Senior Product Manager, Pharmacovigilance Operations (Remote)

Lensa; North Chicago (IL); Remote; USD 100,000 - 150,000; Full time

Job summary

A leading company in the healthcare sector is seeking a Senior Product Manager for Pharmacovigilance Operations. This remote role involves overseeing safety operations, managing product safety data, and collaborating with cross-functional teams to ensure compliance with regulatory requirements. Ideal candidates will have a strong background in healthcare, product management, and pharmacovigilance, along with excellent communication and leadership skills.

Qualifications

• At least 2 years of product management experience preferred.
• Minimum of 5 years in healthcare with strong understanding of drug development.
• At least 3 years of pharmacovigilance experience.

Responsibilities

• Manage accuracy and timeliness of Safety Operations activities related to Oncology.
• Serve as primary contact for Product Safety Teams regarding adverse event data.
• Lead cross-functional collaborations to harmonize ICSR processes.

Skills

Emotional intelligence

Relationship management

Communication

Collaboration

Influencing skills

Education

Bachelor’s degree in health sciences or related field

Licensed healthcare professional (RN, BSN, PharmD)

Job description

Senior Product Manager, Pharmacovigilance Operations (Remote)

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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 TikTok (https://www.tiktok.com/@abbvie).

Purpose

This position reports into the Safety Operations Product Leadership team within the International Strategy & Safety Operations (ISSO) in Patient Safety. The Patient Safety organization collaborates across the product lifecycle to monitor and communicate drug safety to protect patients worldwide.

Responsibilities

Under the oversight of the Oncology Portfolio Lead, the Sr. Product Manager manages the accuracy, completeness, and timeliness of Safety Operations activities related to Oncology and/or specific disease states, including support across the product lifecycle, regulatory submissions, and scientific collaborations.

Key Responsibilities include:

• Serving as the primary contact for Product Safety Teams, QPPV, and PPS Leadership regarding adverse event data (ICSRs) for regulatory responses, audits, and safety communications.
• Collaborating with Data Management or Business Technology to extract necessary data and reports.
• Guiding Safety Operations Product Managers in preparing communication materials to ensure high-quality safety responses.
• Partnering with the Product Safety Team on study protocols, safety measures, and regulatory requests.
• Supporting maintenance of RSI responsibilities and collaborating with cross-functional stakeholders.
• Leading cross-functional collaborations to harmonize ICSR processes with stakeholders across functions and geographies.
• Supporting training and onboarding within the Safety Operations organization.
• Participating in audits and inspections, preparing relevant safety data materials, and engaging in interviews.
• Communicating product-level safety insights proactively within ISSO.
• Managing safety operations from discovery through product lifecycle, including various study phases and post-marketing studies.
• Making decisions on PV blind breaks and managing the process for safety concerns.
• Collaborating with Global Medical Affairs on safety data and study protocols.
• Leading process improvement initiatives and managing safety issues proactively.
• Providing input into safety forecasting and planning based on study and regulatory data.

This role can be remote in the US.

Qualifications

• Bachelor’s degree in health sciences or related field; licensed healthcare professional (RN, BSN, BS, PharmD, or higher preferred).
• At least 2 years of product management experience (preferred).
• Minimum of 5 years in healthcare with a strong understanding of drug development.
• At least 3 years of pharmacovigilance experience.
• Knowledge of global regulatory requirements impacting PV.
• Proficiency in case processing and safety data procedures.
• Strong emotional intelligence, relationship management, and communication skills.
• Ability to collaborate and influence cross-functionally and globally.
• Understanding of drug safety science and regulations.
• Strong leadership and influencing skills.

Additional information about compensation, benefits, and equal opportunity employment is provided in the original description.