Mediabistro logo
job logo

Associate Director, Safety Operations Portfolio

BioSpace, cambridge, ma, United States


About AbbVie

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 including immunology, oncology and neuroscience – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at

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 including immunology, oncology and neuroscience – and products and services in our Allergan Aesthetics portfolio.

Purpose

This position manages a team of Portfolio Leads and Product Leads who are responsible for Safety Operations‑related scientific activities, input and expertise across assets in all therapeutic areas. The role leads the SOPROL (Safety Operations Product Leadership) team, works with Therapeutic Area Heads and senior/executive scientific leaders across Global Patient Safety (GPS), Global Medical Affairs, Clinical Development and Regulatory Affairs. It ensures accurate, high‑quality and timely Safety Operations scientific input and support are provided to PSTs across assets from discovery to end of life. Safety Operations oversees the intake, processing, and reporting of patient safety information.

Responsibilities

  • Develop and implement the strategy for providing scientific expertise and support across all Safety Operations activities for assets, supporting PST responsibilities and deliverables, including regulatory responses, submissions and launches, audits/inspections, clinical trial protocol reviews, etc.
  • Oversee the accuracy, quality and timeliness of scientific input for the entire Safety Operations spectrum for pharmaceutical and device assets in development and on‑market.
  • Interpret and implement global regulations related to clinical trial and pharmacovigilance supporting all patient safety activities, collaborating with the QPPV Office on international regulatory requirements.
  • Build strong collaborative relationships with PST Therapeutic Area leadership, Group Medical Directors, and senior leaders in Epidemiology, Medical Aesthetics & Device Safety, Clinical Trial Safety & Insights to provide Safety Operations scientific recommendations that optimize safety strategies for high‑profile assets.
  • Maintain a comprehensive understanding of AbbVie's strategic pipeline and commercial priorities to inform ICSR forecasting and broader Safety Operations business planning.
  • Prepare GPS leadership communications to share critical insights from ICSR data across key assets.
  • Manage talent development and utilization of SOPROL Portfolio Leads and Product Managers, engaging, inspiring, coaching and mentoring the team.
  • Partner with senior scientific leadership across functions (Global Medical Affairs, Regulatory Affairs, Clinical Development, etc.) to advance SOPROL priorities and support high‑quality scientific decision‑making.
  • Manage audit and inspection preparedness, supporting PSTs and preparing Portfolio Leads and Product Managers for product SME direct participation in front and back rooms.
  • Represent VP Safety Operations in senior leadership scientific discussions on assets and serve on GPS scientific governance bodies as needed.
  • Perform SOPROL responsibilities for sensitive or confidential assets (e.g., related to acquisition deals and company partnerships).

Qualifications

  • Bachelor’s degree with a related health sciences background; licensed healthcare professional preferred (RN, BSN, BS, BS Pharm, PharmD or advanced degree).
  • At least 6 years of experience working in the healthcare industry and a strong understanding of the drug development process.
  • A previous pharmacovigilance leadership role is preferred.
  • Minimum 4 years of pharmacovigilance experience and 3 years of clinical development experience.
  • Significant experience leading cross‑functional teams on complex projects, driving major change initiatives, and influencing senior management.
  • High emotional intelligence, strong relationship management and communication skills.
  • Understanding of the connections between regulations and science for drug safety.

Additional Information

  • 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. Individual compensation will depend on many factors including geographic location, and may ultimately be more or less than the posted range.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick leave), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our short‑term incentive programs.

Note: No amount of pay is considered 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 that is attributable to a particular employee remains at the Company's sole discretion until paid and may be modified at the Company's discretion, in accordance 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.

US & Puerto Rico only – to learn more, visit

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

#J-18808-Ljbffr