Job Description

Overall Purpose of the Job

Performs quality control of data processing in the safety database for received source documents of cases collected during safety monitoring of drugs and compounds, which includes triage, data entry, coding and narrative writing of individual case safety reports. Within agreed timeframes and to a high standard of accuracy, in compliance with Customer business rules, standard operating procedures and global regulatory requirements as documented in Customer’s SOPs
Ensures integrity and consistency of data against source document by performing QC and appropriate correction of all processed cases in appropriate timelines as per standard operation procedures.
Drives quality improvement by identifying individual quality defects, analysing trends and providing feedback to case processing associates.


Professional Background
Quality Control Associate with a minimum of 1-2 years of PV ICSR case processing experience. Experience with peer QC of ICSR cases.
Good understanding of drug safety, Individual Case Safety Reports and global regulatory requirements.
Good knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug Dictionary.
Hands-on experience of working on a Safety database.
A life science professional by qualification.

Key Expertise and Skills
Strong Communication skills in English
ICSR Case intake, processing and QC
Attention to detail
Analytical ability
Ability to work independently under tight time constraints.
Team worker
Training and presentation skills



Qualifications

Selected Relevant Experience

Pharmacovigilance experience with ICSR case processing experience of 1-2 years. Experience performing peer QC as per the defined Client SOPs, scorecard and requirements on ICSR data within the Client’s Safety database. Experienced in handling CAPA and deviation. 
Good understanding of the applicable PV regulations and guidelines specifically GVP Module VI and FDA 314.80 and 314.98
Responsible for performing Quality Checks for cases entered in the Argus Safety database in ordinance with the applicable SOP.
Responsible for performing Quality checks with reference to the agreed quality parameters and documenting the QC results in the checklist/scorecard.
Performing the corrections in the case and communicating the findings to the case processor.
Experience of collaborating with managers to implement process improvements and track and escalate issues or team’s training needs. 
Support the team during audits and inspections

All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.

Accenture is committed to providing veteran employment opportunities to our service men and women.

APPLY NOW
To apply from a mobile device, your CV must be in the cloud. Not Ready? Send this job to an email address To apply from a tablet device, your CV must be in the cloud. Not Ready? Send this job to an email address

Life at Accenture

Work where you're inspired to explore your passions and where your talents are nurtured and cultivated. Innovate with leading-edge technologies on some of the coolest projects you can imagine.

image

Training and Development

Take time away to learn and learn all the time in our regional learning hubs, connected classrooms, online courses and learning boards.

LEARN MORE

image

Work Environment

Be your best every day in a work environment that helps drive innovation in everything you do.


LEARN MORE

View All

Learn more about Accenture

Our more than 500,000 people in more than 120 countries, combine unmatched experience and specialized skills across more than 40 industries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.

View All

Stay connected

Join our Team

Join Our Team

Search open positions that match your skills and interest. We look for passionate, curious, creative and solution-driven team players.

Keep up to date

Keep Up to Date

Stay ahead with careers tips, insider perspectives, and industry-leading insights you can put to use today–all from the people who work here.

Stay Connected

Stay Connected

Receive job alerts, latest news and insider tips tailored to your preferences. See what exciting and rewarding opportunities await.

View All