Performs day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and performs Pharmacovigilance activities such as data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors. May assist in the preparation of departmental and project-specificprocedures and processes, prepare for and attend audits, kick-off and investigator meetings.
Essential Functions :
Performs day-to-day PV activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.
Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states.
Reviews cases entered for quality, consistency and accuracy, including review of peer reports.
Prepares and maintains regulatory safety reports.
Assists with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. Mentors less experienced staff
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Knowledge, Skills and Abilities:
Min 4+ Years of expereince in PV case processing
Should have worked in Clinical Trial and PMS cases
Should have working expereince in Argus Database
General understanding of pathophysiology and the disease process
Detailed knowledge of relevant therapeutic areas as required for processing AEs
Strong critical thinking and problem solving skills
Good oral and written communication skills including paraphrasing skills
Good command of English and ability to translate information into local language where required
Computer literate with the ability to work within multiple databases
Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)
Understanding the importance of and compliance with procedural documents and regulations
Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
Strong attention to detail
Ability to maintain a positive and professional demeanor in challenging circumstances
* Ability to work effectively within a team to attain a shared goal
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Job Detail
Job Id
JD3796418
Industry
Not mentioned
Total Positions
1
Job Type:
Full Time
Salary:
Not mentioned
Employment Status
Permanent
Job Location
Remote, IN, India
Education
Not mentioned
Experience
Year
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MNCJobsIndia.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.