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Job Description

Job Description

Description:

Summary:

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This position is a member of the Safety Operations team that handles country level PV activities including collection, documentation and processing of local adverse event (AE) reports from all sources.

Essential Duties and Responsibilities:

This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.

  • Manage collection, documentation and processing of local AE reports from all sources based on national legislations and in accordance with client's procedures . Perform surveillance activities for any new potential safety information and escalate per procedures . Perform local case triage including assessment of validity, duplicate check, and forwarding to internal and external partners as required. . Perform case intake within the Pharmacovigilance Safety System (PSS). . Respond to queries from the global case processing team. . Perform source document redaction as necessary and ensure all source documentation is captured in PSS. . Perform local quality checks as required. . Perform Health Authority case download where required . Other activities as required

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.

0 N/A: Intern or Co-op

  • Excellent attention to detail . Excellent oral and written communication . Operates effectively in a team environment . Ability to work under strict deadlines . Ability to multitask and prioritize changing workload . Medical and clinical knowledge . Ability to establish proficiency working within PSS

Education and/or Experience:

Include the education and/or experience that is necessary to perform the job satisfactorily.

0 N/A: Intern or Co-op

  • Degree in sciences, pharmacy or related field or minimum of 3 years pharmacovigilance experience

More Info

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About Company

Rangam India (Rangam Infotech Pvt. Ltd.), a subsidiary of US-based Rangam Consultants Inc., was incepted in 2005 as an information technology company in Vadodara, Gujarat. We have a branch office in Ahmedabad, Gujarat and satellite offices in Bengaluru, Karnataka and Kolkata, West Bengal. We provide staff augmentation, customized software development and educational services to clients in India.

Job ID: 144555055

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