Medical Director, Late Stage - Oncology (Remote)
- Full-time
- Salary Min: 195000
- Salary Max: 371000
- Therapy Area: Oncology
- Area of Interest: Pharmacovigilance
- Travel: Yes, 10% of the Time
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. For more information about AbbVie, please visit us at www.abbvie.com.
Responsible for supporting the Product Safety Leads (PST) and potentially support one or more products as the PST Lead under the direction of the Therapeutic Area (TA) Lead and Global TA Head in ensuring safety in one or more products through 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.
- Safety surveillance for pharmaceutical/biological/drug-device combined products.
- Contribute to the authorship of 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 analyses and interpretations to cross-functional teams.
- Ability to effectively write, review and provide input on technical documents.
- Lead 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.
- Lead and implement risk management strategy for assigned products.
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required. Frequent to continuous computer usage (greater or equal to 50% of the workday) is required.
The role can work remote in the US.
Minimum Requirements:
- MD / DO with 2+ years of residency with patient management experience and Master Public Health is preferred in addition to MD / DO but not required.
- 2 – 4 years of Pharmacovigilance experience in the pharmaceutical industry.
- Effectively analyze and guide analysis of clinical data and epidemiological information.
- Effectively present recommendations/opinions in group environments.
- Write, review and provide input on technical documents.
- Self-starting and can work independently.
- Work collaboratively and lead cross-functional teams.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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