Director/Sr Medical Director, Medical Safety Evaluation, Immunology-Remote

ZipRecruiter; Philadelphia (Philadelphia County); Remote; USD 120,000 - 150,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking an Indication Product Safety Lead to oversee safety surveillance and risk management for key products. The role involves collaboration with cross-functional teams and requires strong analytical and communication skills. Candidates should hold an MD or DO and have substantial experience in pharmacovigilance or clinical development.

Qualifications

• 2+ years of patient management experience.
• 5-8 years of Pharmacovigilance / Clinical Development experience.

Responsibilities

• Lead safety surveillance of pharmaceutical products.
• Analyze and summarize safety data for cross-functional teams.
• Define and implement risk management strategies.

Skills

Analytical Skills

Communication

Collaboration

Decision-making

Education

MD / DO

Master of Public Health

Job description

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.

Job Description

Serve as Indication Product Safety Lead for one or more products under the direction of the Group Medical Director of Medical Safety Evaluation. Support assigned products with safety expertise throughout their lifecycle (including clinical development, marketing registration, and post-marketing), interpreting, summarizing, and presenting safety data in compliance with regulatory guidelines.

Responsibilities:

1. Understanding and application of pharmacology, chemistry, and non-clinical toxicology for effective safety surveillance.
2. Responsible for safety surveillance of pharmaceutical/biological/drug-device combined products.
3. Leading, setting strategy, and authoring key safety documents, including medical safety assessments, submission dossiers, and regulatory responses.
4. Applying current regulatory guidance for safety surveillance.
5. Analyzing, interpreting, and summarizing safety data; communicating findings to cross-functional teams and senior management.
6. Writing, reviewing, and providing input on technical documents.
7. Overseeing and strategizing for periodic reports (e.g., PSURs, DSURs, PADERs, IBs sections).
8. Collaborating with development medical leads on study protocols and informed consents.
9. Defining and implementing risk management strategies for assigned products/indications.
10. Mentoring team members and colleagues, and co-authoring publications to grow as a safety leader.

Significant Work Activities

• Prolonged sitting (more than 2 hours in an 8-hour day).
• Frequent computer usage (50% or more of the workday).

Qualifications

1. MD / DO with 2+ years of patient management experience; Master of Public Health is a plus but not required.
2. 5-8 years of Pharmacovigilance / Clinical Development experience or relevant background.
3. Strong analytical skills for clinical data and epidemiological information.
4. Effective communicator capable of presenting recommendations internally and externally.
5. Experience in technical document review and writing.
6. Ability to work collaboratively and lead cross-functional teams.
7. Decision-making independence.

Additional Information

Details about pay ranges, benefits, and legal disclosures are provided, emphasizing the company's commitment to equal opportunity and accommodations.