Global Head of Oncology Patient Safety & PV

AbbVie Inc.; Boston (MA); On-site; USD 188,000 - 505,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) retirement plan

Paid time off

Job summary

AbbVie is seeking a seasoned Head of Multiple Myeloma & AML, Oncology - Global Patient Safety to lead safety strategy and team efforts across the product lifecycle. You will supervise senior medical directors and ensure rigorous pharmacovigilance for oncology programs in a global context.

The role calls for directing safety surveillance, regulatory communications, and risk management plans while collaborating with clinical development, regulatory, and medical affairs teams to protect patients

Qualifications

• MD/DO with 2+ years of residency and patient management experience.
• Master of Public Health is preferred in addition to MD/DO, not required.
• 8–10 years of Pharmacovigilance/Clinical Development experience in pharma.

Responsibilities

• Lead safety surveillance for products through the lifecycle (surveillance, signal detection, validation).
• Develop and oversee PV documents (medical safety assessments, regulatory responses, risk management plans).
• Oversee PSURs and other periodic reports; coordinate safety activities across indications or products.

Skills

Pharmacovigilance

Cross-functional leadership

Team mentoring

Education

MD/DO

MPH preferred

Job description

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

• Full-time
• Salary Min: 188000
• Salary Max: 504500
• Workday Global Grade: 24
• Compensation: USD 188,000 - USD 504,500 - yearly

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.

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
• 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.
• 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

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

The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof thisposting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless anduntil paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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 applicants seeking a reasonable accommodation, click here to learn more:

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