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Pharmacovigilance Services Specialist

7-11 years
Not Disclosed
10 Feb. 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Pharmacovigilance Services Specialist

Location: Bengaluru, India

Job Type: Full-time

Experience Required: 7–11 years

Education: Bachelor’s or Master’s in Pharmacy (B.Pharm / M.Pharm)


Company Overview

Accenture is a global leader in digital, cloud, security, strategy, and consulting services, serving clients in over 120 countries. The Life Sciences R&D vertical focuses on pharmaceutical, biotechnology, and healthcare industries, covering areas such as clinical trials, regulatory compliance, pharmacovigilance, and patient services.


Role Overview

As a Pharmacovigilance Services Specialist, you will be responsible for:

  • Case processing of Individual Case Safety Reports (ICSRs), including data entry, MedDRA coding, submission, and follow-ups.
  • Managing affiliate mailbox reconciliation and tracking reports.
  • Conducting serious and non-serious adverse event (AE) follow-ups as per global regulatory guidelines.
  • Ensuring compliance with client SOPs and pharmacovigilance regulations.
  • Interacting with clients and internal teams to ensure seamless drug safety operations.
  • Problem-solving and process improvement for complex pharmacovigilance issues.

Key Responsibilities

 Case Management & Reporting:

  • Process ICSRs in the safety database as per global regulatory requirements.

  • Perform MedDRA coding, narrative writing, and case assessment.

  • Ensure timely reporting of safety cases to regulatory authorities.

Stakeholder Communication & Compliance:

  • Liaise with cross-functional teams and clients for case management and compliance.

  • Maintain pharmacovigilance documentation and records.

  • Ensure compliance with Good Pharmacovigilance Practices (GVP) and company policies.

 Process Optimization & Leadership:

  • Identify opportunities for process improvements in pharmacovigilance operations.

  • Manage small teams or work independently, depending on project requirements.

  • Support training initiatives for junior pharmacovigilance professionals.


Qualifications & Skills

Education:

🎓 Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm) is required.

Experience:

  • 7–11 years of experience in pharmacovigilance operations (case processing, safety surveillance, MedDRA coding).
  • Experience with pharmacovigilance databases (Argus, ArisG, etc.).
  • Knowledge of global PV regulations (FDA, EMA, MHRA, ICH-GCP).

Key Skills:

Strong analytical and problem-solving skills for handling complex pharmacovigilance issues.
Attention to detail in case processing and reporting.
Good communication and stakeholder management for working with clients and teams.
Ability to lead small teams and drive process improvements.
Willingness to work in rotational shifts (if required).


Why Join Accenture?

Work with leading biopharma companies in cutting-edge pharmacovigilance projects.
Global exposure in an internationally recognized company.
Career growth opportunities in life sciences and drug safety.
Flexible & collaborative work culture.


Interested candidates can apply at Accenture Careers.