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Monday, July 11, 2011

Team Lead-Parmacovigilance 6 Opening(s)

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2 - 6 Years
Rupees 4,50,000 - 7,00,000
UG - B.Pharma - Pharmacy,BDS - DentistryPG - Any PG Course - Any Specialization,Post Graduation Not Required
Industry Type:
KPO / Research /Analytics
Bio-Tech Research Associate/Scientist
Functional Area:
Healthcare, Medical, R&D
Posted Date:
10 Jul

Desired Candidate Profile

• Bachelor’s Degree in Pharma/ Life Science or equivalent in a related discipline;

• More than 3 years’ of experience in Pharmacovigilance /Pharmaceutical / Clinical research professional.

Job Description

As Case Intake Member:

• Responsible for Case intake, duplicate check and registration

• Maintain log of source documents, and other communications

As Case Processor:

• Responsible for Data entry of single cases into Safety Database Application.

• Review and evaluate AE case information to determine required action based on and following internal policies and procedures

• Process current incoming cases in order to meet timelines

• Full Data entry including Medical coding and Safety Narrative
As Medical Coder:

• Responsible for coding of all medical events, drugs /procedures/implements according to

the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)
As Narrative writer:

• Responsible for writing medically relevant Safety narrative of cases and checking the completeness and accuracy of the medical data entered in the various fields.

As QC Reviewer:

• Review data entered in safety database
Other responsibilities:

• Process current incoming cases in order to meet timelines

• Following up with sites regarding outstanding queries and reconciliation of discrepancies

• Closure and deletion of cases

• Follow departmental AE workflow procedures

• Oversee, mentor and guide the activities of the Drug Safety and Senior Drug Safety Associates

• High level of proficiency at all workflow tasks

• Perform any other drug safety related activities as assigned

• Willingness to work in 24*7.

• Develop reports in Business objects.

• Work with cross-functional divisions including Customer Support, Professional Services.

• Subject Matter Expertise in ARISg, agXchange or agInquirer.

• Proven experience in customer handling and relationship.

• Proven ability to perform task management.

• Proven People management skills.

• Must have good presentation skills and the ability to give presentations.

• Knowledge of the Life Sciences Industry a plus.

• Experience in entire software development life cycle.

• Relevant product and industry knowledge

• Experience with relevant software applications

Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross-department communication. Ability to document and communicate problem/resolution and information/action plans.

• Person should be familiar with MS Office tools/Data base Application.

• Ability to educate/ train the team members as needed.

• Contributing to the ongoing enhancement of Pharmacovigilance process and SOP’s including internal and external training.

• Maintaining Pharmacovigilance systems including global safety database.

The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrated flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and


Keywords: Case Processor, Medical Coder, Narrative writer, QC Reviewer,

Company Profile

Synowledge specializes in providing drug safety and pharmacovigilance services to small, mid and large size pharmaceutical and biotechnology companies. Our team consists of highly qualified and skilled experts (MDs, PhDs and other individuals with Life Science backgrounds and PV experience) who are committed to helping life sciences companies meet and exceed their challenging demands of a critical component of safety reporting. Synowledge’s broad range of solutions include call center (includes handling of medical inquires and product complaints and processing of medical inquiry calls), case intake and data entry, coding, expert medical triaging of adverse event cases, generation of expedited and periodic reports, Qualified Person for Pharmacovigilance (QPPV) services and overall analysis and trending of cases (signal detection).
Contact Details
Company Name:
Synowledge PV Services India Pvt Ltd
Executive Name:
Jayasudha Puttaswamy
Not Mentioned


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