Pharmacovigilance Services Associate

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance
Designation:Pharmacovigilance Services Associate
Qualifications:Any Graduation
Years of Experience:1 to 3 years
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? The Pharmacovigilance Case Processing Associate is responsible for the timely and accurate processing of ICSR cases. This includes data entry, narrative writing, case follow-up, and submission per global regulatory guidelines.
What are we looking for? - Bachelor’s Degree in Life Science or Healthcare related field - 0-2 years of pharmacovigilance experience preferred - Excellent written communication and interpersonal skills - Proficient in medical terminology - Meticulous attention to detail and accuracy - Ability to handle large volumes and tight timelines - Strong knowledge of pharmacovigilance guidelines and regulations - Working knowledge of pharmacovigilance databases
Roles and Responsibilities: Enter adverse event case data into the safety database accurately and completely - Retrieve additional case information by contacting reporters/physicians as needed - Write clear, coherent, and scientifically sound adverse event case narratives - Assess seriousness, severity, causality and expectedness for individual cases - Determine reportability of cases and submit expedited and periodic reports to regulators - Classification of medical conditions and assignment of MedDRA codes for cases - Follow up with reporters/physicians for missing case information as applicable - Comply with all global regulatory reporting requirements and company procedures - Maintain up-to-date knowledge of changing safety regulations and guidelines