Spectrum Pharmaceuticals, Inc.
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Director of Pharmacovigilance
at Spectrum Pharmaceuticals, Inc.
To be considered for this position, the candidate must possess relevant experience in safety (minimum of 15+ years of safety experience in both pre- and post-marketing safety reporting) along with 5-10 years supervisory experience. Experience in leadership, medical review of individual cases, aggregate safety reports production, (e.g. PSUR), RMP, safety signal detection and all safety related activities for company drugs under the direction of the Vice President of Pharmacovigilance.
- Responsible for managing all activities in the Pharmacovigilance department
- Ensure provision of a clearly defined safety strategy in the context of delivering the benefit-risk profile
- Ensure appropriate oversight of the emerging safety profile of the product including signal detection and evaluation, risk-benefit evaluation and risk management, and that any significant signals or safety issues are escalated appropriately within the company
- Perform the day-to-day medical review and medical assessment for individual cases received from clinical studies and post marketing sources
- Ensure the processing of expendable adverse events meet the required standard, and submitting these events to the clients and regulatory agencies within the agreed/stated timelines.
- Train new employees overall in pharmacovigilance and regulatory reporting
- Provide appropriate and relevant input into project management
- Liaise with medical, clinical, data management and regulatory personnel regarding safety issues, as appropriate
- Review and provide input on global Standard Operating Procedures (SOPs) and Work Instructions
- Work in/maintain complete understanding of ARGUS database conventions and system functionality
- Ensure timely preparation of aggregate safety reports, including PSURs, PBRERs, PADERs, and DSURs
- Manage CROs, including US and EU
- Represent Pharmacovigilance in Regulatory Agency inspections, as required
- Available for travel 15-20%
Required Skills, Education and Experience:
- MD degree
- 15 + years of drug safety experience in a pharmaceutical company
- Expert understanding of US, Canadian and EMA safety regulations
- Scientific writing skills
- Detailed knowledge in the use of drug safety databases
- Individual case-processing experience
- Strong communication skills to discuss individual cases with the clinical investigators
- Practical experience working with MedDRA
- Familiar with RMP development
- Time and project management skills
- Strong knowledge and experience in performing signal detection and data migration
- Previous US FDA inspection experience required; MHRA inspection experience desirable
- Ability to collaborate with partners and teams with members from multiple disciplines
Position Location and/or Territory and Travel
- Position is located in Irvine, CA
- Position may require occasional travel
Spectrum Pharmaceuticals is an equal opportunity employer, we evaluate qualified applicants without regard to race, color. Religion, sex, national origin, disability, veteran status, and other protected characteristics.