Avinash Singh Email & Phone Number

Mysore, Karnataka, India

• Work closely with Client and Software Product Unit management to define strategy for Pharmacovigilance & Safety solution.
• Provide functional expertise for new implementation, upgrade, configuration, data migration, report development and application support related tasks.
• Participate in all System validation activities such as IQ/OQ/PQ/MQ for drug safety solutions and author the validation documents.
• Provide functional leadership for internal and customer allocated project… Show more
• Provide functional leadership for internal and customer allocated project teams and hold responsibility for ensuring that project timelines are met.
• Offer functional support in resolving application issues raised by customers.

Pune, Maharashtra, India

 Oversee Drug safety monitoring team including QC review of cases and follow-up query management activities. Established and maintained effective project communications by representing my team at interdepartmental project/product team meetings, Partner/Vendor meetings and provide global collaboration. Manage relationships with Safety vendors, Business.

Pune, Maharashtra, India

 Oversee Drug Safety Monitoring Team including QC review of cases and Follow-up Query Management Activities. Started Workflow Allocation and Process Improvement Initiatives Support/train less experienced/new safety staff in all aspects of case-handling, adverse event reporting. Assume the role of Subject Matter Expert (SME), participate & support in.

Pune, Maharashtra, India

 Handled AE/SAE reports from multiple CT & PMS for submission to worldwide regulatory authorities according to applicable regulations and guidelines, standard operating procedures (SOPs), and Project requirements. Quality review of the ICSRs and providing the appropriate feedback to the associates. Generation of correction form as required according to.

Bengaluru, Karnataka, India

 Review, assess, triage, process, quality review and report the adverse event reports from spontaneous source and clinical trials according to applicable regulations, guidelines, SOPs and project requirements within the specified time lines by meeting the quality standards.  Ensure a duplicate check is conducted against the Global Safety Database in.

Bengaluru, Karnataka, India

 Performing case registry and triage of incoming cases to determine seriousness for prioritization of daily workflow Confirmation of previously entered data and completion of data entry, including coding adverse events, medical history, drugs and reported adverse event terms in safety database using medical dictionaries like MedDRA, and WHO-DRL and.

Master Of Pharmacy, Pharmaceutical Chemistry, 72.2% (First Class)

Bachelor Of Pharmacy - Bpharm, 67.4% (First Class)