Pharmacovigilance Services Analyst

3-5 years

Not Disclosed

Bangalore

10 Dec. 19, 2024

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 Analyst
Location: [Location not provided]

About Accenture:
Accenture is a global professional services company, renowned for its leadership in digital, cloud, and security services. We combine deep industry expertise and cutting-edge technology across over 40 industries, offering Strategy and Consulting, Technology and Operations services, and Accenture Song. With a workforce of 699,000 employees serving clients in more than 120 countries, we drive transformation through technology and human ingenuity. Visit us at www.accenture.com.

Job Overview:
As a Pharmacovigilance Services Analyst, you will work within Accenture's Life Sciences R&D division, supporting pharmacovigilance and drug safety surveillance activities for biopharma companies. Your responsibilities will include case processing, data entry, MedDRA coding, and submission of Individual Case Safety Reports (ICSRs) to ensure compliance with global regulatory requirements.

Key Responsibilities:

Manage and process cases for serious and non-serious reports, including creation, identification, data entry, and coding using MedDRA.
Perform follow-up actions and reconciliation of reports according to established processes.
Submit ICSRs to the safety database and relevant regulatory authorities as required.
Handle the Affiliate Mailbox and perform written follow-up attempts for both serious and non-serious cases.
Collaborate with peers within Accenture and receive detailed instructions for new assignments.
Ensure compliance with client guidelines, regulatory requirements, and internal procedures.
Perform quality checks on case documentation and submit data in a timely manner.
Interact with global case processing teams and address queries related to source documents and follow-up information.
Follow up with reporters for additional information and clarification when required.
Manage case intake, data verification, and submission processes.

Qualifications:

Education: Bachelor of Pharmacy or Master of Pharmacy.
Experience: 3 to 5 years in pharmacovigilance or drug safety.
Skills:
- Strong knowledge of pharmacovigilance processes, ICSR submission, and MedDRA coding.
- Good understanding of global regulatory requirements for pharmacovigilance.
- Strong written and verbal communication skills.
- Ability to work under pressure and meet deadlines.
- Detail-oriented with the ability to perform quality checks.
- Comfort in interacting with global teams and addressing inquiries.
- Ability to adapt to new assignments and work in a fast-paced environment.

What We Are Looking For:

Ability to analyze and solve lower-complexity problems.
Strong problem-solving skills and attention to detail.
Ability to perform in a collaborative environment with limited exposure to clients or management.
Comfort in working in rotational shifts.

Work Environment:

Rotational shifts may be required.

Apply Now:
For more information, visit Accenture Careers.

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