Associate, Pharmacovigilance

Position Summary:
This position works in a team-oriented environment and will be responsible for assisting with adverse event case administrative functions including receiving and distributing adverse event reports for investigational and marketed products, coordinating adverse event report activities with other members of the group, creating adverse event case files and entering data into the safety database, submitting reports to regulatory authorities, distributing queries and tracking follow-up information received, and coordinating case closure including reconciliation of case-related documents. Additional responsibilities will include monitoring compliance and additional quality metrics, performing independent quality reviews of adverse event reports, assisting with or performing independently data reconciliation with other internal groups and external business partners, assisting with writing and maintaining standard operating procedures and guidelines for case processing operations, providing support for aggregate reporting, serving as controlled documentation outreach coordinator, and participating in company project teams.

Minimum Basic Qualifications:
• Bachelor of Science degree in Life Sciences or related health field
• Proficiency with Microsoft Office and general technology applications

Desired Competencies and Qualifications:
• Experience with safety data management including commercial safety databases
• Experience in the biopharmaceutical industry is preferred
• Ability to work effectively as an individual contributor and as project team member; collaborative spirit
• Attention to detail
• Ability to independently identify problems and effectively offer solutions
• Excellent interpersonal, communication, and personal organization skills; ability to prioritize workload and work effectively, sometimes within resource constraints

Work Environment:
• This is a Lexington-based position that requires significant interactions with internal colleagues from other departments and with external colleagues and consultants. Works within Cubist’s established policies and procedures and ensures alignment of their work with Cubist’s values.

Physical Demands:
• None

Application instructions:

We encourage you to apply to Cubist directly at:

https://hostedjobs.openhire.com/epostings/submit.cfm?fuseaction=app.jobinfo&id=23&jobid=216737&company_id=15975&version=1&source=ONLINE&JobOwner=968582&level=levelid1&levelid1=45729&parent=Clinical%20Development%20and%20Medical%20Affairs&startflag=2

We are an Equal Opportunity Employer.


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.