18 Icsr Jobs

As a Medical Reviewing PV Author, your primary responsibility will be to review and author Clinical Comment (CCC) for case reports involving Suspected Unexpected Serious Adverse Reactions (SUSAR). You will be tasked with editing the Periodic Report Comment within the Patient Safety database, if applicable. Additionally, you will be expected to engage in activities within the Comments field of the GSP Review Workflow step in the Patient Safety database. This includes reviewing and responding to queries/comments from the Case Owner, which are documented in the Comment field of the GSP Review Workflow step. Your role as Lead Medical reviewer will require strong skills in Pharmacovigilance and ICSR. The industry type for this position is IT/Computers - Software, with a functional area focus on the Pharmaceutical sector. This is a full-time, permanent position falling under the Role Category of Life Sciences and Pharma. If you are passionate about ensuring patient safety through rigorous medical review processes and possess the necessary skills in Pharmacovigilance and ICSR, we encourage you to apply for this role. Please note the following details for the job: - Job Code: GO/JC/21470/2025 - Recruiter Name: Sangeetha We look forward to potentially welcoming you to our team as a key member in our Medical Reviewing PV Author role.,

Job Title : Pharmacovigilance Specialist Location : Bangalore / Hyderabad Experience : Minimum 4 Years in PV ICSR Job Summary We are seeking a skilled and detail-oriented Pharmacovigilance (PV) Specialist with hands-on experience in Individual Case Safety Reports (ICSR) . The ideal candidate will be responsible for end-to-end case processing and ensuring compliance with global PV regulations and internal SOPs. Key Responsibilities : Perform case intake, triage, data entry, quality review, and submission of ICSRs. Evaluate and code adverse event reports using MedDRA and WHO-DD coding. Ensure timely reporting of adverse events to regulatory authorities and clients. Maintain compliance with pharmacovigilance regulations (e.g., FDA, EMA, CDSCO). Collaborate with cross-functional teams to ensure accurate and complete safety data. Contribute to audit and inspection readiness. Prepare periodic safety update reports (PSURs) and other regulatory documents when required. Qualifications : Bachelors or Masters degree in Pharmacy, Life Sciences, or related field. Minimum 4 years of hands-on experience in PV ICSR processing. Strong understanding of global PV regulations and ICH-GCP guidelines. Familiarity with PV databases (e.g., Argus, ArisG) is an advantage. Excellent attention to detail and strong analytical skills. Good communication and documentation skills. Preferred Attributes : Certification in Pharmacovigilance will be an added advantage. Ability to work independently and as part of a team. Willingness to work in shifts if required (based on client/region).

Job Title : Pharmacovigilance Specialist Location : Bangalore / Hyderabad Experience : Minimum 2 Years in PV ICSR Job Summary We are seeking a skilled and detail-oriented Pharmacovigilance (PV) Specialist with hands-on experience in Individual Case Safety Reports (ICSR) . The ideal candidate will be responsible for end-to-end case processing and ensuring compliance with global PV regulations and internal SOPs. Key Responsibilities : Perform case intake, triage, data entry, quality review, and submission of ICSRs. Evaluate and code adverse event reports using MedDRA and WHO-DD coding. Ensure timely reporting of adverse events to regulatory authorities and clients. Maintain compliance with pharmacovigilance regulations (e.g., FDA, EMA, CDSCO). Collaborate with cross-functional teams to ensure accurate and complete safety data. Contribute to audit and inspection readiness. Prepare periodic safety update reports (PSURs) and other regulatory documents when required. Qualifications : Bachelors or Masters degree in Pharmacy, Life Sciences, or related field. Minimum 2 years of hands-on experience in PV ICSR processing. Strong understanding of global PV regulations and ICH-GCP guidelines. Familiarity with PV databases (e.g., Argus, ArisG) is an advantage. Excellent attention to detail and strong analytical skills. Good communication and documentation skills. Preferred Attributes : Certification in Pharmacovigilance will be an added advantage. Ability to work independently and as part of a team. Willingness to work in shifts if required (based on client/region).

