Medical Director/Senior Medical Director, Pharmacovigilance

Employer
AbbVie
Location
North Chicago, IL
Posted
Nov 21, 2018
Ref
1805471
Required Education
Doctorate/PHD/MD
Position Type
Full time
The primary job functions for this position include human safety surveillance related to pharmaceutical products and medical devices and risk identification and assessment. 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.

Key Responsibilities Include:

• Define, lead and execute the safety strategy within ADTs/ GMATs/ PSTs for products for which he/she is functioning as the PST lead.
• Contributes to the strategy and authorship of key pharmacovigilance documents including but not limited to White papers, regulatory responses, risk management plans and the components of the BRPA.
• Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing. Safety Surveillance and Risk Identification and Assessment Risk Management - Apply current regulatory guidance for risk minimization to AbbVie's product safety, RMP/REMS plans, as appropriate. Lead and implement the risk management strategy for assigned products.
• 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.
• Responsible for the mentorship of colleagues on PST both on product knowledge but additionally on the safety strategy for pharmacovigilance.
• Responsible for execution of surveillance and signal detection for assigned products in collaboration with Aggregate safety and Medical analytics.
• Safety Surveillance and Risk 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.)

Qualification:

• 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, Neurology, Immunology, Infectious diseases, is preferred.
• A minimum of 2 years' experience in drug safety within the pharmaceutical industry. Clinical development or clinical research experience is preferred.
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.