Sr. Process Executive - PharmacoVigilence ICSR Case Processing

Posted 2 Days Ago
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Bengaluru North, Yelahanka, Bengaluru Urban, Karnataka, IND
In-Office
Senior level
Agency • Professional Services • Consulting
The Role
Process individual case safety reports end to end, including intake, triage, data entry, follow-up, coding, narrative writing, assessment, quality checks, reconciliation, and case closure. Ensure serious and non-serious cases meet regulatory timelines and maintain accurate documentation and compliance. Resolve discrepancies and support patient-safety processes while collaborating effectively across cultures and teams.
Summary Generated by Built In

About the Client:


Client is a global Fortune 500 IT solutions company specializing in delivering simple and scalable solutions to address complex business problems. More than 1,500 staff delivers technical and domain expertise across multiple platforms and industries to help enterprise companies drive productivity, efficiency and gain the most out of their technology investments.
Designation: Pharmacovigilance – Case Processing Associate 

Join our growing Pharmacovigilance team! We're looking for experienced professionals with expertise in ICSR Case Processing and Quality Review.

Open Positions
SPE – ICSR / Pharmacovigilance
Experience: 1–4 Years
Function: Pharmacovigilance / ICSR Case Processing

Key Responsibilities:


  • Manage end-to-end ICSR case processing, including intake, triage, data entry, follow-up and case closure.

  • Perform MedDRA/WHO Drug coding, narrative writing and case assessment as per SOPs and regulatory requirements.

  • Ensure accurate and timely processing/submission of serious and non-serious ICSRs within defined timelines.

  • Maintain high standards of data quality, compliance and documentation across the case lifecycle.

  • Support reconciliation, quality checks and resolution of case-related queries or discrepancies.


Required Skills:


  • 1–4 years of relevant Pharmacovigilance / Drug Safety / ICSR experience.

  • Hands-on experience in ICSR case processing.

  • Strong understanding of PV processes, regulatory timelines and safety case lifecycle.

  • Argus and/or Veeva Safety experience preferred.

  • Graduate/Postgraduate in Pharmacy, Life Sciences, Medical Sciences or a related discipline.



Requirements

  • Relevant educational background and experience in patient safety or related field
  • Strong presentation and communication skills
  • Effective intercultural work capabilities
  • Commitment to timely completion of tasks and documentation
  • Analytical and problem-solving skills
  • Collaboration and teamwork abilities


Joining Preference: Immediate to 30 Days highly preferred. 90-day notice period candidates will not be considered.



Skills Required

  • 1-4 years of relevant pharmacovigilance, drug safety, or ICSR experience
  • Hands-on experience in ICSR case processing
  • Strong understanding of pharmacovigilance processes, regulatory timelines, and the safety case lifecycle
  • Graduate or postgraduate degree in Pharmacy, Life Sciences, Medical Sciences, or a related discipline
  • Experience with Argus and/or Veeva Safety
  • Relevant educational background and experience in patient safety or a related field
  • Strong presentation and communication skills
  • Effective intercultural work capabilities
  • Commitment to timely completion of tasks and documentation
  • Analytical and problem-solving skills
  • Collaboration and teamwork abilities
  • Immediate to 30-day joining availability; candidates with 90-day notice periods will not be considered
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The Company
10,515 Employees
Year Founded: 1999

What We Do

2COMS is an India-based recruitment and manpower consultancy that helps organizations meet workforce needs through leadership hiring, general and IT staffing, apprenticeship management, international recruitment, gig workforce solutions, payroll and compliance, and HR technology. The company serves employers across industries while connecting job seekers with domestic and global opportunities through technology-enabled, end-to-end workforce and talent-management services.

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