Global PV Senior Scientist

ApTask Global Workforce (AGW) is seeking a Global PV Senior Scientist for a 12-month contract position with a Global Biotechnology Company located in Thousand Oaks, CA.

Summary:
The Global PV Senior Scientist works with the Therapeutic Safety Teams for safety assessment activities for medical and scientific operations. This role is responsible for directing the planning, preparation, writing, and review of aggregate reports, performing data analysis to evaluate safety signals, and providing scientific and compliance expertise to the Global Pharmacovigilance and Safety department.

Responsibilities:

• Direct the planning, preparation, writing, and review of portions of aggregate reports
• Organize and direct liaison activities with affiliates and other internal partners regarding products
• Support and provide oversight to staff with regards to safety in clinical trials, including reviewing protocols and statistical analysis plans
• Perform data analysis to evaluate safety signals and author Safety Assessment Reports and other regulatory responses
• Assist in the development of risk management strategy and activities, including providing content for and overseeing risk management plans
• Support activities related to new drug applications and other regulatory filings
• Serve as a representative and point of contact for Health Authority Inspections and Internal Process Audits

Requirements:

• Direct Pharmacovigilance experience (Not PV operation or safety reporting)
• Safety signal assessment and management experience
• Aggregate data review and assessment experience
• Bachelor's degree and 8 years of directly related experience OR Master's degree and 6 years of directly related experience OR Doctorate degree and 2 years of directly related experience
• Broad knowledge of Pharmacovigilance (PV) processes and regulations, drug development, and risk management
• Experience with safety data capture, safety database structure, and MedDRA
• Ability to analyze and interpret complex safety data
• Strong medical/scientific writing and verbal communication skills

Desired skills:

• Experience in a biotech/pharmaceutical setting
• Previous management and/or mentoring experience
• Intermediate skills in the application of statistical and epidemiological methods to pharmacovigilance
• Experience with literature surveillance and evaluation

Only candidates available and ready to work directly as ApTask Global Workforce (AGW) employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, please apply!

ApTask Global Workforce (AGW)
ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab, and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise, and a commitment to quality, speed, and consistent delivery.

Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website

ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.