610 Case Processing Jobs - Page 14

Pharmacovigilance (PV) Quality Assurance System Governance. Maintaining oversight of the quality systems within Pharmacovigilance department. Review &/or Approval of Quality system documents related to Pharmacovigilance. Ensure compliance with written procedures/policy/manuals. Ensure all time readiness of Pharmacovigilance function for client audits/visits and regulatory inspections. Handling of External Audits, Regulatory Inspections, & client visits related to Pharmacovigilance function. Monitor the deficiencies and deviations within PVD and shall ensure compliance and implementation of Corrective and Preventive Actions (CAPA) in accordance with relevant QMS SOP. On-boarding & training of...

Analyses, reviews, and interprets safety data, both non-clinical and clinical, literature and any other relevant sources Responsible for performing end to end case processing of Individual case safety reports to meet regulatory timelines Perform initial evaluation of spontaneously reported adverse events including reports from post marketing surveillance studies Responsible for identifying duplicate/invalid ICSRs Perform case processing from clinical trial, literature, spontaneous, market research, social media and solicited cases for both serious and non-serious reports Perform data entry for all subject information into EDC databases as required Perform peer review, quality review of cases...

Review of the world wide scientific and medical literature in accordance with companies-controlled documents. Maintain organized records of all literature safety reports received and reported. Basic entry of MLM cases received from the authority by uploading and importing XML and RTF files and by analysing received source document. Perform duplicate check. Manage tracking of MLM cases with source of receipt. Ensuring compliance with local regulations and companys global pharmacovigilance requirement. Weekly reconciliation of MLM cases with source of receipt. Deliver training to new joined and team as per requirement. Case processing including data entry, drug coding, MedDRA coding, assessmen...

Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR for submission to local and other Health Authorities. Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities. Authoring of Signal Management Reports. Performing literature search and validity check for the aggregate reports. Reconciliation of relevant process trackers. Extraction and validation of data (RSI, Sales, previous reports, RMP, signals). Generation of Line Listings (LL) from safety database Providing reliable support for high priority Ad-hoc activities. Ensure all the reports are drafted within the allocated timelines.

This role as a Training Operations Specialist within Global Patient Safety (GPS) sounds like a pivotal position for ensuring the effectiveness and compliance of training initiatives. You'd be the backbone supporting the strategic training goals of the department. Here are some key takeaways from the description: Focus on Operational Excellence in Training: Your work will directly contribute to ensuring that all GPS roles are well-equipped, which is crucial for maintaining high standards in patient safety and regulatory compliance. Lifecycle Support for Employees: You'll be involved in the entire employee lifecycle from onboarding to offboarding, ensuring smooth transitions and knowledge rete...

Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support. Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-mar...

We are seeking an experienced and detail-oriented Medical Reviewer to join our team. The role involves reviewing, analyzing, and ensuring accuracy, consistency, and compliance of medical and scientific content in alignment with regulatory, clinical, and organizational standards. Key Responsibilities Review medical, clinical, and regulatory documents for scientific accuracy, clarity, grammar, and compliance. Ensure consistency of terminology, data, and style across all documents. Validate clinical and safety data in reports and submissions against source documents. Collaborate with cross-functional teams including medical writers, clinical research, and regulatory affairs. Provide feedback an...

SUMMARY SAR & SAR-like Patient Safety Physician Job Description Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborating with Therapeutic Head to identify signals and address product safety concerns Engaging with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensuring 100% compliance with timely completion of all client and Cognizant required trainings Achieving 100% compliance with work allocation plan, including case clos...

Greetings from Wipro!! We are inviting applicant for Walk-in Drive-in Pune Location for Pharmacovigilance Experience- 1 to 2 years Qualification- B. Pharm/ M. Pharm with valid Pharma license Only the qualifications mentioned are eligible Candidate should have excellent Communication in English Should be ready for Rotational shifts Should have excellent knowledge of Pharmacovigilance Should be ready to work from office Should be ready to relocate to Pune Walk In Date- 4-Sep -25 Time to Report- 9.30 A.M- 11 A.M Documents to carry- Update CV & original govt. ID Card. Should mention at the top of the CV the source of information about the walk-In Walk in Address- Unit 2, Plot No 31, Hinjewadi Ph...

Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations In...

