Thursday, 3 December 2015

Walkin Drive on 12th Dec 2015 for Clinical Data Management in Mumbai

Quintiles Careers
Dear Candidates,

Greetings from Quintiles!!!

We are having a Walkin drive  for CDM and have multiple position open in Mumbai on 12th DEC 2015 venue would be shared shortly. Please share your CV to bincy.mathew@quintiles.com

Job location:Mumbai

Job Title : Clinical Data Coordinator/Sr. Clinical Data Coordinator/Data Team Lead

RESPONSIBILITIES
Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or a
leadership role in a specific area or process on a large study with guidance.
Serve in the role of back-up to a Data Operations Coordinator or Data Team Lead.
Conduct data review.
Write and resolve data clarifications.
Lead database audit team.
Develop and test databases and edit specifications.
Understand and comply with core operating procedures and working instructions.
Meet objectives as assigned.
Develop and maintain good communications and working relationships with CDM team.
All responsibilities are essential job functions unless noted as nonessential (N).
Exp::RAVE,Oracle,OCR-DC etc.
Note: Kindly ignore if irrelevant.


Recruiter Name:HR
Address:Quintiles,Etamin Block, Wing B, I floorPrestige Tech Park II, Outer Ring RoadSarjapur, Bangalore - 560103BANGALORE,Karnataka,India 560103

Drug Safety Division (regulatory Affairs)


  • Review of task and allocation of assignments to team members
  • Analyse performance of team members periodically to ensure compliance with organizational SOP, regulatory guidelines and quality metrics
  • Identify training needs for the new employee/ team members to ensure quality and accuracy in activities handled
  • Co-ordinate with legal department for signing CDA, MSA and SOW with the vendor
  • Monitor performance of vendor as per SOW, KPI s and SOPs
  • Attend weekly calls with vendors and ensure timely escalation of outstanding issues
  • Perform periodic/ as- hoc audit of the vendors
  • Assist in the development of departmental SOP's and work instructions
  • Review of PADERs, PBRERs and PSURs
  • Involvement in signal detection activities and in DSRC meetings
  • Configure product, study, formulation in Argus database as per requirement
  • Perform periodic and frequent review of Argus database as per requirement
  • Perform periodic and frequent review of Argus database to determine status of reportable cases by generating of line listing as per SOP
  • Assign PADERs to the team members at the start of the month
  • Through knowledge of Pharmacovogilance activities
APPLY ONLINE

Drug Safety Associate

Synowledge PV Services India Pvt Ltd Careers
We are expanding! Hiring Drug Safety Associates to be based @ our GDC in Mysore.

Position: Drug Safety Associate

Work Location : Mysore

Experience : 0 to 1 year

Shifts : Flexible to work in shifts (including night shifts)

Educational Qualification :

Any HCP ( BPharma / MPharma / Pharm D / BDS / MDS / BAMS / BHMS / BPT / MPT / BSc Nursing)

Non HCP Post Graduates in Microbiology, Bioinformatics, Clinical Research, Biophysics, Molecular Biology, Medicinal Chemistry, Nuclear Sciences, Biochemistry, Biotechnology

Role & Responsibilities

Case Processing
Medical Coding
Narrative Writing

Walk In Date : Saturday, 5th December 2015

Walk In Time : 10:00 AM

Venue:
Synowledge Bangalore
#120/A, Elephant rock road,
Jayanagar 3rd Block,
Bangalore -560 011. India

APPLY ONLINE

NH- Pharmacovigilance


PURPOSE OF THE JOB

The position manages a group of highly experienced DSU, Case Processing and Medical Review team in the PV project. The profile is the primary interface with the client team.

MAIN ACCOUNTABILITIES

Accountable for performance, consistency, and quality of the deliverables.

Ensure team members are trained and mentored appropriately.

Ensure the completeness and validity of cases submitted to the client.

Ensure product delivery to client timeline and quality expectations.

Resolve data issues with the Client Team.

Balance workload within a team of DSU, CP & MR programmers and ensure timelines are met.

Implement measures to ensure corrective actions are taken.

Resolve any issues identified by the team.

Accountable for providing updates to the team any changes in the way in which work is performed. Ensure efficiency of operations.

Update the employee ware house
hosting the individual productivity and employee leave details within the defined time frames.

Provide feedback to QC roles for quality and efficiency improvement and ensure necessary corrective measures are taken.

Production ready assessment support new employees in their Production work.

Organize mentoring for new employees as and when required.

Recruit and hire the right skills

Identify opportunities for continual improvement.

Implement best practices for quality deliverable to client.

People management and mentoring team members to ramp up and deliver as per client requirements.

Ensuring customer satisfaction on project deliverables.

Ability to manage a team size of over 80