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12.0 - 20.0 years
50 - 55 Lacs
kolkata, pune, chennai
Work from Office
MBBS Doctor with experience in safety writing and signal detection. ICSR medical review/approval including MedDRA coding, listedness/expectedness,and seriousness assessment. Risk management activities such as drafting, assessment, or implementation of RM activities. Signal management activities such as drafting of qualitative and quantitative signal assessment reports. Clinical practice experience in direct patient care. Aggregate safety report drafting, review or assessment. Must have skill set MedDRA coding Aggregate report signal detection drafting PBRERs Risk Management Plans AE s Contact Person: Maheshwari Balasubramanian Email ID: maheshwari@gojobs.biz
Posted 5 days ago
5.0 - 9.0 years
0 Lacs
karnataka
On-site
As a Medical Content Writer, you will be responsible for: - Reviewing promotional and medical communication materials for various client products to ensure they are medically accurate, scientifically rigorous, truthful, balanced, relevant to the product and therapy area, compliant with pharma regulations and guidelines, and supported by authentic and up-to-date references. - Developing and updating content for various medical materials, conducting literature searches to identify appropriate references, tracking and auditing assets for various purposes. - Developing and reviewing content for various deliverables, meeting quality requirements as per client satisfaction metrics, within assigned...
Posted 1 week ago
6.0 - 11.0 years
20 - 25 Lacs
noida, ahmedabad
Hybrid
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...
Posted 1 week ago
0.0 years
0 Lacs
mumbai, maharashtra, india
On-site
This job is with Johnson & Johnson, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal.?Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.?Learn more at ht...
Posted 1 week ago
8.0 - 12.0 years
0 Lacs
karnataka
On-site
As the Project Safety Specialist, your primary responsibility will be to manage client or project-specific PSS operations associated with products, including the entire adverse events process. This may involve handling safety data collected from clinical trials and/or post-marketing settings for specified projects. Your role will require you to manage and process expedited adverse events to the required standard and submit them to the client and regulatory agencies within agreed timelines. You will be providing this service to clients either as a support function to client project groups or as a stand-alone business, ensuring the delivery of high-quality service in a safe and cost-effective ...
Posted 1 week ago
3.0 - 7.0 years
4 - 9 Lacs
hyderabad
Work from Office
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...
Posted 2 weeks ago
1.0 - 5.0 years
0 Lacs
karnataka
On-site
As an NCLEX Registered Nurse at our organization in Mangalore, you will play a crucial role in ensuring the delivery of high-quality healthcare services and benefits to our members. Your clinical experience will be utilized to collaborate effectively with a multidisciplinary team. Your main responsibilities will include conducting medical reviews to assess claims for medical necessity and contract interpretation, analyzing authorization requests for medical appropriateness, and engaging in communication with physicians, members, and providers by responding to queries and preparing necessary documentation. To qualify for this role, you must hold a BSc/MSc in Nursing with NCLEX certification a...
Posted 2 weeks ago
1.0 - 3.0 years
0 Lacs
mumbai, maharashtra, india
On-site
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...
Posted 2 weeks ago
3.0 - 7.0 years
0 Lacs
noida, uttar pradesh
On-site
As a Medical Reviewer in the Pharmacovigilance Department, you will be responsible for managing your daily workload under the guidance of the Manager. This includes individual case processing, conducting literature searches, generating aggregate reports, and completing any other tasks relevant to the department. Your role will involve medical review of Individual Case Safety Reports (ICSRs) in the Pharmacovigilance database, as well as preparing aggregate reports for expedited or periodic submissions in compliance with regulations and Standard Operating Procedures (SOPs). You will be expected to ensure compliance with the Company's SOPs and regulatory requirements, and provide support in sig...
