Drug Safety Quality Associate Manager - LOCATION NEGOTIABLE

  • Accenture Federal Services
  • Oct 14, 2020
Full time Professional Services

Job Description

Job Description

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 world’s 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.


The Drug Safety Quality Associate Manager 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.


They are 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 Drug Safety Quality Associate Manager works as a part of Pharmacovigilance (PV) 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 SLA’s. They are responsible for the evaluation and quality check (QC) of adverse events and relevant  fields and maintaining high standard of accuracy, in compliance with client's, standard operating procedures and global regulatory requirements.


Key Responsibilities:

  • Ensure accurate and consistent coding of medical history, drugs and adverse event terms
  • Assess adverse event reports for seriousness, causality and expectedness as per applicable labelling, consulting the medical safety expert whenever needed
  • Alert the medical safety physicians to potential safety issues
  • Perform quality review of ICSRs and generate follow-up questions as appropriate
  • Conduct causality assessments for safety cases reports
  • Contribute to submissions of ICSRs when required
  • Contribute in generating responses to regulatory authority requests on product safety related issues for marketed products or product in development
  • Respond to queries from clients (including internal and external to the client) in a timely manner
  • Perform monthly or quarterly reconciliations of reports as required
  • Contribute to maintenance and compliance oversight of PV processes, and also may contribute to preparation and internal training on adverse events reporting
  • To mentor and train new hires or other associates
  • Open to get trained and move across roles based on business requirement
  • Successfully complete and clear proficiency test
  • Ensure that post marketing adverse events are evaluated accurately and within the required timeframes to meet regulatory requirements
  • Number, timeliness and scientific quality of deliverables according to established directives

Job Requirements:


Travel: Once a year to Berwyn, PA

Working Hours:  9-5 EST

Location: Negotiable within the US, must live within 100 miles of an Accenture office





Basic Qualifications

  • Bachelor’s degree in Health or Life Sciences (Nursing, Pharmacy, Dentistry, Physiotherapy, Biology, Microbiology, Biochemistry etc)
  • Minimum of 1 year Pharmacovigilance/ Drug Safety Case review experience

Preferred Skills

  • Clinical nursing experience
  • Experience in pharmacovigilance or clinical research
  • Thorough knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug

Professional Skills

  • Good medical writing skills
  • Good knowledge of assigned therapeutic areas and relevant Client drugs
  • Good Communication Skills
  • Analytical skills
  • 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.


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


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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.


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Other Employment Statements


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


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