Head of Multiple Myeloma & AML, Oncology - Global Patient Safety

Actox; Boston (MA); Hybrid; USD 180.000 - 280.000; Vollzeit

Zusammenfassung

AbbVie seeks a senior medical director to lead Product Safety Teams (PST) and oversee safety across product lifecycles, including surveillance, signal detection, and risk management plans. The role requires MD/DO with extensive pharmacovigilance and cross-functional leadership experience, and fluency in English.

Responsibilities include strategy development for PV documents, PSURs/PADERs, and coordination of safety activities in trials and post-marketing.

Qualifikationen

• MD/DO with 2+ years of residency with patient management experience.
• Master Public Health is preferred in addition to MD/DO, not required
• 8 - 10 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
• Effectively analyze and guide analysis of clinical data and epidemiological information
• Effectively present recommendations / opinions in group environment both internally and externally
• Write, review and provide input on technical documents
• Work collaboratively and lead cross-functional teams
• Ability to lead cross-functional teams in a collaborative environment
• Fluency, both written and oral, in English
• Evaluate and make independent decisions. Ability to work effectively in the situation of uncertainty and complexity, ability to multitask

Aufgaben

• Understand and apply pharmacology, chemistry and non-clinical toxicology for safety surveillance
• Responsible for safety surveillance for products
• Lead strategy for pharmacovigilance documents and risk management plans
• Apply regulatory guidance for PV documents
• Analyze and interpret aggregate safety data and communicate to cross-functional teams
• Lead PSURs, PADERs and related reports
• Oversee safety surveillance for products in trials and post-marketing
• Implement risk management strategies for assigned products
• Mentor and coach team members
• Coordinate safety activities across indications and products

Kenntnisse

MD/DO residency

Leadership

Pharmacovigilance

Cross-functional leadership

English fluency

Ausbildung

MD/DO degree

Master of Public Health (preferred)

Jobbeschreibung

Company Description

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 www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors, and Executive Medical Directors. Leading Product Safety Teams (PST) and support one or more products as the PST Lead and ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities.

Responsibilities

• Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
• Responsible for safety surveillance for pharmaceutical / biological / drug -device combined products
• Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
• Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
• Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams
• Effectively write, review and provide input on technical documents independently
  Oversight and responsibility for leading the strategy for periodic reports (PSUR's, PADER's etc.)
• Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing
• Responsible for implementing risk management strategies for assigned products
• Proactively engaging, inspiring, coaching and mentoring team and colleagues
• Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management, coaching and development.
• Assumes responsibility for coordinating and overseeing safety related activities at a product level across multiple indications or multiple related products for the same indication. Is responsible for assessing product safety strategy across the entire program and for overseeing approval related activities.

Qualifications

• MD / DO with 2+ years of residency with patient management experience
  Master Public Health is preferred in addition to MD / DO, not required
  8 - 10 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
• Effectively analyze and guide analysis of clinical data and epidemiological information
• Effectively present recommendations / opinions in group environment both internally and externally
• Write, review and provide input on technical documents
  Work collaboratively and lead cross-functional teams
• Ability to lead cross-functional teams in a collaborative environment
  Fluency, both written and oral, in English
• Evaluate and make independent decisions. Ability to work effectively in the situation of uncertainty and complexity, ability to multitask

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 thisposting 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 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 anduntil 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html