47 Icsr Jobs

You will be responsible for the following tasks: - Entering information into PVG quality and tracking systems for receipt and tracking ICSR as required - Assisting in the preparation of project plans such as Safety Management Plan - Performing set-up, delivery, and close-out of safety and pharmacovigilance projects - Processing ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans - Triageing ICSRs and evaluating ICSR data for completeness, accuracy, and regulatory reportability - Entering data into safety database - Coding events, medical history, concomitant medications, and tests - Compiling complete narrative summaries - Assessing information t...

Openings for Medical Reviewer for Mumbai Location Salary Up-to - 25LPA Ed- MBBS / MD With 1 to 6 Yrs Of Exp In Clinical & Non Clinical ( PV Pharmacovigilance , Drug safety , ICSR & SUSAR ) Call - Kajal - 8595849767 Call - Komal - 8860830840

Role Overview: You will be responsible for conducting literature review to assess ICSR and new safety signals for inclusion in Aggregate report and Drug Safety reports. Additionally, you will provide MAH comments for selected literature and review Literature Strategy. Your role will also involve designing and interpreting various types of studies in medicine for safety analyses and ensuring scientific accuracy of outputs triaged by safety scientists. You will be authoring Safety Sections of SSSRs, DSUR, aCO & PBRER, as well as RMP updates & implementation plans. Reviewing various types of listings for Signal Detection will also be a part of your responsibilities. Key Responsibilities: - Cond...

Key Responsibilities: Approve and schedule reports in the Argus database for submission to respective Health Authorities, as applicable. Submit cases to Health Authorities, Business Partners, and Affiliates as required. Ensure adherence to internal and external timelines for case processing to maintain regulatory reporting compliance. Schedule and approve regulatory reports based on reporting obligations. Job Requirements: Years of Experience: 4 to 6 years of relevant experience in Pharmacovigilance (PV), specifically in ICSR Quality Review and Regulatory Report Submissions. Hands-on experience with the Argus Database is essential. Educational Qualification: B.Pharmacy / M.Pharmacy Skills an...

Inviting applicant for Walk-in Drive-in Pune Location for Pharmacovigilance Experience- 1 Yr to 5 Yrs Qualification - B. Pharm / Nursing / BDS / BAMS / BHMS /LS Graduates Only the qualifications mentioned are eligible Candidate should have excellent Communication in English Should be ready for Rotational shifts Should have excellent knowledge of ICSR Should be ready to work from office Should be ready to relocate to Pune Walk In Date- 1 st December Time to Report- 10 A.M- 12.30 P.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 Phase 2, Rajiv Gandhi Info Tech...

Medical Reviewer Role at Mumbai & Ahmedabad MBBS/MD with min. 2-8 yrs of Clinical/Non Clinical Exp including PV, Clinical Trials Data, ICSA, SUSAR are eligible Salary up-to 13LPA Call/WhatsApp/Email- Rukhsar- 9899875055 | rukhsar.wfm@gmail.com

Role & responsibilities Job Title: Senior Medical Safety Advisor Education Qualification: MBBS/MD. Work Location: Anywhere in India. Work Mode: Home Based. Years of exp: 2+ yrs of Pharmacovigilance. Pls note MCI reg is mandatory for all the foreign medical graduates. Job Overview: Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety's involvement on assigned trials and standalone safety projects with appropriate oversight from management or more senior medical safety directors. Essential Functions : Perform medical review and clarification of trial-related Adverse Events (AEs) an...

Role: Senior Medical Safety Advisor Total Experience: 5+ Years. Pharmacovigilance/PV Experience : 1+ Years Work location & Mode : PAN India -Homebased Education : MBBS/MD Graduates. Must Have Skills: Pharmacovigilance, ICSR. Job Overview The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product's safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix ...

Job Description: Receipt of cases and their assessment to ensure the information is adequate to qualify the case as ICSR. Perform data entry of ICSR by assessing the source documents and ensure the information entered in the Argus database is appropriate as per source documents of the complaint received. Follow up for the information of potential cases as per SOPs if the initial information is inadequate To review cases processed by the case processors for quality, MedDRA coding, narrative, and overall consistency with source documents, SOPs. To provide periodic quality improvement feedback to case processor. To identify areas of improvement in terms of compliance, quality, and productivity....

Role: Senior Medical Safety Advisor Work Experience: 5+ Years. Clinical Experience: 3+ Years. Pharmacovigilance/PV Experience : 2+ Years Work location: PAN India Work Mode: Home Based Must Have Skills: Pharmacovigilance, ICSR. Job Overview The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product's safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matri...

• Process and triage Individual Case Safety Reports (ICSRs) • Ensure data accuracy, completeness, and regulatory compliance • Code medical events, histories, and medications using MedDRA • Support xEVMPD submissions and SPOR/IDMP activities • Maintain documentation in TMF and PV system master files • Collaborate cross-functionally and support audits Must-Have: • Hands-on experience with Argus or ArisG safety databases What You Bring: • Strong understanding of PV regulations, GVP, GCP, and ICH guidelines • Familiarity with global regulatory reporting requirements • Excellent attention to detail and communication skills • Ability to work independently and in a team environment Join a team that...

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 have work experience of minimum 1 year in pharmacovigilance case processing Should be ready to work from office Should be ready to relocate to Pune Walk In Date- 7-Nov -25 Time to Report- 10.00 A.M- 12.30 P.M Documents to carry- Update CV & original govt. ID Card. Should mention at the top of the CV the so...

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...