Job Description

Description:

Summary:

1 to 3 years of experience.
GURGAON location
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