Antibiotic Resistance (November 2015)

Opening with Grail Research(a Division of Integreon)- Pharma Research INTEGREON

About Grail Research
Grail Research (www.grailresearch.com) specializes in conducting strategic research including market, industry, and benchmark analyses for leading companies and investors across the globe. As part of Integreon (www.integreon.com), a leading global provider of KPO services, Grail Research offers an intellectually challenging and learning driven work environment designed around developing and delivering cutting edge research products.
Designation: Analyst Primary Responsibilities
Work with project teams and design analysis plan and most effective search strategies. Gather required information and filter relevant themes using a broad set of tools (e.g., subscription databases, the Internet, print media, company representatives, external research organizations, telephonic interviews with industry experts, etc). Utilize both secondary and primary (interview, survey) research sources and techniques
Organize, analyze, synthesize and/or summarize data and information using appropriate analytical tools. Conduct quantitative (e.g., statistical analysis, financial data analysis, etc.) and qualitative analysis (in-depth interviews, etc) as necessary
Communicate research results through the creation of structured end-products (memos, spreadsheets, reports, presentations, etc.)
Required Skills
0.6 to 3 years of relevant research experience
Strong analytical aptitude problem solving, quantitative
Strong verbal and oral communication skills
Team player and excellent interpersonal skills
Logical and creative thinker with enthusiasm and a desire to get involved at Grail Research

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Regulatory Support for Eu/us - OTC Or Cosmetics- iMEDGlobal

Responsibility

Specific day to day responsibility of the SMP support for EMEA position includes, but not limited to:
Ensure that standards and timelines are met
Use of regulatory data base (Register) and IT tools (GSS, Optiva, Starfish)
Create and update working practices for processes used between Outsource partner & EMEA Regulatory Affairs, using a lessons learned approach
Plan and track resource levels required and used for regulatory support requested.

Experience/Qualifications

Life Science or Chemistry or Pharmacist Degree or equivalent qualification.
Experience in European Regulatory Affairs for health products. Experience with Personal Care products would be desirable.
Demonstrate excellent communication skills both oral and written.
Analytical thought

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Quality Assurance - Pharmacovigilance-Crest

6,00,000 - 8,50,000 P.A
Job Description

• Communicate with Operations and clients to ensure compliance with Project Sops and Regulatory guidelines
• Prepare for regulatory as well as client audit
• Act as Compliance / safety lead for projects
• Prepare & conduct Internal Audits
• Implement and maintain effective Quality Assurance systems to ensure that local operations are in full compliance with Compliance standards and policies, GVP, GDP and regulatory requirements by performing the following
• Establish and manage Annual Quality Plans approved by relevant stake holders
• Corrective and Preventive Actions (CAPA) (including RCA and deviations)- Develop local processes based on global ones to conduct root cause analysis to investigate deviations and develop CAPAs. Demonstrate that the CAPA plans required are effectively implemented, monitored and closed out.
• Auditing Ensure a Local process is in place to support Audit activities as necessary, including Health Authorities Inspections. 
• Assist with self-inspections and ensuing corrective/preventive actions
• Manage quality alerts and regulatory intelligence.
• Manage Local Training activities as necessary. 
• Ensure the maintenance of the QMS through the appropriate impact assessment and QMS Management review processes.

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Pharma Data Entry Associate-Accenture

Organize, manage, and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity.

?Carry out all case management activities as appropriate.

?Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested

?Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios

?Ensure complete and timely forwarding of ICSR to Core

?Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed.

?Consistently apply regulatory requirements and Client policies

?Analyze and monitor activities, define and implement corrective actions, where applicable.

?Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database.

?Provide oversight and team mentoring on case handling aspects, data extraction, and analyses.

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