AddressSkill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance
Designation:Pharmacovigilance Services Sr Analyst
Qualifications:Bachelor of Pharmacy/Master of Pharmacy/Master Of Physiotherapy
Years of Experience:5 to 8 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 Inline Quality Check Associate is responsible for performing quality checks of ICSRs processed by the safety case processing team. This role ensures accuracy, completeness and compliance to guidelines prior to case submission to regulators.
What are we looking for? - Bachelor’s Degree in Life Sciences or related field - 4-6 years’ experience in pharmacovigilance quality assurance is preferred - Working knowledge of drug safety regulations for adverse event case processing - Keen attention to detail with analytical and data validation abilities - Strong communication and collaboration skills - Highly organized and process-oriented - Proficient in using pharmacovigilance databases and applications
Roles and Responsibilities: Perform 100% inline quality check on all adverse event cases processed internally - Verify accuracy and completeness of adverse event case data entered in safety database against source documents - Ensure adverse event case processing meets global regulatory and reporting compliance guidelines - Highlight data discrepancies, missing information or process non-compliance for correction by case processors - Compile quality verification findings, metrics and audit observations to highlight areas of concern - Support creation of reference data sets for quality checking of specific case parameters - Participate in case processing and quality improvement initiatives within the department - Understand current pharmacovigilance regulations and guidelines for adverse event reporting - Adhere to departmental Standard Operating Procedures (SOPs)
Bachelor of Pharmacy,Master of Pharmacy,Master Of Physiotherapy