Role & responsibilities The responsibilities of the role include processing Individual Case Safety Reports (ICSRs) and conducting literature screening activities. The candidate will be responsible for reviewing and assessing the validity of literature abstracts and articles, with further processing into the safety database as required. Additionally, the role involves maintaining the Extended Eudravigilance Medical Product Dictionary (XEVMPD) and performing EVWEB updates, including revisions to the Summary of Product Characteristics (SPC/SmPC) and Patient Information Leaflets (PILs). The candidate will also perform comparative reviews of SmPC and PIL documents against reference products. A key responsibility includes the preparation and maintenance of Risk Management Plans (RMPs), which involve identifying potential risks, outlining mitigation strategies, and ensuring regulatory compliance. Continuous monitoring of safety updates and detection of safety signals for client products is essential. All activities must be conducted in strict compliance with standard operating procedures (SOPs) and applicable regulatory requirements. Preferred candidate profile Eudravigilance, XEVMPD Maintenance, and EVWEB Updates Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) Risk Management Plan (RMP) and Regulatory Documentation ICSR Processing and Reference Product Comparison

Role & responsibilities Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, time sheet approval, and employee counseling. Advises staff on administrative policies and procedures, technical problems, and prioritization. Assigns project work and reviews workload for all direct reports. Provides oversight and guidance on organizational goals and company objectives. Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan. Discusses below-target project goals with senior safety management. Manages projects where Safety and Pharmacovigilance are the primary services. o Reviews study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed. o Works with Finance to ensure appropriate customer invoicing, where required. o Approves project time cards and invoicing. o Provides sponsors with scheduled project updates and reports. o Coordinate with other internal departments and Safety functional areas to ensure timely review and submission of reports and documents relating to safety reporting as well as resolution of issues. Participates in the management of the Safetyand Pharmacovigilance department with the following actions: o Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs) o Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety Reporting Plan. o Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes. Participates in process development and improvement of departmental functions. o Works with Business Development to actively solicit new business, as needed. o Represents Safety and Pharmacovigilance or ensure Safety representation at project team meetings and client meetings. Reviews, advises, and approves Safety portions of project proposals to ensure wording adequately reflects the scope of work for Safety and Pharmacovigilance. Participates in bid defense meetings. Reviews clinical safety sections of study protocols and Case Report Forms (CRFs) to make sure information is consistent with the Serious Adverse Event form. Approves budget projections for the project. Maintains understanding and ensures compliance of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, study plans and the drug development process. Responsible for the identification, preparation, and delivery of any necessary training to Safety team members and other Syneos Health departments or groups. Mentor Safety team members Managing resourcing's needs/issues and escalating to senior management as necessary. Participates in audits/inspections and ensures inspection readiness. Participates in quality investigations and implementation of corrective and preventive actions. Performs other work related duties as assigned. Minimal travel may be required. Qualifications - Must be a N3 or above certified (JLPT) Japanese Language professional - BA/BS in the biological sciences or related disciplines in the natural science/health care field or nursing degree or equivalent combination of education and experience Progressive responsibility with demonstrated leadership skills and project management Clinical Research Organization (CRO) experience with therapeutic specialties preferred Working knowledge of financial budgets and various financial analysis tools preferred Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), and internet Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills Ability to establish effective relationships with clients as well as team members Ability to be flexible, adapt to change, work independently, as well as part of a teamin a matrix environment Ability to make effective decisions and manage multiple priorities while delivering high quality work in a dynamic environment

Job Responsibilities: (Medical Reviewing - PV) Performing the Case Analysis and Peer Review (Quality check) Perform medical review (including verifying the coding & labelling reviewing narratives causality statement medical aspect of follow-up request) validate follow-up request and perform medical assessment of the case for the Category I and II cases Prioritize workloads to ensure expedited cases are processed within defined timelines Responsible for the timely completion of individual cases and meeting the SLA for data entry and case analysis activity as per SOP. Approval and the locking of Category I cases Responsible for the timely reception of an individual case on a daily basis. Responsible for registration in e-logbook and for the duplicate search process. Ensure quality and timely creation and closure of PV query as per SOP. Ensure the filing of PV dossier and documents as per the SOP Contact Person : Sangeetha Tamil

Role- Medical Reviewer(MCI Cert.) MBBS/MD Graduates with 1 yr to 8 yrs of Clinical/Non Clinical Exp in Clinical Trials, PV, ICSR, SUSAR 5 Days WFO| 2 RWO| General Shift SALARY UP-TO 18LPA CALL- RUKHSAR- 9899875055 SUHANI- 9911988552 Divya- 9911988842

