35 Icsr Jobs

Role & responsibilities Perform signal detection to assess the benefit-risk balance of client product Perform EVDAS database review Collaborate across teams to resolve issues and improve signal methodologies. Support regulatory responses and assist in team training. Escalate urgent signals to Line Manager and QPPV. Ensure ongoing signal monitoring from all safety data sources.

As a Safety Surveillance Adviser at Novo Nordisk, your primary responsibility will be to establish the product safety profile during development and maintenance of the labelling for marketed products. Your role will involve performing ongoing and systematic surveillance of Novo Nordisk products, both pre-approval and post-approval, based on safety information from worldwide sources. You will also be responsible for communicating drug safety issues internally and to health authorities. Additionally, you will be required to establish, operate, and chair the cross-functional safety committee, present analysis and results of ongoing safety surveillance, and make recommendations as necessary. You...

Role Overview: As a Clinical Safety Scientist - Lead, your primary responsibility will be to conduct literature reviews to assess ICSR and new safety signals for inclusion in Aggregate reports and DSR (Drug Safety reports). You will also provide MAH comments for selected literature and review Literature Strategy. Additionally, you will be involved in designing and interpreting various types of studies in medicine, assessing levels of evidence, study power for safety analyses, and reviewing outputs triaged by safety scientists for scientific accuracy based on specific criteria. Moreover, you will be responsible for authoring Safety Sections of SSSRs, DSUR, aCO, PBRER, RMP updates, and impleme...

Hiring for Clinical Safety Physician in Mumbai, Bangalore & Noida Any MBBS/MD with min 5 yrs of relevant Exp in Drug Safety, ICSR, Aggregate reporting, Clinical Study Salary up to 25 LPA Call Suhani- 9911988552, Rukhsar-9899875055, Shruti-9911988551

Literature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion in DSR (Drug Safety reports). Provide MAH comments for selected literature Review of Literature Strategy Design and interpretation of various types of studies in medicine, levels of evidence, study power for the purpose of safety analyses. Review of outputs triaged by the safety scientist for scientific accuracy taking into consideration all of the above criteria Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER. Authoring of RMP updates & implementation plans. Review of various types of listings for Signal Detection Must have Skill Set Aggregate report Literature review safety signal IC...

Education MBBS/MD/MS Literature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion in DSR (Drug Safety reports). Review of Literature Strategy Design and interpretation of various types of studies in medicine, levels of evidence, study power for the purpose of safety analyses. Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER (e. g 5.2.4, 6.2, 9.2, 15 & 16). Authoring of RMP updates & implementation plans. Review of various types of listings for Signal Detection Understanding of signal journey and knowledge of signal management systems and process requirements. DSR - Complete authoring, Single case analysis & MAH comments, Drafting Overall Conclusi...

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

Greetings from Wipro!! We are hiring for Pharmacovigilance Case processer @ Pune location Experience- 1- 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 Required- Immediate joiners to 15 days' notice only

Role & responsibilities • Provide timely support for medical assessment of initial case triage and also assist in reviewing medical information queries pertaining to ICSRs. • Able to properly rank event based on seriousness criteria, labeling and causality assessment • Causality assessment for all events based on WHO algorithm and ICH guidelines also taking into consideration vendor conventions specific for different therapeutics areas. • Able to give proper labeling assessment for adverse events with reference to different types of product safety. • Use of global safety database (ARISg, ARGUS) in accordance with company SOPs and regulatory requirements and draft a medical expert or pharmaco...

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...

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...

Key Responsibilities: Literature Management Process - Perform review of literature results retrieved and imported into literature citation management system on a weekly basis and determine if minimum criteria for ICSR is met for marketed products Perform review of literature results to determine if article contains new aggregate safety information in support of the periodic report and/or signal detection Determine whether full text article needs to be ordered and order them if further information is needed to confirm if the citation meets criteria for ICSR or for signal detection Flag articles containing new aggregate safety information for TA Safety to perform secondary review Request Local...

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 I...

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 pha...

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 pha...

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 ke...

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 ...

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. Respo...

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 lo...

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 Owne...

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 ca...

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 fiel...

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 Owne...