Medical Review Specialist

at  AbbVie

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 Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description

Apply medical expertise and provide guidance for individual case safety report (ICSR) assessment, quality and reporting to ensure patient safety and achieve compliance with corporate and departmental Standard Operating Procedures (SOPs), global regulations. Responsible for medical review and safety surveillance of ICSRs, for development and marketed products as well as medical assessment of aggregate safety data and review of and safety reference documents. Provide guidance and coaching to Scientists within Operations.

• Perform Medical Review of adverse event reports including but not limited to all serious, event of interest and expedited individual case safety reports
• Ensure that appropriate medical interpretation, consistency and quality are applied to adverse event case assessment.
• Performs review of ICSR coding (e.g. reaction, suspect/concomitant product, indication, laboratory data, medical history)
• Confirm seriousness, expectedness/ listedness and reporter/partner causality of each event in the ICSR.
• Evaluate seriousness of non-serious events.
• Provide company causality assessment, where required; generate pharmacovigilance comments.
• Interact with Medical Safety Physicians on a regular basis to discuss individual case medical assessments and notification of potential signals.
• Provide medical guidance and opinions to PV scientist in the evaluation and follow-up of individual case safety reports. Provide medical input for ad-hoc queries as requested.
• Contribute to safety issue evaluation and management for the life cycle of product
• Contribute to signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from individual case safety report assessment.
• Prepares and may present individual case safety report issues for discussion at internal company meetings
• Collaborates with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, and other related departments
• Provides support as needed for licensing activities, regulatory authority inspections
• Contribute to pharmacovigilance analyses and ad-hoc report review.
• Participate in development and maintenance of CPDs.
• Ensure compliance with relevant regulations, guidelines and internal SOPs.
• Identify opportunities for continuous process improvement and recommend strategies to improve performance.

QUALIFICATIONS

• MD/DO required
• MBA or MPH (Master’s of Public Health) is a plus
• 1-2 years of experience in pharmaceutical industry within Drug Safety (Medical Review of ICSRs)/Pharmacovigilance (safety signal detection, data mining techniques, pharmacovigilance databases, etc.)
• 1-2 years’ experience with collection and reporting of Serious Adverse Events (SAE’s) associated with investigational drugs (i.e. SAE’s from Clinical Trials) as well as all post-marketing AE’s
• 2 years of Clinical Patient Care experience preferred
• Experience managing complex safety issues.
• Management Plans and REMS
• Knowledge of Pharmacovigilance as well as understanding/knowledge of the following areas:
• Medicine and Clinical Practice
• Epidemiology, Statistics, Physiology
• Clinical Trials, Drug Development
• Regulatory Affairs, Pharmacology
• Medical Coding and MedDRA
• In depth working knowledge of global pharmacovigilance regulations.
• Product safety issue evaluation/management (e.g. labeling negotiation) preferred
• Experience in the preparation of risk management plans, aggregate reports and company core safety information desirable
• Understanding and expertise in medical writing
• Drug safety database knowledge is required: ARGUS experience and navigation skills preferred
  Additional Information
  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.
  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.htm

• Perform Medical Review of adverse event reports including but not limited to all serious, event of interest and expedited individual case safety reports
• Ensure that appropriate medical interpretation, consistency and quality are applied to adverse event case assessment.
• Performs review of ICSR coding (e.g. reaction, suspect/concomitant product, indication, laboratory data, medical history)
• Confirm seriousness, expectedness/ listedness and reporter/partner causality of each event in the ICSR.
• Evaluate seriousness of non-serious events.
• Provide company causality assessment, where required; generate pharmacovigilance comments.
• Interact with Medical Safety Physicians on a regular basis to discuss individual case medical assessments and notification of potential signals.
• Provide medical guidance and opinions to PV scientist in the evaluation and follow-up of individual case safety reports. Provide medical input for ad-hoc queries as requested.
• Contribute to safety issue evaluation and management for the life cycle of product
• Contribute to signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from individual case safety report assessment.
• Prepares and may present individual case safety report issues for discussion at internal company meetings
• Collaborates with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, and other related departments
• Provides support as needed for licensing activities, regulatory authority inspections
• Contribute to pharmacovigilance analyses and ad-hoc report review.
• Participate in development and maintenance of CPDs.
• Ensure compliance with relevant regulations, guidelines and internal SOPs.
• Identify opportunities for continuous process improvement and recommend strategies to improve performance