Job Description: Accountable for the medical review of relevant clinical, other solicited and spontaneous cases (including literature articles), medical assessment (including labeling and causality along with the company causality statement) 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 Developing and maintaining thorough knowledge of the appropriate disease biology areas & important safety concerns for marketed drugs and drugs in development Assuring and maintaining compliance with regulatory and local/global SOP timelines Supporting the Drug Safety teams with medical concepts and awareness of product related topics to ensure quality of adverse event data processing Representing safety physician team in internal and client safety forums and audits Review and respond to any queries/comments for an individual case safety report in the Patient Safety database. Responsible for generating, sending, and tracking medically relevant queries for follow-up information that is required for an individual case safety report Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR) Ensure compliance with global and local procedural documents and implementation of client and , policies, procedures, and processes. Skills required: Computer Literate (e.g., knowledge of MS Office) Aptitude for self-directed learning Good medical knowledge and its application in drug safety

Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) 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. 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. 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 ( Mumbai ) Type : Job Code # 47 b) To Apply for above Job Role ( Pune ) Type : Job Code # 48 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 51

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

We are Hiring for Leading ITES Company for Medical Reviewer Profile Pls Apply, We shall call back the relevant profiles. Experience :- Min 1 years of experience in Medical Reviewer domain Job Description for Medical Reviewer 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. 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 ( Mumbai ) Type : Job Code # 47 b) To Apply for above Job Role ( Pune ) Type : Job Code # 48 c) To Apply for above Job Role ( Nagpur ) Type : Job Code # 49

We are seeking a skilled Business Analyst with experience in healthcare and life sciences to translate complex domain requirements into clear functional specifications. The role focuses on supporting product development initiatives by aligning business needs with technical solutions across the PDLC. Requirement Gathering & Analysis Business Analyst Product Development Lifecycle (PDLC) Pharmacovigilance (PV) ICSR IQVIA Vigilance Platform Clinical Trials Regulatory Affairs Medical Affairs Risk-Based Quality Management Veeva CTMS Safety Intelligence CluePoint Signal Oversight Labeling Management Product Traceability Randomization

Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) 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. 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. 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 Mumbai Search : Medical Reviewer Mumbai (Job Code # 47) b) For Position in Pune Search : Medical Reviewer Pune (Job Code # 48) c) For Position in Bangalore Search : Medical Reviewer Bangalore (Job Code # 51)

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

We are Hiring for Leading ITES Company for Medical Reviewer Profile Pls Apply, We shall call back the relevant profiles. Experience :- Min 1 years of experience in Medical Reviewer domain Job Description for Medical Reviewer 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. 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 Mumbai Search : Job Code # 47 b) For Position in Pune Search : Job Code # 48 c) For Position in Nagpur Search : Job Code # 49

Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) 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. 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. 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 Mumbai Search : Medical Reviewer Mumbai (Job Code # 47) b) For Position in Pune Search : Medical Reviewer Pune (Job Code # 48) c) For Position in Bangalore Search : Medical Reviewer Bangalore (Job Code # 51)

Qualification: MBBS Experience: 1 to 3 years Previous experience in medical review of ICSRs. Knowledge of safety databases, such as Argus, ARISg, or similar systems. Familiarity with medical coding dictionaries (e.g., MedDRA) and adverse event reporting standards (e.g., ICH E2B). Strong attention to detail and ability to work with complex medical data. Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders. Key Responsibilities: Individual Case Safety Reports (ICSRs) Review: Conduct thorough and objective medical review of ICSRs received from various sources, including clinical trials, spontaneous reports, and literature. Assess the medical relevance and causality of adverse events reported in ICSRs. Identify and evaluate potential safety signals and perform appropriate follow-up actions as necessary. Ensure accurate and timely reporting of serious and non-serious adverse events to regulatory authorities.

We are Hiring for Leading ITES Company for Medical Reviewer Profile Pls Apply, We shall call back the relevant profiles. Experience :- Min 1 years of experience in Medical Reviewer domain Job Description for Medical Reviewer 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. 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 Mumbai Search : Job Code # 47 b) For Position in Pune Search : Job Code # 48 c) For Position in Nagpur Search : Job Code # 49