Job Title: Pharmacovigilance Services New Associate
Job ID: AIOC-S01621732
Employment Type: Full-Time
Experience Required: 0–2 Years
Location: Bengaluru, India
Function: Pharmacovigilance Operations / Drug Safety
Industry: Clinical Research & Pharmacovigilance
Job Overview
We are seeking a Pharmacovigilance Services New Associate to join a global pharmacovigilance operations team. This entry-level role is ideal for life sciences graduates who are looking to build a career in drug safety, adverse event case processing, and global pharmacovigilance compliance.
The role focuses on individual case safety report (ICSR) intake, triage, case processing, data quality checks, and regulatory submissions, ensuring compliance with client SOPs and international regulatory requirements.
About the Organization
Accenture is a leading global professional services organization with capabilities across digital, cloud, security, technology, and operations. With a workforce of over 784,000 professionals serving clients in more than 120 countries, Accenture supports innovation and operational excellence across multiple industries, including life sciences and healthcare.
Key Responsibilities
Case Intake & Processing
Identify, triage, and create safety cases in the global safety database from multiple intake sources such as workflows, client mailboxes, electronic gateways, and partner systems.
Perform end-to-end ICSR processing for serious and non-serious cases in line with client guidelines, regulatory timelines, and quality standards.
Retrieve and process follow-up safety information in compliance with SOPs and global regulatory requirements.
Pharmacovigilance Operations
Perform accurate data entry, validation, reconciliation, and case corrections within defined timelines.
Conduct duplicate checks, validity assessments, and minimum safety information evaluations.
Code adverse events, medical history, and suspect drugs using MedDRA and WHO-Drug dictionaries.
Draft and review case narratives, E2B sender comments, and supporting documentation.
Regulatory Compliance & Submissions
Support the submission of AEs, SAEs, and SUSARs through the global safety database as per regulatory and client SOPs.
Monitor submission status, troubleshoot submission issues, and ensure compliance with global timelines.
Assist with translations of source documents, narratives, and adverse event information as applicable.
Quality, Audits & Process Support
Ensure high-quality case processing aligned with regulatory, compliance, and safety requirements.
Support audits, inspections, and transition-related activities as per client needs.
Track, distribute, and archive pharmacovigilance documents and communications within the safety database.
Participate in ad-hoc pharmacovigilance projects and cross-functional initiatives.
Performance Expectations
Accurate evaluation and timely processing of adverse events in accordance with regulatory timelines.
Consistent achievement of quality metrics and SLAs.
Ability to learn quickly and adapt to changing business requirements.
Successful completion of all mandatory pharmacovigilance and compliance training.
Education & Experience
Educational Qualifications:
Bachelor’s degree in Life Sciences, BAMS, BSc Nursing, or related healthcare disciplines.
Experience:
0–2 years of experience in pharmacovigilance, drug safety, clinical research, or a related field.
Freshers with relevant academic exposure or internships in pharmacovigilance are encouraged to apply.
Required Skills & Competencies
Basic knowledge of pharmacovigilance and drug safety processes.
Familiarity with medical terminology and safety dictionaries (MedDRA, WHO-Drug preferred).
Proficiency in MS Office; exposure to safety databases is an advantage.
Strong written and verbal English communication skills.
Good medical writing and documentation abilities.
High attention to detail, analytical thinking, and ability to follow SOP-driven processes.
Willingness to undergo training and transition across roles based on business needs.
Why Join This Role
Entry-level opportunity to build a long-term career in pharmacovigilance and drug safety.
Exposure to global safety databases, regulatory frameworks, and international clients.
Structured training and learning environment within a large global organization.
Opportunity to work on real-world safety cases impacting patient safety worldwide.
Apply Now
If you are a life sciences graduate looking to start your career in pharmacovigilance, clinical safety, and drug safety operations, apply now through thepharmadaily.com and take your first step into global healthcare research.
SEO & GEO Keywords:
Pharmacovigilance Jobs Bengaluru, Entry Level Pharmacovigilance Jobs India, Drug Safety Associate Jobs, ICSR Processing Jobs India, Fresher Pharmacovigilance Roles, Global Pharmacovigilance Careers, Clinical Safety Jobs India
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