Senior Product Manager, Pharmacovigilance Operations

Summary

Join AbbVie's International Strategy & Safety Operations (ISSO) function as a Senior Product Manager, focusing on the Oncology portfolio. You will oversee the accuracy and timeliness of safety operations activities, ensuring compliance with global regulations. Responsibilities include collaborating with cross-functional teams, providing regulatory support, and leading process improvements. The role requires a strong understanding of pharmacovigilance, drug development, and global regulatory requirements. This position offers a remote work option in the US and a comprehensive benefits package.

Requirements

• Bachelor’s degree with related health sciences background
• Licensed healthcare professional
• 2 years of previous experience as a Product Manager, or equivalent preferred
• At least 5 years’ experience working in the healthcare industry and a strong understanding of the drug development process
• Minimum of 3 years of pharmacovigilance experience required
• Strong understanding of the current global regulatory requirements that impact PV
• Proficient in case processing processes, procedures, conventions
• High emotional Intelligence and strong relationship management and communication skills
• Demonstrated ability to collaborate and influence cross-functionally and globally
• Proficient in the regulations in relation to the science for the benefit of drug safety
• Strong leadership presence and communication skills
• Strong influencing skills

Responsibilities

• Oversees the accuracy, completeness and timeliness of all Safety Operations scientific activities and deliverables for Oncology and/or focused disease state
• These activities/deliverables include support and input into the lifecycle of the asset (from pre-clinical, clinical trial and post- marketing deliverables), submissions and product launches, studies, scientific collaborations, etc
• The Sr. Product Manager is the point of contact for Product Safety Teams, QPPV and PPS Leadership contextualization of Adverse Event data (from an ICSR perspective) for focused therapeutic product and/or disease state for global regulatory responses, audits/inspections, proactive safety communications, etc
• Collaborates with Data Management or Business Technology to extract required data and reports
• Supports and provides guidance to the Safety Operations Product Managers to prepare communication materials that contextualize the data in a meaningful way in order to facilitate high-quality safety responses and narratives
• Partners with the Product Safety Team (PST) to provide input on study protocols, Urgent Safety Measures/Unanticipated Problems (USM/UP), animal and toxicology reports, global regulatory agency requests, and inspection support
• With oversight from Portfolio Lead, support the maintenance and identification of RSI responsibilities for assigned product
• May collaborate with cross-functional RSI stakeholders for periodic maintenance
• Leads effective cross-functional collaboration for focused therapeutic product and/or disease state with an emphasis on building business relationships with relevant AbbVie stakeholders, including Patient Safety, Commercial, GMA, RDQA, and Affiliates to establish and maintain harmonized ICSR processes
• Support cross-functional training requirements to support the Safety Operations Product Leadership (SOPROL) organization within ISSO
• Supports the ISSO stakeholders on acquisitions, outsourcing and collaboration initiatives within Oncology
• With oversight from Portfolio Lead, provides product oversight of outsourced studies by reviewing and contributing to the Safety Management Plans
• Participates in audits and inspections
• Prepares materials related to Adverse Event data and decisions, as it relates to product strategies
• Engages in front-room interviews
• Supports PST Leads, International PV Network and other stakeholder groups in preparation for audits and inspections
• Proactively communicates product-level insights on Adverse Event data (from an ICSR perspective) within ISSO
• Functions as the Safety Operations Sr. Product Manager for focused therapeutic product and/or disease state from discovery through approval for the life of the product
• Supports all types of studies including phase I through phase IV, Post marketing Observational Studies (PMOS), Investigator Initiated Studies (IIS), and collaborations studies
• Determines when PV blind breaks should be processed for end of study blind breaks
• Functions as a blind break decision maker for blind breaks due to safety concerns and health authority requests
• Assists the management of the Blind Break Process and provides input into proposed improvements and updates
• Evaluates for efficiencies gained
• Liaises with Global Medical Affairs (GMA) on GMA sponsored studies by providing input on safety data collection, protocol and contract review to ensure safety language is correct and in compliance with the global regulations
• Leads process improvement initiatives with effective change management and rapid solutioning of unanticipated issues related to SOPROL and/or product-related ICSR safety issues
• Leads identification, prioritization, and timely resolution of potentially impactful issues, including clear communication and follow-up across stakeholders through resolution, prevention, and trending related to SOPROL and/or product-related ICSR safety issues
• Provides input to Safety Operations ICSR forecasting process by providing relevant product-specific insights on studies (planned, active, completed), regulatory commitments and filings, anticipated approvals/launches, Patient Support Program strategies, etc

Preferred Qualifications

• RN, BSN, BS, BS Pharm, PharmD or advanced degree preferred
• Cross-functional initiative experience is preferred

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs