Manager, Drug Safety & Pharmacovigilance

This position supports drug safety and pharmacovigilance operation activities in both clinical trials and post marketing settings. In this role, the individual will be primarily responsible for ensuring end to end safety reporting requirements and processes are established and maintained for clinical trials (phase 1-4).  This role will also support post marketing safety operation activities, as needed.

Core Responsibilities: 

• Support the oversight of drug safety/pharmacovigilance service providers to ensure collection, processing, reporting and reconciliation of adverse events reports is compliant with global regulatory requirements and standard operating procedures (SOPs)
• Serves as a Safety Operations Lead on study management team(s).
• Create/revise and implement department SOPs, work instructions, and Safety Management Plans (SMPs).
• Develop and deliver training for safety related topics for internal personnel and external vendors.
• Perform in line and/or end of line quality review of adverse event reports.
• Support process improvement initiatives and safety systems implementation/maintenance activities.
• Ensure the clinical trial master file (TMF) is maintained in an inspection ready state for all safety related documents.
• Support and participate in audits and inspections, including preparation activities.
• Assist with safety operations and/or safety science projects, as necessary.

Required Skills, Qualifications and Technical Proficiencies:

• Knowledge of Argus (or similar safety applications), electronic data capture systems, and MedDRA and WHO Drug coding dictionaries.
• Excellent communication and collaboration skills in a multidisciplinary team.
• Ability to work independently and manage multiple projects in a dynamic, fast-paced environment to meet patient and corporate needs.
• Able to occasionally work extended and/or flexible schedule to meet corporate needs.

 Education and Experience:

• Bachelor's degree in healthcare or life sciences- degree such as RN or BSN, PharmD is preferred.
• Minimum of 5 years Drug Safety/PV experience in a global environment
• Experience in both clinical and post marketing safety operations preferred.
• Working knowledge of FDA, EU and ICH guidelines for safety reporting and processing for clinical trials and post marketing

The pay range that the Company reasonably expects to pay for this position is $147,000 - $173,000; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education.  An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and/or other wellness benefits, dependent on the position offered. 

Applicants must be currently authorized to work in the United States on a full-time basis.

If you are based in California, we encourage you to read this important information for California residents linked here.