Abbott Senior Safety Specialist in Plymouth, Minnesota

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

We are seeking an experienced, high caliber, Senior Clinical Safety Specialist who will work under the direction of the Medical Safety Manager, Medical/Scientific Affairs processing adverse events as defined per clinical protocols. This role will also assist with the education of clinical teams on identification and reporting of adverse events specific to clinical research projects.

Job Duties:

• Process all adverse events per Work Instruction/ Protocol, working collaboratively with study specific CRAs to ensure comprehensive information is available for full review and reporting

• Collaborate with Safety team members in preparation for DMC/DSMB/CEC meetings

• Oversee weekly review of adverse events with applicable study teams

• Review all adverse events in accordance with the specified Clinical Investigation Plan (CIP)

• Code adverse events where directed by the governing processes

• Draft AE narratives, as required, for inclusion in all FDA report submissions

• Work with clinical study teams to ensure adherence to protocol, regulations and SJM policies regarding the reporting of adverse events

• Maintain knowledge of current FDA, ICH, and ISO regulatory rules and policies affecting CVD Clinical study related products

• Assist with training on study specific adverse event definitions prior to start of clinical study/registry and ongoing as needed to insure compliance and accurate reporting

• Assist with revision or writing of SOP/Instructions/Procedures and changes to support clinical department

• Assist in development of study specific case report forms

• Assist in clinical study protocol development

• Assist with BIMO audits, when directed

• Collaborate on additional Clinical Research activities, as needed

• Other duties as assigned

Required Qualifications:

• Bachelor’s degree in an area of science or RN

• Strong understanding of adverse events and risk assessment

• 2-5 years of experience within pharmacovigilance or medical safety or 5+ years of experience in medical device or Pharma in clinical research or risk assessment

• Working knowledge of medical terminology, clinical research conduct, laws, regulations, and standards

• Proficient in MS Office and database navigation skills

• Strong interpersonal and communication skills

• Excellent record keeping, organizational skills, and problem solving abilities

• Highly motivated and capable of working independently and as a team member

• Experience coordinating, prioritizing, and setting timelines for multiple tasks

• Ability to multi-task and adapt to a rapid pace environment

• Strong technical writing skills

Preferred Qualifications:

• 3-5 years of experience in a hospital or clinic setting, preferably within the cardiovascular or neuromodulation areas

• PharmD or PhD

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com