About The Role Credit Card Process Manager Marketing HO Department Credit Card Products Location Infiniti IT park Reporting Relationship Position Grade Senior Manager Job Role Process designing for Credit Cards covering key aspects of Process Workflows (Digital / Physical), Compliance, Risk, Legal, Ops, Customer Experience, etc. Creating and documenting SOPs/Process notes of various Credit Card processes with clear defined roles and responsibilities to promote efficient implementation. Ability to think through end to end process at various touchpoints such as online channels, partners, Branches, Call center etc. Review processes in light of Fraud and Risk raised by RCU and ORM. Identificatio...

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture 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 worlds 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. Visit us at www.accenture.com ...

About The Role Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Senior Analyst Qualifications: BCom Years of Experience: 5 to 8 years Language - Ability: English(Domestic) - Intermediate About Accenture 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 worlds 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. Visit us at www.accenture.com Wha...

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture 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 worlds 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. Visit us at www.accenture.com ...

Role & responsibilities Contributing to maintain or improve quality performance and compliance of operational PV activities Ensuring Deviation and CAPA Management, Change Control, Document Control, and other Quality Management System activities Developing, managing, and executing quality management processes to ensure quality standards are maintained and compliant with regulatory requirements Coordinating PV audits and Inspections Preparation and management of Pharmacovigilance System Master File (PSMF) Generation, quality review, and distribution of compliance and quality metrics and trending activities. Coordinating compliance, quality, and process improvement initiatives while providing i...

Quality Control based in Waghodia, Vadodara The ideal candidate brings 4-7 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Additional info: R...

Quality Assurance based in Waghodia, Vadodara. The ideal candidate brings 3-10 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Strengthen ...

Regulatory affairs professional with experience in managing product listings for different markets and ensuring full compliance with all regulations. Proven track record of collaborating with renowned global cosmetic brands to navigate and meet regulatory requirements across multiple regions, including the USA, Canada, Australia, New Zealand and Middle East. Proficient in cosmetic regulations, including several regulations and versed with interpreting and applying recent regulatory updates. Highly skilled in managing compliance with state-specific regulations. Adept at leading cross-functional teams to support regulatory submissions and ensure product compliance, driving efficiency and marke...

You will be providing medical safety expertise to Sponsors of drugs, devices, and combination products during the post-marketing period. Your responsibilities will include conducting primary medical review of cases, assessing seriousness, listedness/labeling, causality, adverse event coding, and narrative review. Daily case data update and documentation, along with feedback in appropriate trackers/tools, will be essential for efficient tracking and workflow management. It will be your responsibility to ensure the quality, compliance, and productivity of all assigned deliverables within the expected SLAs and KPIs. After a tenure of 1 year, you will provide training and guidance to the case pr...

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners most high-profile drug and dev...

Job Overview Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period. Summary Of Responsibilities Undertake primary medical review of cases, including medical assessment of the case for seriousness, listed/labeling, causality, adverse event coding and narrative review. Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management. Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs. Provide training and guidance to the case processing team on medical aspects...

Chennai Job ID: SS202400022 Function: Software Role: Catia Automation Desired Skills: Catia Automation, VB Script, Cat Script, EKL Job Description To develop the script to check the standard rules for Architecture and design team to reduce lead time for business delivery with EKL/CAT Script/VBA technologies, 1 7 years of experience in CATIA/CAT Script/EKL Understand the technical functions like Standard Rules and usage from business, Perform the technical feasibility based on the requirement in 3Dexperince/CATIA Create a script to reduce manual activity and increase the lead time Validate the script along with business and change the customization based on the business requirement if require...

Job Responsibilities: - Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. - Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. - Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. - Enters data into safety database. - Codes events, medical history, concomitant medications, and tests. - Compiles complete narrative summaries. - Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. - Assists in the generation of timely, consistent, and accurate repo...

About The Role Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: BCom/MCom/Master of Business Administration Years of Experience: 1 to 3 years What would you do? We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whil...

Responsible for quality management, workload management, compliance management and docaument management for the assigned PV projects Acts as line manager of assigned staff Manages project coordination and resource allocation within the projects Train and mentor PV department staff, as needed Ensures monthly invoices are generated and shared for all PV clients on regular/monthly basis Responsible for recruitment of new staff in PV Department Ensures all departmental CVs, job descriptions and training records are complete and up to date and as per SOPs Is involved in objective setting and annual appraisals of staff Ensures training compliance by PV staff at all times Represents PV department d...