Post-Doctoral PharmD Fellow: Oncology Drug Safety

Post-Doctoral PharmD Fellow: Oncology Drug Safety

Summary:

The Seattle Genetics Drug Safety Fellowship is a one-year, experiential program at Seattle Genetics based in Bothell, WA. The purpose of this program is to prepare PharmD fellows for career opportunities in pharmaceutical Drug Safety by providing in-depth biopharmaceutical industry experiences and enhancing clinical knowledge.

The Drug Safety Fellowship at Seattle Genetics offers an opportunity to apply one’s clinical knowledge and analytical skills while gaining a thorough understanding of pharmacovigilance across the product life cycle. Fellows will work closely with the Drug Safety Evaluation and Risk Management Team in single case evaluation, aggregate data analysis, signal detection and assessments. Additionally, the fellow will the have opportunity to gain experience through strate­gic interactions with key cross-functional team members, such as Non-Clinical Development, Drug Safety Operations, Drug Safety Epidemiology, Clinical Development, Clinical Informa­tion Systems, Regulatory Affairs, and Medical Affairs. The fellow may support early stage and late stage Seattle Genetics’ programs. 

Responsibilities:

• Contribute to Pharmacovigilance and Risk Management planning for designated products
• Safety surveillance, track and evaluate potential safety issues
• Perform Project Management activities for multiple studies in a program
• Generate and complete a longitudinal project(s), with publication and/or presentation opportunities
• Develop and deliver presentations as needed to Drug Safety and other internal groups
• Support the RM lead in the development and/or execution of RMP or REMS risk mitigation activities
• Conduct/support signal detection and evaluation according to standard operating procedures and guidelines
• Prepare Safety Reports as necessary for safety signals or other issues (product quality)
• Safety content review of clinical protocols, study reports, informed consent forms, and Investigator Brochures for designated products
• Support the RM Lead in responding to safety requests for assigned product(s) from Regulatory Authorities, Affiliates, and other internal functions
• Attend weekly internal global safety team (iGST) meeting to relay safety concerns raised in Study Team/Clinical Sub Team Meetings
• Travel may include, but is not limited to, the annual ASHP meeting

Qualifications:

• A Doctor of Pharmacy (PharmD) degree from an ACPE accredited institution
• Relevant Internship or Clerkship experiences
• Prior clinical or industry experience is preferred
• Basic knowledge of the pharmaceutical industry including Drug Safety, Product Development, Manufacturing, Regulatory, Medical Affairs, and Commercial operations
• Prior oncology experience is preferred
• Completion of a PGY1 or PGY2 pharmacy residency is desirable
• Evidence of appropriate analytical, planning and organizational skills
• Possess good communication skills, including oral, written and presentation
• Self-motivated, energetic, able to work and learn independently
• Ability to thrive in a fast-paced, dynamic environment
• Good medical and scientific judgement, attention to detail, and excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

Application deadline is Wednesday, November 25^th. Please include include the following with your application:

• Curriculum vitae
• Letter of intent
• 3 Professional References (phone number and email) upon formal request