• GPV Jobs in United States Of America

  • Boehringer Ingelheim India Pvt Ltd
  • United States Of America, Usa
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  • 3 - 5 Years
  • Posted : above 1 month

Job Description:

GPV (Pharmacovigilance) Data Retrieval Manager I - Ridgefield, CT location - 198663

GPV (Pharmacovigilance) Data Retrieval Manager I - Ridgefield, CT location

Description

The Pharmacovigilance (PV) Data Retrieval Manager is responsible for the generation of line listings and other reports for official and internal/external use, in line with global procedures and in support of global regulations This includes manually generated listings attached to official reports (eg PBRER, DSUR), the maintenance of scheduled reports sent at regular intervals to various recipients, and the creation of ad hoc reports with supervision

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies success We realize that our strength and competitive advantage lie with our people We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance Our competitive compensation and benefit programs reflect Boehringer Ingelheims high regard for our employees

Duties & Responsibilities

Timely and accurate generation and distribution of listings submitted to both internal and external recipients Maintenance of auto-distributed reports and line listings Tracking of requests in DOORS (Dynamic Object Oriented Requirements Management System)
Follow guidance in relevant manuals and working instructions which accurately describe the data retrieval tasks
RRT contact for Global Case Management, clinical teams, global CSOs, and other key stakeholders regarding the data retrieval process, in order to provide data which fulfills the requestors need
Participate in the ongoing maintenance and enhancement of existing reports, based on requirements of the business Provide training on new or updated reports to impacted teams
Liaise with Business Support and IS department regarding the technical aspects of the various systems, with a focus on meeting expectations of the business unit and compliance with global regulations
Identify business critical issues and escalate as applicable
Ensure compliance with information protection guideline, privacy requirements and Data Retrieval SOP in order to provide requested data in accordance with Company policies and global regulations
Participation in local and/or international project groups Complete special projects as assigned

Requirements

Bachelors degree or higher in computer science or related health care field
Minimum of one (1) to three (3) years pharmaceutical industry experience with one (1) year experience in pharmacovigilance (preferred)
Technical skills to include a strong working knowledge of relational databases (preferably Oracle), SQL, and report writing/query extraction tools such as, Oracle Forms/Reports or SAS
Working knowledge of FDA regulations (preferred)
Ability to make decisions independently
Ability to prioritize workload and perform under stress in situations in which working speed and sustained attention are critical aspects of the job
Must be able to communicate and resolve issues effectively with inter/intra departments through strong interpersonal skills
Proficient in electronic data capture tools (ie ARISg), clinical databases (ie CTMS/CTMF), and Microsoft-based applications (ie, Word, Excel, Powerpoint)
Must have problem solving skills and the ability to organize time effectively
The PV Data Retrieval Manager (DRM) ensures that reports and line listings are distributed in accordance with global and local SOPs/Working instructions and local regulations Failure to accurately assess cases for regulatory reporting could put the company at risk for non-compliance with federal regulations The DRMs knowledge of the business must remain current to adequately evaluate the impact of process changes on data retrieval tools and outputs, and to provide accurate, reliable, and meaningful data to meet the intended business need

Eligibility Requirements

Must be legally authorized to work in the United States without restriction
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older

Our Culture

Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view Our focus is on scientific discoveries that improve patients lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the worlds 20 leading pharmaceutical corporations At Boehringer Ingelheim, we are committed to delivering value through innovation Employees are challenged to take initiative and achieve outstanding results Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc, Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc, Roxane Laboratories Inc, Boehringer Ingelheim Vetmedica Inc and Boehringer Ingelheim Fremont, Inc is an equal opportunity employer Minority/Female/Protected Veteran/Person with a Disability

Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings

Job - Pharmacovigilance

Primary Location - Americas-US-CT-Ridgefield

Organization - US-BI Pharma/BI USA

Schedule - Full-time

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : IT Software : Software Products & Services
Role : Software Engineer
Salary : As per Industry Standards
Deadline : 11th Jan 2020

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