Senior Pharmacovigilance Specialist
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
Location: Sunnyvale, CA or South San Francisco, CA or Remote Location
Key Accountabilities / Core Job Responsibilities:
Perform end of line QC checks on a daily sampling of post marketing adverse event reports.
Mentoring third parties on accurate case processing based on Pharmacyclics case processing conventions and Drug Safety best practices.
Develop and deliver training to third parties on various post marketing operations topics, e.g. data entry conventions, MedDRA coding, adverse event selection.
Work with DSP IS team to request various reports from the safety database.
Prepare adverse event case quality and case processing information for trending, reporting, and presentation to third parties and Drug Safety management.
Investigate and resolve adverse event case questions.
Support development and management of Pharmacyclics and third party post marketing case processing procedures.
Assist with assessment and monitoring of root cause analysis/corrective action activities for third parties.
Assist with investigation and documentation of late case submissions.
Contribute to quality improvement and business optimization initiatives in Drug Safety Operations.
Maintain post marketing operations documentation in an audit-ready state and support audits/inspections.
Establish and maintain optimal relationships with internal and external stakeholders.
Demonstrate ability to apply previous experience and knowledge in performing daily activities.
May perform adverse event report reconciliation.
May assist with development of third party monitoring plans.
May facilitate and lead meetings with third parties.
Perform other activities as directed by management.
Bachelor's degree in nursing, other healthcare professional, or other degree in other related area with 3-5 years of experience in Drug Safety and Pharmacovigilance in the post marketing setting, or equivalent education/experience.
Experience with Oncology therapeutic area preferred.
Safety database experience required. Argus safety database experience strongly preferred.
MedDRA coding experience and certification highly desirable.
Demonstrated ability to work in a fast pace, cross-functional, complex environment.
Must be able to work well within a team as well as independently.
Ability to work effectively on multiple projects under tight timelines, maintain flexibility, adapt and prioritize as needed.
Must have excellent communication skills.
Must have strong analytical and problem-solving skills.