SR MED SAFETY ANALYST

Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.

PRIMARY JOB FUNCTION:
The Senior Safety Medical Analyst is responsible for the oversight of the adverse events and product experiences reported within a clinical trial. With supervision and oversight from a more senior member of the safety department, the Senior Safety Medical Analyst ensures the appropriate reporting of the events to the Clinical Research Department and applicable Regulatory Authorities throughout the life of the trial. The Medical Safety Monitor acts as the liaison between the Safety department and all other internal departments.

CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

· Participates in protocol review for safety input such as requirement of a CEC or DSMB, adverse event reporting requirements and endpoint determination.
· Participates in the formulation of case report forms, specifically with regards to reporting and management of adverse events.
· Assists with all activities related to establishing and managing all safety-related processes.
· Reviews all safety related data for various clinical trials.
· Reviews clinical safety databases; creating narrative reports for notable clinical events; assisting sites with subject evaluation and protocol adherence; and preparing safety reports to support regulatory notifications and filings.
· Serve as the main liaison between the different bodies involved in the safety process i.e. between the DSMB, CEC, CRO, investigators, and study team.
· Support preparation of periodic safety reports to the FDA and IRB/IECs.
· Support preparation of safety section of clinical study reports, Clinical Expert reviews, clinical section of device reports, and other ad hoc reports documents as needed to support formal (PMA) regulatory filings.
· Assist in formulating and implementing guidelines and processes in establishing independent safety monitoring boards and committees for clinical trials.

POSITION ACCOUNTABILITY / SCOPE:
· Will report to the Associate Director of Safety.
· Is responsible to support the budget goals of the safety department but not directly responsible for budgeting activities.
· Will have internal contact with applicable departments in regards to the activities of the clinical trial(s).
· With supervision and oversight from a more senior member of the safety department will have external contact with applicable committees (e.g., CEC, DSMB & CROs) in regards to the activities of the clinical trial(s).

Basic Qualifications:
5+ years experience preferred. Consider equivalent combination of education and work experience to ensure that employee has a strong clinical orientation and knowledge of diverse therapeutic categories.

· Adequate knowledge in reviewing, interpreting and reporting medical records.
· Adequate knowledge in reviewing and interpreting medical diagnostic tests.
· Excellent verbal and written communication skills
· Negotiation and presentation skills preferable
· Knowledge of FDA and ICH
· Regulations/Guidelines governing the reporting of adverse events strongly preferred.
· Experience using relational database applications for clinical trial management and safety management
· Experience in participating in safety review processes.
· Experience in participating in the conduct of clinical trials.
· Familiar with medical terminology and MedDRA
· Organizational skills & ability to direct and manage projects.
· Ability to manage multiple priorities
· Analytical, detail-oriented, and with ability to solve problems and multi-task.

Education Requirements: Bachelor’s degree and RN, BSN, Nurse Practitioner or Physician Assistant degree is required.

Relocation: No relocation assistance will provided.