The primary job functions for this position include human safety surveillance related to pharmaceutical products and medical devices and risk identification and assessment in the therapeutic area of Women's Health. The analysis and interpretation of large amounts of safety data in specific therapeutic areas will be paramount, as will the written and oral communication of said analyses. The effective functioning of product safety teams is an important responsibility.
Safety Surveillance and Rick Identification and Assessment Risk Management - Apply current regulatory guidance for risk minimization to AbbVie’s product safety, RMP/REMS plans, as appropriate
Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing.
Understand assigned products’ pharmacology and chemistry from a safety perspective, relevant nonclinical toxicology and clinical AE profile.
Knowledge of clinical AE profile ranges from familiarity with individual case safety reports for assigned products to comprehension of aggregate safety data across clinical trials.
Develop core knowledge of adverse events commonly associated with pharmaceutical agents- including long QT syndrome, hepatotoxicity, bone marrow toxicity, drug-drug interactions, nephrotoxicity and immunogenicity- and expertise in one of these topics. (Expertise demonstrable by ability to serve as internal consultant.)
Ability to collaborate with internal and external relevant parties and develop a comprehensive risk management strategy for each of these topics.
Assist MSE and PV management in developing novel methods for signal detection using aggregate data from clinical trials, post market studies,, epidemiological investigations and literature.
Track known safety issues and potential safety concerns throughout the products’ lifecycle (Product Safety Plan).
Communicate new safety issues or potential safety concerns to PV management and PST as necessary.
Spearhead efforts at the clinical team/PST level to further characterize and describe safety issues or potential safety concerns prior to NDA filing and foresee and help initiate post marketing opportunities for risk mitigation
Evaluate potential safety signals through signal work-up:
Characterize the signal work-up on safety topics for assigned product requested by internal (AbbVie) and external (e.g., Regulatory agencies, etc.)
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Qualifications
Qualifications:
Basic:
Medical Doctorate degree or equivalent with relevant therapeutic specialty in an academic or hospital environment required.
Residency with direct patient management and care in patients in the following areas, e.g., Internal Med, Oncology, Cardiology, Infectious diseases, is preferred.
At least 5 years of clinical trial or medical affairs experience in the pharmaceutical industry or equivalent.
Proven leadership skills in a cross-functional global team.
Ability to interact externally and internally to support a global business strategy.
Preferred:
Completion of residency and/or fellowship is preferred
Board certified is preferred
US-trained and Board eligible or Board certified is preferred. MPH is desirable
Key Leadership Competencies:
Ability to serve as internal consultant and collaborate with internal and external relevant parties.
Demonstrated experience in leading a small multi-disciplinary business team (or sub-team) consisting of 4-6 members.
Demonstrated experience in leading the medical review of premarketing and/or postmarketing data, and writing high quality technical reports.
Demonstrated experience in assuming primary responsibility for assembling the safety sections of responses to health authority questions for a drug product.
Effective oral presentation and communication skills.
Significant Work Activities and Conditions
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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