Responsibilities:
- Works on complex issues where analysis of situations or data requires an evaluation of intangibles. Exercises independent judgment in methods, techniques and evaluation criteria for obtaining results. Creates formal networks involving coordination among groups. May act as lead.
- Organizes and performs independently or collaboratively as necessary, the relevant safety data analysis for Safety Review meetings.
- Ensures adequate documentation of meeting minutes.
- Creates and maintains an effective signal tracking process that fully documents signal evaluation activities and can be used for regulatory inspections.
- Supports other function teams for Nektar investigational products
- Serves as Drug Safety Science expert and liaise with Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research Management and other entities as needed
- Contributes to health authority and other safety related query responses
- Reviews the informed consent form templates to ensure alignment with protocol and the Investigator Brochures
- Supports study teams for Nektar investigational products
- Serves as Drug Safety Science expert and liaise with Clinical Operations, Medical Affairs
- Demonstrates knowledge and ensures compliance with current and applicable global Pharmacovigilance regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.)
- Ensures compliance with Nektar and Pharmacovigilance & Risk Management policies and procedures
- Prepares aggregate safety reports (e.g. DSURs, PSURs, RMP), including project management, safety database requests, understanding and writing the content, assimilating information from other groups, and perform quality checks
- Plans and executes literature surveillance
- Contributes to the preparation of CSR and BLA filings
- Provides leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high quality safety reports
- Supports Drug Safety activities as requested
Bachelor's degree required; equivalent experience may be accepted. PharmD, PhD, MPH, or Master of Nursing advance healthcare degree preferred. Minimum 10 years’ pharmacovigilance or relevant experience, including at least 2 years’ concentration on aggregate safety report writing required. Thorough understanding of the drug development process and context applicable to safety surveillance activities. Knowledge of MedDRA terminology and its application. Excellent written and oral communication skills. Strong attention to detail, and high-performance standards for quality. Ability to analyze, interpret, and summarize complex clinical and medical literature data. Ability to prioritize and complete work in a resourceful, self-sufficient manner while maintaining a strong mentality. Displays ability to understand established procedures and communicate those procedures to others. Exhibits comprehension of industry practices and regulations for drug development and pharmacovigilance. Demonstrates awareness of related medical disciplines and an understanding of general concepts and some experiential detail within those areas. Possesses computer skills to support use of electronic systems and development of writing deliverables.