Safety Monitor

Emmes Services Pvt. Ltd , ("Emmes") is searching for Safety Monitor in Clinical Research located in our Bangalore, India office. Emmes provides flexibility for office location preference, dependent upon position.

EMMES Services Pvt. Ltd, Bangalore, a fully owned subsidiary of The Emmes Company, LLC. Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over seven hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

The Safety Monitor is responsible for coordinating the safety aspects of projects in conjunction with
the Medical Monitor and the project team .

Responsibilities

Coordinates safety monitoring activities with Project Medical Monitor.

• Reviews safety events

o Provides first line evaluation of serious adverse events (SAEs).

o Communicates with site staff regarding reported AEs or SAEs to gather additional

information.

o Prepares a summary narrative for each reported SAE suitable for inclusion in DSMB

reports, regulatory submissions and final study reports.

o Maintains ongoing database of SAEs and reconciles SAEs in the database as needed.

o Reviews adverse events for the study on a regular basis

• Communicates with sponsor, investigator site staff, pharmaceutical and other study partners

o Responds to site, sponsor, pharmaceutical partner requests for information regarding

safety in clinical trials.

o Participates in Data Safety Monitoring Board (DSMB) or other safety review

committee (SRC) meetings as necessary

o Reviews and contributes to DSMB/SRC reports regarding safety; reviews and

contributes to safety sections of annual report, and periodic safety reports

• Coordinates with project staff

o Participates in project team meetings

o Participate in the planning, preparation, and development of all safety-related

sections of protocols, study specific Manual of Operations (MOP), project SOPs, and

ancillary documents to ensure project compliance with corporate SOPs

o Contribute to the development and implementation of the safety Case Report Forms

(CRF) and Safety Monitoring Plans (SMP).

o Maintains documentation required by corporate and project SOPs

o Participates in project process improvement and corporate quality assurance activities

through Internal Quality Audit Team (IQAT) processes, project SOP and

Compliance/Variance table development, participation in both internal and external

audits, as well as professional development activities.

• Performs MedDRA and WHO Drug coding, as applicable.

• Other corporate activities including annual SOP reviews, development and teaching EmmesU

classes, participation in corporate safety meetings/activities; and other corporate PV

activities.

• Other duties as assigned

Experience
  • BDS/MBBS or bachelor's degree in a scientific discipline with equivalent clinical experience
  • Demonstrated experience with clinical trial data collection and safety monitoring and years'
    experience in safety monitoring/pharmacovigilance commensurate with job leveling chart.
  • Working knowledge of MedDRA and WHO Drug coding preferred
  • Demonstrated use of medical terminology and ability to extract information to create a case history
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
  • Excellent oral and written communications skills
  • Ability to work as a team member and function on a cross-functional team


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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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