Cubist Pharmaceuticals (NASDAQ: CBST) is a biopharmaceutical company focused on the research, development and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment.
Founded in 1992, Cubist is headquartered in Lexington, MA. 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 fieldProficiency with Microsoft Office and general technology applications Desired Competencies and Qualifications: Experience with safety data management including commercial safety databasesExperience in the biopharmaceutical industry is preferredAbility to work effectively as an individual contributor and as project team member; collaborative spiritAttention to detailAbility 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 Cubists established policies and procedures and ensures alignment of their work with Cubists values.
Physical Demands: None 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 positions essential functions.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Total Rewards: Our outstanding total rewards package includes: competitive base salary; annual incentive plan with payouts based on results; company-wide performance based equity program; choice of medical plan; dental, life and disability insurance; employee assistance program; flexible spending accounts; 100% vesting in our 401K plan with a competitive company match; employee stock purchase plan; tuition reimbursement; 12 paid holidays, 4 of which are floating; 3 weeks vacation; flexible work schedules; comprehensive reward and recognition program.
Application instructions: We encourage you to apply to Cubist by applying directly at: http://hostedjobs.
openhire.
com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=216737&company_id=15975&jobboardid=24 Submitting a resume online at a job site could cause valuable screening information to be missed.
We are an Equal Opportunity Employer.
Note to Recruiters: Relationships with professional recruiters are essential to the recruitment and staffing efforts at Cubist and we value the partnerships we have built with our preferred vendors.
We are also interested in establishing new relationships with experienced life science recruiters.
In order to recruit on Cubists behalf, each recruiting firm needs to have a written contract in place and agree to present candidates directly to Human Resources.
Associate, Pharmacovigilance (6310) Job in Lexington 02421, Massachusetts US