Home
Jobs
Companies
Resume
Outpace Consulting Services logo

Life Science : Aggregate Safety Report : Max 15 LPA : Apply

6 - 11 years

10 - 15 Lacs

Pune Mumbai (All Areas)

Posted:2 weeks ago| Platform: Naukri logo

Apply

Skills Required

Safety Report Syneos Pfizer Aggregate Reporting Novo Nordisk PSUR PV Clinical Veeva Vault PBRER Clinical Trials Clinical Research Drug Safety Fortrea SUSAR ICON Cognizant Argus Safety Accenture MedDRA Pharmacovigilance IQVIA Novartis Parexel Aggregate Life Science

Work Mode

Work from Office

Job Type

Full Time

Job Description

Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55

More Jobs at Outpace Consulting Services

Customer Service Associate : Voice Support : Grads/UG : Apply Now

Chennai

Experience: Not specified

|

INR 2 - 4 Lacs

Sr Associate : International Voice : Grads : Apply Now

Chennai

Experience: Not specified

|

INR 2 - 4 Lacs

BPO : International Voice : Chennai : Grads : 5 Days Work : Apply Now

Chennai

Experience: Not specified

|

INR 2 - 4 Lacs

Customer Focus : Voice Process : Chennai : Grads : UG : Apply

Chennai

1 - 5 yrs
|

INR 2 - 4 Lacs

HR Intern : Recruitments : Females : Freshers : Apply Now

Allahabad

Experience: Not specified

|

Salary: Not disclosed

Mock Interview

Practice Video Interview with JobPe AI

Start Safety Report Interview Now

My Connections Outpace Consulting Services

Download Chrome Extension (See your connection in the Outpace Consulting Services )

chrome image
Download Now
Outpace Consulting Services
Outpace Consulting Services
www.outpaceconsulting.com

Consulting

Tech City

50-100 Employees

1425 Jobs

    Key People

  • John Doe

    CEO

  • Jane Smith

    COO

RecommendedJobs for You

Outpace Consulting Services logo

Life Science : Aggregate Safety Report : Max 15 LPA : Apply

Outpace Consulting Services

Pune, Mumbai (All Areas)

Outpace Consulting Services logo

Life Science : Aggregate Safety Report : Max 15 LPA : Apply

Outpace Consulting Services

Pune, Mumbai (All Areas)

Firstsource logo

Medical Coder - Team Leader

Firstsource

Chennai

CIEL HR logo

BIM Engineer

CIEL HR

Hyderabad

1mg logo

Senior Pharmacist

1mg

Jaipur

Chennai Fertility Center And Research Institute logo

Urgent Requirement - Pharmacist - Location - Hyderabad

Chennai Fertility Center And Research Institute

Hyderabad

Access Healthcare logo

Walk-in drive For Medical coding freshers

Access Healthcare

Chennai

CorroHealth logo

Hiring For Medical Coding Freshers!!

CorroHealth

Bengaluru

Avontix logo

Data Integration Engineer

Avontix

Hyderabad

Access Healthcare logo

Hiring Experienced Medical Coders WFH/WFO - Chennai,Coimbatore,Mumbai.

Access Healthcare

Pune, Chennai, Coimbatore