Signal Detection Senior Analyst
Overall Purpose of the Job
Responsible for medical review and leading the Signal Management activities including weekly literature review, authoring of signal reports (Signal Management aid Review Team reports) and project management of Safety Surveillance team meeting within the agreed timeframes and accuracy, in compliance with business miles, standard operating procedures (SOP) and global regulatory requirements, all as documented in Quality documents as applicable.
Responsibilities:
Safety assessment - Literature review: On a weekly basis, review abstracts and articles for safety signals and/or for possible inclusion in the aggregate reports and record assessments in appropriate trackers. Liaise with Global Safety Officer (GSO") Pharmacovigilance (PV) Scientist if a potential safety signal is identified upon review of the weekly alerts or in case of doubt. summary of articles of interest for GSO review with PV Scientist in copy in advance of the meetings. Complete the Literature Search Alert Tracker once GSO response received.
Meeting: Liaise with counterpart to identify the attendees and stakeholders for meeting. Schedule meetings and liaise with stakeholders and collate all the necessary data for review. Draft the meeting report in the Electronic Data Management System using the applicable template. Compile and distribute the report applicable stakeholders prior to the meeting. Host the meeting and document the review and any applicable action items in the report. Update the report and distribute it for review. Address the review comments and compile the draft for quality check. Finalize the report after addressing the QC comments and Route the final report to GSO for approval. Enter information from the meeting in the Safety Surveillance and Aggregate Reports (SSA) tracker.
Meetings: Liaise with PV Scientist to define the attendees and stakeholders for meeting. Schedule the meetings and send Request for Information to the shareholders. Compile the slide deck based on input from stakeholders. Prepare meeting minutes using the applicable template.
Perform the Signal management activities as per SOPs, Job Aids and guidelines as agreed during the meetings and/or weekly team meeting.
On -time escalation of any delayed inputs/ review comments/ endorsement as per process.
Archive the supporting documents used to, prepare the aggregate reports in the SharePoint or electronic repository as per the defined timelines
Provide responses to the query related to reports as per the requested timeline · Complete the training as per the assigned timeline
Work with the IT systems where required (Tableau, BEAMS and SharePoint).
Educational requirement: Medical Degree (MBBS or MD)
Work experience requirement: mandatory 2 to 3 years of experience in safety signal detection.
Prior experience with safety database systems (e.g., Argus, ARISg) safety signal detection tools or PV/Aggregate reporting experience is desirable.
Strong understanding of pharmacovigilance regulations, guidelines, and requirements (e.g., ICH, FDA, EMA).
Excellent analytical skills, attention to detail, and ability to critically evaluate safety data. Effective communication and interpersonal skills, with the ability to collaborate with internal and external stakeholders.
Prague
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 such as for a disability or religious observance, please call us toll free at 1 (877) 889-9009 or send us an email or speak with your recruiter.
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, 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. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.
For details, view a copy of the Accenture Equal Opportunity Statement
Accenture is an EEO and Affirmative Action Employer of Veterans/Individuals with Disabilities.
Accenture is committed to providing veteran employment opportunities to our service men and women.
Other Employment Statements
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.
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. Further, at Accenture a criminal conviction history is not an absolute bar to employment.
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.
California requires additional notifications for applicants and employees. If you are a California resident, live in or plan to work from Los Angeles County upon being hired for this position, please click here for additional important information.
Please read Accenture’s Recruiting and Hiring Statement for more information on how we process your data during the Recruiting and Hiring process.
We work with one shared purpose: to deliver on the promise of technology and human ingenuity. Every day, more than 775,000 of us help our stakeholders continuously reinvent. Together, we drive positive change and deliver value to our clients, partners, shareholders, communities, and each other.
We believe that delivering value requires innovation, and innovation thrives in an inclusive and diverse environment. We actively foster a workplace free from bias, where everyone feels a sense of belonging and is respected and empowered to do their best work.
At Accenture, we see well-being holistically, supporting our people’s physical, mental, and financial health. We also provide opportunities to keep skills relevant through certifications, learning, and diverse work experiences. We’re proud to be consistently recognized as one of the World’s Best Workplaces™.
Join Accenture to work at the heart of change. Visit us at www.accenture.com.