Senior Product Manager, Pharmacovigilance Operations (Remote)

Hispanic Alliance for Career Enhancement; North Chicago (IL); Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Product Manager to oversee safety operations within their oncology portfolio. This role involves ensuring the accuracy and completeness of safety deliverables, collaborating with cross-functional teams, and leading process improvements. The ideal candidate will have a strong background in pharmacovigilance and product management, with a passion for driving safety initiatives. Join a forward-thinking company that values innovation and integrity, and make a significant impact on patient safety and drug development processes.

Benefits

Medical/Dental/Vision Insurance

401(k) Plan

Paid Time Off

Short-term Incentive Programs

Long-term Incentive Programs

Qualifications

• Minimum of 3 years of pharmacovigilance experience required.
• Strong understanding of global regulatory requirements impacting PV.
• Demonstrated ability to collaborate and influence cross-functionally.

Responsibilities

• Oversees accuracy and timeliness of Safety Operations activities.
• Collaborates with Data Management to extract required data.
• Leads cross-functional collaboration for therapeutic products.

Skills

Pharmacovigilance

Product Management

Regulatory Compliance

Data Analysis

Cross-Functional Collaboration

Education

Bachelor's degree in Health Sciences

RN, BSN, BS Pharm, PharmD

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose:

This position reports into the Safety Operations Product Leadership team which is part of the International Strategy & Safety Operations (ISSO) function in Patient Safety. The Patient Safety organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand, and communicate the safety profile of our drugs to protect patients worldwide. ISSO oversees the intake, processing, and reporting of patient safety information.

Responsibilities:

With oversight of the Oncology Portfolio Lead, the Sr. Product Manager 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.

With oversight of the Portfolio Lead, responsibilities include:

• 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.

This role can be remote in the US.

Qualifications

Minimum: Bachelor's degree with related health sciences background; Licensed healthcare professional. RN, BSN, BS, BS Pharm, PharmD or advanced degree preferred.

• 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. Cross-functional initiative experience is preferred.
• Proficient in the regulations in relation to the science for the benefit of drug safety.
• Strong leadership presence and communication skills. Strong influencing skills.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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https://www.abbvie.com/join-us/reasonable-accommodations.html