Medical Director, Neuroscience, Global Patient Safety

AbbVie

North Chicago (IL)

On-site

USD 150,000 - 210,000

Full time

14 days+

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Benefits offered by this job

Medical insurance
Dental insurance
401(k) plan
Paid time off

Job summary

Allergan is seeking a PST Lead to guide Product Safety Teams and ensure robust safety monitoring across product lifecycles, including surveillance, signal detection, risk management, and regulatory communications. The role requires leadership of pharmacovigilance documents and collaboration with cross-functional teams and regulatory authorities.

Qualifications include an MD/DO with residency and 2–5 years in pharmacovigilance/clinical development, plus strong English communication.

Qualifications

  • MD/DO with 2+ years of residency with patient management experience.
  • 2‑5 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry.
  • Fluency in English, both written and oral.

Responsibilities

  • Lead Product Safety Teams (PST) and set strategy for pharmacovigilance activities across products.
  • Oversee safety surveillance for pharmaceutical/biologic/ drug-device products.
  • Develop and supervise safety documents including DSURs, PBRERs/PSURs, and PADERs and regulatory responses.
  • Apply current regulatory guidance to safety surveillance for products in development and on market.
  • Analyze aggregate safety data and present interpretations to cross-functional teams and regulatory authorities.
  • Author, review, and present technical pharmacovigilance documents.
  • Implement risk management strategies for assigned products.
  • Mentor and develop team members.

Skills

Pharmacovigilance
Clinical development
Cross-functional leadership
Regulatory communication
Medical writing

Education

MD/DO with residency in patient management
Master of Public Health (preferred)

Job description

Job Description

Purpose: To lead Product Safety Teams (PST) and support one or more products as the PST Lead, ensuring that the safety profile of one or more products is adequately monitored and characterized throughout the product lifecycle (e.g., surveillance, signal detection and evaluation, risk management, etc.). 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 combination products.
  • Lead, oversee, and set the strategy for key pharmacovigilance documents, including but not limited to medical safety assessments, regulatory responses, risk management plans, periodic safety reports (DSURs, PBRERs/PSURs, PADERs), etc.
  • Lead and oversee safety surveillance and pharmacovigilance activities for products in clinical development and marketed products, applying current regulatory guidance as appropriate.
  • Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross‑functional teams and regulatory authorities.
  • Effectively and independently write, review, and present technical documents.
  • Responsible for implementing risk management strategies for assigned products.
  • Proactively engaging, inspiring, coaching and mentoring team and colleagues.
Qualifications
  • MD / DO with 2+ years of residency with patient management experience.
  • Master Public Health is preferred in addition to MD / DO, not required.
  • 2‑5 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.
Benefits

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 long‑term incentive programs.

Equal Employment Opportunity Statement

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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

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