Job Description

Description:

 

Summary:

(optional)

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