Opening for Life science / Pharmacy Freshers for Medical Surveillance - Assoc post @ Quintiles
Quintiles is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions – from pipeline through portfolio to population health™. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.
Job Title : Medical Surveillance - Assoc 1-1513560
Job Description :
Under Supervision, provide a wide range of medical surveillance support including monitoring of clinical laboratory data for subjects in clinical studies, composing medical narratives and interfacing with investigator sites.
RESPONSIBILITIES :
Under supervision evaluating and analyzing laboratory results on a daily basis from sponsor designated central laboratory using sponsor-designated data management system.
Under Supervision conduct the monitoring of laboratory safety parameters for each patient at every site throughout clinical drug trial.
Under Supervision conducts preliminary review of laboratory results relative to established protocol-specific reference range guidelines.
Follow established procedure for comparing current results with prior laboratory values to identify trends or potentially clinically significant increases/decreases.
Under supervision, contact the investigator site for pertinent additional clinical assessment and consults with Sponsor/Quintiles physicians for medical evaluation of case, as needed.
Under supervision, reviews and evaluates retest results and initiates contact with investigative site, if appropriate.
Composes telephone reports documenting site contact to include all clinically relevant information. Distributes according to scheme designated at project inception.
Assists Medical Surveillance Specialist with project set-up activities.
Attends investigator/study start-up meetings as requested by Sponsor and/or Quintiles physicians.
Maintains up-to-date laboratory knowledge via continuing education activities( like completion of continuing education class, applicable QU courses review of journal articles) or attendance at medical seminars.
Attends project team meetings, as needed.
Performs other related duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES :
Basic Knowledge of Medical /Scientific Terminology
Basic knowledge of applicable research and regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines
Excellent organizational, communication and computer skills required.
Ability to exercise excellent attention to detail.
Ability to act independently and with initiative required to resolving problems.
Strong analytical skills
Strong Excel Skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Eligiblity : Bachelor's/Master’s degree in Life science / Pharmacy
Experience : Upto 1 year
Click here to apply
Quintiles is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions – from pipeline through portfolio to population health™. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.
Job Title : Medical Surveillance - Assoc 1-1513560
Job Description :
Under Supervision, provide a wide range of medical surveillance support including monitoring of clinical laboratory data for subjects in clinical studies, composing medical narratives and interfacing with investigator sites.
RESPONSIBILITIES :
Under supervision evaluating and analyzing laboratory results on a daily basis from sponsor designated central laboratory using sponsor-designated data management system.
Under Supervision conduct the monitoring of laboratory safety parameters for each patient at every site throughout clinical drug trial.
Under Supervision conducts preliminary review of laboratory results relative to established protocol-specific reference range guidelines.
Follow established procedure for comparing current results with prior laboratory values to identify trends or potentially clinically significant increases/decreases.
Under supervision, contact the investigator site for pertinent additional clinical assessment and consults with Sponsor/Quintiles physicians for medical evaluation of case, as needed.
Under supervision, reviews and evaluates retest results and initiates contact with investigative site, if appropriate.
Composes telephone reports documenting site contact to include all clinically relevant information. Distributes according to scheme designated at project inception.
Assists Medical Surveillance Specialist with project set-up activities.
Attends investigator/study start-up meetings as requested by Sponsor and/or Quintiles physicians.
Maintains up-to-date laboratory knowledge via continuing education activities( like completion of continuing education class, applicable QU courses review of journal articles) or attendance at medical seminars.
Attends project team meetings, as needed.
Performs other related duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES :
Basic Knowledge of Medical /Scientific Terminology
Basic knowledge of applicable research and regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines
Excellent organizational, communication and computer skills required.
Ability to exercise excellent attention to detail.
Ability to act independently and with initiative required to resolving problems.
Strong analytical skills
Strong Excel Skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Eligiblity : Bachelor's/Master’s degree in Life science / Pharmacy
Experience : Upto 1 year
Click here to apply
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