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Pharmacovigilance Services Analyst

3-5 years
Not Disclosed
15 June 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, 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

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance


Designation: Pharmacovigilance Services Analyst


Qualifications:Bachelor of Pharmacy/Master of Pharmacy/Master Of Physiotherapy


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


What would you do? The Pharmacovigilance BookIn Associate is responsible for the initial intake, data entry and classification of adverse event reports received by the Safety department from various sources. This role ensures timely and accurate booking of cases for subsequent processing and analysis.


What are we looking for? - Bachelor’s degree in Life Sciences, Healthcare or related field - 1-2 years related pharmacovigilance experience is preferred - Proficiency with drug safety database applications and automation tools - Working knowledge of global pharmacovigilance processes and regulations - Meticulous attention to detail with emphasis on quality and compliance - Strong communication, collaboration and follow up abilities - Ability to handle repetitive tasks with high accuracy under tight timelines


Roles and Responsibilities: - Log and enter adverse event reports into the drug safety database - Review reports for completeness, accuracy, and applicability of reporting rules - Identify and validate all necessary reportable data elements for appropriate case processing - Assign company product names to adverse event reports - Categorize event by type (medication error, lack of effect, etc.) and seriousness classification - Determine report sources and reporting obligations per licensing commitments - Route booked cases to appropriate safety groups for full case data entry and narrative writing - Follow up internally for missing information or with reporters for incomplete data - Maintain timely booking metrics and performance indicators