8 Safety Database Jobs

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 reporting of expedited reports in accordance with applicable regulatory requirements. - Maintains safety tracking for assigned activities. - Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required. - Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA. - Manual recoding of un-recoded product and substance terms arises from ICSRs. - Identification and management of duplicate ICSRs. - Activities related to SPOR / IDMP. - Quality review of ICSRs. - Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. - Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process. - Fosters constructive and professional working relationships with all project team members, internal and external. - Participates in audits as required/appropriate. - Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

JOB DESCRIPTION: Primary Job Function: The position holder is responsible for retrieving data from the Global Safety Database and associated systems. Core Job Responsibilities: Responsibilities include but are not limited to: Provide business support for other functions in GPV by providing safety data in appropriate quality, timeline, and format. Perform pre-defined validated queries (e.g., PSUR listings) or develop new ad hoc queries. Supervisory/Management Responsibilities: Direct Reports: None Indirect Reports: None Position Accountability/Scope: Producing high-quality safety data reports in line with applicable guidelines and Abbott SOPs. Works with supervision and guidance. Minimum Education: Degree in IT or documentation sciences or comparable education. Good command of the English language. Minimum Experience/Training Required: Minimum two years experience in data retrieval of Safety database mandatory. IT experience in the pharmaceutical industry and validation experience mandatory. Advanced programming skills in SQL mandatory. Very good communication and presentation skills (oral and in writing) in German and English. Training according to assigned ISOtrain curriculum. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Product Development DIVISION: EPD Established Pharma LOCATION: India Mumbai : BKC Building ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Senior Analyst Qualifications: Any Graduation,Bachelor of Pharmacy,Any Graduation Years of Experience: 5 to 7 years Language - Ability: Japanese - Elementary 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 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. 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 You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.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 Agility for quick learning Ability to work well in a team Commitment to quality JLPT (N3 to N5) Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Show more Show less

As a Safety Associate, you will be responsible for reviewing, assessing, and processing safety data and information across service lines. Your key duties will involve distributing reports/data to internal and external parties, ensuring compliance with applicable regulations, SOPs, and internal guidelines, and working under the guidance of senior operations team members. You will need to prioritize and complete assigned trainings on time and process safety data according to regulations, guidelines, SOPs, and project requirements. Your role will also include performing pharmacovigilance activities such as collecting and tracking incoming Adverse Events (AEs)/endpoint information, determining the status of events, database entry and AE/product coding, writing narratives, and literature-related activities. To excel in this position, you must meet quality, productivity, and delivery standards while ensuring compliance with all project-related processes and activities. Additionally, you will be required to create, maintain, and track cases as per the project plan, identify and escalate quality issues to senior team members, and demonstrate problem-solving capabilities. As part of your responsibilities, you may mentor new team members if assigned, attend project meetings, and provide feedback to the operations manager. It is essential to maintain 100% compliance with people practices and processes and perform any other duties as assigned. Your technical skills should include good knowledge of medical terminology, a working knowledge of safety databases, basic knowledge of regulatory requirements, excellent attention to detail and accuracy, as well as good working knowledge of Microsoft Office and web applications. Strong organizational and time management skills, effective communication skills, self-motivation, flexibility, independence, and initiative are also required. You should also possess multitasking and prioritization abilities, delegation skills, learning agility, teamwork and collaboration skills, and a commitment to quality assurance. Moreover, your role will involve demonstrating IQVIA Core Values in daily tasks, utilizing communication tools extensively, and adapting to work conditions such as regular sitting for extended periods, occasional travel, and flexibility to work in shifts. For this position, a B.Pharm / M.Pharm / Pharm.D degree or a High School Diploma or equivalent in a scientific or healthcare discipline is required. Alternatively, a Bachelor's Degree in a relevant field with 1-1.5 years of experience is also necessary to meet the educational qualifications for this role.,

Hi We are hiring for the leading ITES Company for the Medical Reviewer Role. Qualification - MBBS/MD is Must (Full TIme) Job Overview: The Medical Reviewer is responsible for the evaluation and analysis of clinical data to ensure accuracy, compliance with regulations, and the highest quality standards. This role involves reviewing clinical trial data, medical documentation, and regulatory submissions to support the approval of new medical products and therapies. Key Responsibilities: Clinical Data Review : Evaluate clinical trial data for completeness, accuracy, and adherence to protocols. Ensure data integrity and consistency across various documents and databases Medical Documentation: Review and verify the accuracy of medical documentation, including patient records, case reports, and clinical study reports. Ensure documentation complies with regulatory requirements and company standards. Regulatory Compliance: Stay updated with the latest regulatory guidelines and ensure all reviews align with current regulations. Prepare and review regulatory submissions to ensure timely and successful product approvals. Training and Development: Stay informed about advancements in medical research and regulatory changes. Participate in continuous training and development programs to enhance knowledge and skills. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Pune ) Type : Job Code # 48 b) To Apply for above Job Role ( Chennai ) Type : Job Code # 52 c) To Apply for above Job Role ( Indore ) Type : Job Code # 53

Hi We are Hiring Leading ITES Company for Medical Reviewer Role. Please go through the JD and Apply Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. Ensure compliance with global and local procedural documents and local implementation of client Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Nagpur ) Type : Job Code # 49 b) To Apply for above Job Role ( Gandhinagar ) Type : Job Code # 50 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 51

Hi We are hiring for the leading ITES Company for the Medical Reviewer Role. Qualification - MBBS/MD is Must (Full TIme) Job Overview: The Medical Reviewer is responsible for the evaluation and analysis of clinical data to ensure accuracy, compliance with regulations, and the highest quality standards. This role involves reviewing clinical trial data, medical documentation, and regulatory submissions to support the approval of new medical products and therapies. Key Responsibilities: Clinical Data Review : Evaluate clinical trial data for completeness, accuracy, and adherence to protocols. Ensure data integrity and consistency across various documents and databases Medical Documentation: Review and verify the accuracy of medical documentation, including patient records, case reports, and clinical study reports. Ensure documentation complies with regulatory requirements and company standards. Regulatory Compliance: Stay updated with the latest regulatory guidelines and ensure all reviews align with current regulations. Prepare and review regulatory submissions to ensure timely and successful product approvals. Training and Development: Stay informed about advancements in medical research and regulatory changes. Participate in continuous training and development programs to enhance knowledge and skills. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Chennai Search : Medical Reviewer Chennai (Job Code # 52) b) For Position in Indore Search : Medical Reviewer Indore (Job Code # 53)

Hi We are Hiring Leading ITES Company for Medical Reviewer Role. Please go through the JD and Apply Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. Ensure compliance with global and local procedural documents and local implementation of client Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Nagpur Search : Job Code # 49 b) For Position in Gandhinagar Search : Job Code # 50 c) For Position in Bangalore Search : Job Code # 51