Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Mumbai

Description

Team Lead - CDM/PV
Qualification:
Graduate/Post Graduate/ Doctorate degree in life sciences/Pharmacy/Medical sciences/Registered Nurse
Responsibility:
Business/ Customer:
• Minimal Customer interaction under guidance.
• Understands Domain Process/sub process, functions, terminologies (such as SOP, QC checklists).
For PV/Complaints Management :
• Individuals in this role perform data entry of data received from Source documents into the respective Clinical/Safety database While peroforming this activity the associate is responsible for meeting turnaround times and accuracy.
• These associates are usually used to handle more critical/senitive transactions.
• These associates also act as Subject Matter Expert.
CODING:
Perform coding activities on the assigned project with timelines and efficiency
• • Import uncoded terms in database and export coded medical terms from coding platform.
• • Query Management.
• • Create “New Term Request†and prioritize.
• • Perform Dictionary upversioning activity.
• • Send Coding (Consistency) Reports.
• • Participate in study related meetings as needed.
• • Provide feedback on quality related issues to other medical coders in timely manner.
• • Serve as an SME to Medical Reviewers regarding coding activities & guidelines.
• • Perform UAT for coding related applications.
• • Perform Operational QC.
• • Mentor Team Member.
• • Coordinate with CDM working on the same study.
• • Coordinate to resolve Rave specific issues.
CDM:
• 1 Execute Data Management Activities ie Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities.
• 2 Participate in innovation and process improvement initiatives.
• 3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs.
• 4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information.
• 5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required.
Project / Process:
• Attempts Complex problems (procedures/processes) and refers to Supervisor/Line Manager in rare cases.
• Handle first level processing of transactions.
• Adhere to quality requirements, achieve targets/volumes in given TAT(Turn around time).
• Proactively identify issues.
• Contribute to process improvement initiatives.
• Identify and report process changes.
• Adhere to the mandatory industry regulation and compliance requirements for the given process.
Knowledge Management:
• Update Process documentation as appropriate for the process under guidance.
• Participate in knowledge transfer.
People/Team Management:
• Adhere to org hygiene and compliance needs in terms of.
• a Personal Utilization & Time sheet submission.
• b Personal and new hire Assimilation.
• c Attendance.
• d Team Initiatives.
• Collate team performance metrics.
• Manage break schedule/transport logistics for the team in the absence of his/her supervisor.
Domain Skills
SNo
Primary Skill
Proficiency Level *
Rqrd./Dsrd.
1
Pharmacovigilance&Safety Ops
NA
Desired
2
PV Case Processing
NA
Desired
* Proficiency Legends
Proficiency Level
Generic Reference
PL1
The associate has basic awareness and comprehension of the skill and is in the process of acquiring this skill through various channels.
PL2
The associate possesses working knowledge of the skill, and can actively and independently apply this skill in engagements and projects.
PL3
The associate has comprehensive, in-depth and specialized knowledge of the skill. She / he has extensively demonstrated successful application of the skill in engagements or projects.
PL4
The associate can function as a subject matter expert for this skill. The associate is capable of analyzing, evaluating and synthesizing solutions using the skill.
Employee Status :
Full Time Employee
Shift :
Day Job
Travel :
No
Job Posting :
May 13 2019
About Cognizant
Cognizant (Nasdaq-100: CTSH) is one of the world's leading professional services companies, transforming clients' business, operating and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build

About the company

Cognizant (NASDAQ: CTSH) is a leading provider of information technology, consulting, and business process outsourcing services, dedicated to helping the world's leading companies build stronger businesses. Headquartered in Teaneck, New Jersey (U.S.), Cognizant combines a passion for client satisfaction, technology innovation, deep industry and business process expertise, and a global, collaborative workforce that embodies the future of work. With over 100 development and delivery centers worldwide and approximately 221,700 employees as of December 31, 2015, Cognizant is a member of the NASDAQ-100, the S&P 500, the Forbes Global 2000, and the Fortune 500 and is ranked among the top performing and fastest growing companies in the world. Visit us online at www.cognizant.com or follow us on Twitter: Cognizant.

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