11 days old

Medical Reviewer Lead ( MBBS / MD / DO )

Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions underpinned by the worlds largest delivery network Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 469,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives.

Visit us at www.accenture.com.

People in our Client Delivery & Operations career track drive delivery and capability excellence through the design, development and/or delivery of a solution, service, capability or offering. They grow into delivery-focused roles, and can progress within their current role, laterally or upward.
services ranging from case intake, case processing, quality & medical review, follow up process and submission of the reports to the regularity authorities across the globe.

The Medical Reviewer is an associate with a Pharmaceutical client for whom Accenture provides end to end single case processing services ranging from case intake, case processing, quality & medical review, follow up process and submission of the reports to the regularity authorities across the globe.

The Medical Reviewer is aligned with our Pharmaceuticals Processes vertical and will help us with the processes to collect, monitor, assess and evaluate information on the adverse effects of medication with a view to identifying new information about adverse events associated with medicines and consequently, prevent harm to patients. It also deals with the reviewing and resolving of discrepancies identified by the system or through manual checks as per guidelines.

The Medical Reviewer works as a part of Pharmacovigilance team and is responsible for the medical evaluation of serious and non-serious cases and safety reports. They will prioritize medical assessment in accordance with regulatory timeline and turn around time SLAs.

Key Responsibilities:
Prioritize medical assessment in accordance with regulatory timeline and SLAs
Confirm that the information in the Global Safety Database is accurate and consistent with the source documents for applicable serious and non- serious cases
Assess/confirm seriousness of case in accordance with regulatory guidelines
Reviews medical content and quality of the case and ensures that all events from the source documents are accurately coded.
Ensures all relevant information is in logical temporal sequence
Assess expectedness/listedness of adverse events: assessment of core listedness, expectedness against IB, EU SmPC, US package insert and Canadian monograph or other local labels as applicable for the ICSR.
Assess causality of events in all solicited reports
Write medical assessment comment
Create medical query action items within the global data base for case related queries to ensure case details are sufficient for medical evaluation
Perform self-review for changes made to case during medical review and E2B validation check for all cases
Complete corrections of the cases as required before routing for distribution
Route the case to distribution
Provide feedback for the case creation and data entry production leads about the quality of data entry in serious cases
Offline peer review of agreed sample of Cases for assessment of quality of narrative, medical assessment comment and medical query completeness
Offline review of line listings as per agreed schedule
Role Requirements

Travel: Once a year to Berwyn, PA
Working hours: Daytime business hours EST/ occasional hours outside this schedule

Basic Qualifications:
Minimum of medical degree (MBBS/MD/DO)
Minimum of 2 years experience in a clinical practice
Preferred Skills:
Experience in pharmaceutical industry (PV, clinical Research, Medical Affairs areas of experience)
In-depth knowledge of medical terminology
In-depth knowledge of assigned therapeutic areas
In-depth knowledge of relevant client drugs
Good communication and medical writing skills
Knowledge of safety database and automation technology
Strong English language proficiency (reading, writing, listening and speaking)
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Accenture.

Equal Employment Opportunity Statement

Accenture is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive and more creative, which helps us better serve our clients and our communities.

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.

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

For details, view a copy of the Accenture Equal Opportunity and Affirmative Action Policy Statement

Requesting An Accommodation

Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.

If you would like to be considered for employment opportunities with Accenture and have accommodation needs for a disability or religious observance, please call us toll free at 1 (877) 889-9009, send us an email or speak with your recruiter.

Other Employment Statements

Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.

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

The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information.


Posted: 2020-10-16 Expires: 2020-11-15

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Medical Reviewer Lead ( MBBS / MD / DO )


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