Pharmacovigilance Services Specialist
Accenture
5 - 10 years
Chennai
Posted: 14/06/2025
Job Description
Designation: Pharmacovigilance Services Specialist
Qualifications:MBBS/MD
Years of Experience:3 to 5 years
Language - Ability:English(International) - Proficient
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? Performs Medical Assessment activities related to drug safety Pharmacovigilance for the Individual Case Safety Reports - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals - Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP - Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables - Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable - Performs labelling of events of applicable cases - Provides Medical Expertise to case processing team whenever required - Provides training/mentoring to the team members wherever applicable Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements.
What are we looking for? •Understanding of Pharmacovigialnce •Experience in Medical Review of ICSRs •Medical Review
Roles and Responsibilities: - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals - Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP - Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables - Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable - Performs labelling of events of applicable cases - Provides Medical Expertise to case processing team whenever required - Provides training/mentoring to the team members wherever applicableMBBS,MD
About Accenture
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
Equal Employment Opportunity Statement
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.
About Company
Accenture is a global professional services company specializing in consulting, technology, and outsourcing services. Headquartered in Dublin, Ireland, Accenture provides a wide range of services in strategy, digital, technology, operations, and consulting. It helps organizations improve their performance and create sustainable value by leveraging technology and industry expertise. Accenture works across various sectors, including financial services, healthcare, telecommunications, energy, and more. Known for its deep focus on innovation, Accenture partners with leading technology companies to drive digital transformation and help clients navigate complex challenges in an increasingly digital world.
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