Sr. Manager- Pharmacovigilance Operations

JOB SUMMARY:

The Sr. Manager, Pharmacovigilance Operations provides functional area and operational support of assigned developmental and/or marketed product(s). This position will collaborate closely with the safety physician and cross-functional partners to evaluate and actively manage risks in accordance with global regulatory frameworks, contributes to safety-related reports (DSURs, PBRERs, PADERs, RMPs), assists with signal surveillance activities and literature surveillance, and contributes safety information to regulatory submissions. This position may also be cross-trained to participate in other regulatory functions.

PRINCIPAL DUTIES:

• Under the supervision of the Directors of Pharmacovigilance Operations, provide vendor oversight with focus on quality and regulatory compliance for submission of all pharmacovigilance-related information.
• Review aggregate safety reports for quality and content in conjunction with Regulatory Affairs.
• Supporting clinical trial and commercial teams, both internal and external.
• Supporting the PV owned Contact Center which receives both adverse events and product quality events
• Reviewing literature for identification of potential safety issues.
• Participates in departmental development activities including SOP and Work Instruction development, Audits / Inspections, and regulatory submissions.
• Assist in management and communication with external vendors responsible for case processing activities including quality review of all cases.
• Other duties as assigned.

REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS):

Education

• PharmD or advanced healthcare degree (MS, BSN), or equivalent professional experience preferred

Required/Essential

• US based
• Strong understanding of Quality Management, CAPA and Effectiveness Checks and risk based mitigation
• Attention to detail with excellent understanding of GxP requirements with respect to quality and compliance
• Minimum 5 years’ experience in Argus safety data base including case processing, quality review, narrative writing and query management.
• Ability to function in dynamic and evolving environment within a growing pharma organization
• Self-starter, able to jump in and offer solutions, ideas and best practices
• Minimum 5 years of experience in pharmacovigilance in the CRO setting, prefer 2-4 years in the Sponsor arena, or relevant experience including data analysis and vendor oversight.
• Ability to analyze, interpret, and summarize moderately complex data with general oversight.
• Exhibits firm comprehension of pharmacovigilance and drug development processes and requirements.
• Demonstrates strong ability to communicate effectively in a matrix environment.
• Exhibits ability to multi-task effectively, e.g., ability to complete work in a resourceful, self sufficient manner while maintaining a strong focus on the specific tasks demanding resources and attention.
• Demonstrates solid written and oral communication skills and sound attention to detail.
• Possesses computer skills to support use of electronic systems and development of writing deliverables.

Posted On: Thursday, December 19, 2024