Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance
Designation: Pharmacovigilance Services New Associate
Qualifications:Bachelor of Pharmacy/BSc. Nursing/Bachelor Degree in Life Sciences
Years of Experience:0 to 1 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? Responsible for identification and creation of cases in the Global safety database from the reports received via intake workflow, client mailbox, electronic gateway, and other sources (as applicable). Responsible for retrieving new incoming safety information or follow-up correspondence for existing cases in compliance with client standard operating procedures (SOP) and global regulatory requirements. Responsible for triage, case prioritization, data entry, case processing, submission and follow up (as applicable) of serious and non-serious cases in the core safety database as per Client guidelines and global regulatory requirements.
What are we looking for? Educational and Experience Requirements: • Bachelor’s Degree in Life Sciences • Technology skills: experience with MS office, knowledge of safety database • Good knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug preferred. • Good medical writing skills • Good Communication Skills • Strong English Language proficiency (Reading, Writing, Listening and Speaking). Key performance indicators: • Ability to learn quickly. • Consistent demonstration of company values/behaviors. • Adverse events are evaluated accurately, and cases are processed within the required timeframes to meet regulatory requirements. • Process cases with good quality metrics. • Performs all work in accordance with all established regulatory and compliance and safety requirements. • Assisting with tracking, submitting and distributing of reports; assisting liaisons with the partners and cross-functional team members to ensure compliance; supporting various ad-hoc deliverables or pharmacovigilance projects; and participating in audits and inspections. • Validate data consistency and make any corrections as needed. • Determine if any additional information is needed for clarification, or if any follow-up is necessary, and take all relevant steps to obtain any additional/missing information as stated in the relevant Client SOP. • Check for any pending action items, follow-up, clarification, corrections and ensures resolution and close the action items for the case. • Perform submissions in global safety database for all the AEs, SAEs and SUSAR cases as per Client SOP, to Monitor submission related client reports and trouble shoot submission issues if any. • Perform translations of source document, case narrative, adverse events as applicable. • Monitoring, tracking and reconciliation of client mailboxes and other sources as applicable. • To perform paper and electronic unblinding process if required as per Client SOP
Roles and Responsibilities: • Prioritise, book in, triage, and case processing activities for ICSRs in accordance with Client Guidelines, Regulatory due date, and TAT SLAs and KPIs. The case processing activity includes end to end case processing as per the agreed client requirement and case processing guidelines. • Prioritize the cases from Intake workflow, mails and other sources to create cases in global safety database, identify, review for validity of cases and move the cases to respective workflow step based on case type as per the defined timelines. • To perform collection, evaluation, and submission of Adverse Event (AE) reports, transmission, and reconciliation of pharmacovigilance data of individual case reports. This includes but is not limited TMF (Trial Master File) review download of AE reports from EVWEB and the MHRA portal and the importing of AE reports on the pharmacovigilance database. • Review the source documents (SD) for validity of ICSR, perform duplicate check in the intake workflow/safety database and confirm whether the information is medically significant or relevant and takes necessary actions in accordance with Client SOPs. • Request for missing minimum safety Information or clarification of erroneous data if needed and sent queries in accordance with Client SOP, guidelines from the Marketing company (MC) or reporter as applicable. • Complete the case processing of safety information, including but not limited to coding of relevant medical history, suspect drug, adverse event and draft narrative into the applicable Global Safety Database from the available source documents. • Assess adverse events for seriousness, causality as per applicable Client SOPs, consulting the medical reviewer or medical validator whenever needed. • Perform medical coding/Drug Coding for each ICSR in accordance with Client Guidelines and SOPs using MedDRA and WHODD. • Complete and review the evaluation of the case including reporter/company causality, prepare the narrative section and E2B sender’s comment field as per Client SOP. • Processing all the AEs, SAEs and SUSARs in the Global Safety Database according to the applicable company policies and Standard Operating Procedures (SOPs). • Other essential duties include drafting pharmacovigilance agendas and meeting minutes; accurately archiving pharmacovigilance documents; reviewing safety case data and other pharmacovigilance documents for completeness and accuracy.

Bachelor of Pharmacy,BSc. Nursing,Bachelor Degree in Life Sciences

About Accenture

Accenture is a leading global professional services company that helps the world’s leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services—creating tangible value at speed and scale. We are a talent- and innovation-led company with approximately 791,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world’s leaders in helping drive that change, with strong ecosystem relationships. We combine our strength in technology and leadership in cloud, data and AI with unmatched industry experience, functional expertise and global delivery capability. Our broad range of services, solutions and assets across Strategy & Consulting, Technology, Operations, Industry X and Song, together with our culture of shared success and commitment to creating 360° value, enable us to help our clients reinvent and build trusted, lasting relationships. We measure our success by the 360° value we create for our clients, each other, our shareholders, partners and communities.

Visit us at www.accenture.com 

Equal Employment Opportunity Statement

We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, military veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by applicable law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.