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SME-Pharmacovigilance

SME-Pharmacovigilance

Cognizant

3 years

0 Lacs

Mumbai, Maharashtra

Posted:4 days ago| Platform: SimplyHired logo

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Skills Required

Microsoft Powerpoint Microsoft Office Master's degree Bachelor's degree Medical terminology Time management

Work Mode

On-site

Job Type

Full Time

Job Description

Job Summary

The SME-Pharmacovigilance role is crucial for ensuring the safety and efficacy of pharmaceutical products. The candidate will leverage their expertise in PV Case Processing and customer service to enhance pharmacovigilance operations. This position requires a proactive approach to monitoring drug safety and contributing to research and development efforts.

Responsibilities

Triage & intake of ICSRs in ARGUS databases within agreed timelines

Download and monitor valid ICSRs from Eudra Vigilance (EV)- or any other sources

Process literature, spontaneous, clinical trial, and solicited cases

Search for valid ICSRs in Literature search tools

Generate reports and submit to health authorities and business partners

Enter serious and non-serious ICSRs in ARGUS per client SOP and WI with high accuracy

Code events, indications, patient history using MedDRA

Code suspect products, amend narratives, and label events

Obtain follow-up information for all cases per applicable guidelines

Submit processed cases to regulatory authorities and distribute reports to Partners

Communicate effectively with client stakeholders and internal teams

Attend all internal and client trainings to ensure guideline compliance

Ensure adherence to regulatory requirements and industry standards in all aspects of pharmacovigilance and safety operations.

Assist in the development and maintenance of standard operating procedures to ensure consistency and quality in process execution.

Support training and development initiatives to enhance team capabilities and knowledge in pharmacovigilance and safety operations.

Utilize technical skills to troubleshoot and resolve process-related issues, minimizing disruptions and ensuring smooth operations.

Engage in rotational shifts to provide consistent support and coverage across different time zones.

Requirements

Bachelor’s / Master’s degree in pharmacy.

Minimum 3 years relevant work experience in case processing activities.

Experience in Cardiovascular (CVS), Neuroscience (CNS), Oncology, Immunology therapeutic areas and Gene Therapy will be an added advantage. Experience with global pharma sponsor will be preferred.

In-depth knowledge and understanding of applicable global, regional, and local regulatory requirements, including Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Conference of Harmonization (ICH) guidelines, SOPs.

Excellent organizational and time management skills.

Proficiency in Microsoft Office and web-based applications (e.g., Word, Excel, PowerPoint).

Good knowledge of medical terminology.

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Cognizant

IT Services and IT Consulting

Teaneck New Jersey

10001 Employees

3000 Jobs

Key People

Brian Humphries

CEO
Gina Schaefer

CFO
Ranjan Kalia

President, Cognizant North America
Katherine H. (Katie) Talarico

Chief Marketing Officer

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SME-Pharmacovigilance