Pharmacovigilance Services Analyst

3-5 years

Not Disclosed

Bangalore

15 June 6, 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, 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 Description

Position: Pharmacovigilance Services Analyst

Skill Required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance

Qualifications: Any Graduation

Years of Experience: 3 to 5 years

About Accenture:

Accenture is a global professional services company with leading capabilities in digital, cloud, and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song—all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners, and communities. Visit us at www.accenture.com.

Job Role and Responsibilities:

What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision

to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.

Key Responsibilities:

Management of Affiliate Mailbox: Reconcile reports as per process and perform all written follow-up attempts, including both Serious and Non-serious cases.
Case Management: Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements.
PSUR Preparation and Review:
- Prepare and review PSURs as per Client SOPs and Work Instructions.
- Identify contributors based on the contact list and liaise with the Client Drug Regulatory Affairs team for necessary inputs.
- Coordinate data cleaning processes prior to final listings generation.
- Act as lead author to prepare submission-ready draft reports and perform peer reviews.
- Facilitate stakeholder reviews including QC & QPPV reviews and address comments from all stakeholders.
- Ensure consistency in formatting before submission and timely escalation of delayed inputs.
- Archive all PSUR related information in dedicated folders on shared drives and update the PSUR tracker.

What are we looking for?

Educational Requirement:

B.Pharm / M.Pharm / PhD / BDS / BHMS / BAMS / Masters in Life Sciences.

Work Experience Requirement:

4 to 5 years of experience in drug safety, development, or closely related areas, or 2 years of experience in medical writing or working on aggregate reports.

About Accenture:

Equal Opportunity Employment: Accenture is committed to creating an inclusive and diverse work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We encourage all to apply.

For more information on how we collect and store your personal data, please see our Privacy Statement.

Interested in the role but unsure if you meet all the requirements? We encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at Accenture, whether it is for this or other roles.

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