Posted 1 month ago
2.0 - 7.0 years
0 - 0 Lacs
bangalore, hyderabad
On-site
For interview- Pratham Sharma - 9509022159 Nirbhay Verma - 9057502014 Profile - Medical Coder Location - Bengaluru/ Hyderabad Speciality Required - E/M & Surgery Job Description - A medical Coder will be primarily responsible for accurately assigning standardized codes to patient information, such as diagnoses and procedures, using classification systems like ICD-10-CM and ICD-10-PCS. 1. Assigning Codes 2. Abstracting Information 3. Maintaining Knowledge 4. Ensuring Accuracy and Quality
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
hyderabad, telangana
On-site
You will be responsible for providing support for medical safety management within the Patient Safety & Pharmacovigilance department. This includes conducting medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co-authoring safety documents, and assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority queries. Your role will involve creating quality deliverables within agreed timeframes and maintaining a high standard of accuracy in compliance with patient safety business rules, standard operating procedures, and global and local regulatory requirements. Additionally, you will be supporting in definin...
Posted 1 month ago
1.0 - 6.0 years
10 - 20 Lacs
Gandhinagar, Mumbai (All Areas)
Work from Office
*Greetings From You & I Consulting ! You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India. *Hurry Do Not Miss This Opportunity To Work For Global Giant MNC. We are hiring for the below locations under Medical Reviewer Role!! *Open Locations :- * Gandhinagar / Mumbai *Mode Of Interview - Virtual *Mode Of Work :- Work From Office * CTC Upto - 10 To 24Lpa *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) or email your CV to puja@careersuni.com PFB Job Insights for Medical Reviewer Role!! Author a CCC for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directl...
Posted 2 months ago
0.0 - 1.0 years
1 - 2 Lacs
Bengaluru
Work from Office
Roles and Responsibility Conduct thorough medical reviews of patient records, including diagnoses, treatments, and test results. Analyze medical information to identify trends, patterns, and areas for improvement. Collaborate with healthcare professionals to develop and implement effective treatment plans. Maintain accurate and up-to-date records of patient information and review findings. Participate in quality improvement initiatives to enhance the quality of medical care. Develop and maintain knowledge of medical terminology, regulations, and standards. Job Requirements Strong understanding of medical terminology, anatomy, and physiology. Excellent analytical, communication, and problem-s...
Posted 3 months ago
4.0 - 8.0 years
15 - 20 Lacs
Ahmedabad
Remote
The Clinical Trial Physician is responsible for providing medical input within the organization as well as to external partners and performing medical review tasks within the context of clinical trials. Furthermore, the Clinical Trial Physician is responsible for undertaking scientific/medical writing tasks within the organization. Role & responsibilities Is responsible for the development of: All study related documents that fall under the Clinical Science Department scope (e.g., Study Protocols, ICFs - in collaboration with other departments e.g., Clinical Operations, Regulatory, as required -, Pharmacy Manuals, Medical Review Plans, etc.), Scientific presentations and manuscripts, Medical...
Posted 3 months ago
1.0 - 6.0 years
10 - 20 Lacs
Pune, Chennai, Mumbai (All Areas)
Work from Office
*Greetings From You & I Consulting ! You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India. *Hurry Do Not Miss This Opportunity To Work For Global Giant MNC. We are hiring for the below locations under Medical Reviewer Role!! *Open Locations :- * Pune/ / Chennai / Mumbai *Mode Of Interview - Virtual *Mode Of Work :- Work From Office * CTC Upto - 10 To 24Lpa *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) or email your CV to puja@careersuni.com PFB Job Insights for Medical Reviewer Role!! Author a CCC for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, dir...
Posted 3 months ago
7.0 - 12.0 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi We are looking to hire Medical Data Reviewer for our Client. Please go through the JD and Apply. Responsibilities: Review subject/ patient level data for accuracy, to identify any anomalies, trends in patient reported data Review and provide inputs ion design of eCRF Review investigation product dosing Review all reported Adverse Events (AEs), Concomitant Medication and medical Ensure that any out of range data/ anomaly is verified Review all laboratory data on study subjects Review data in the form of visualizations and identify potential issues of concern Training new team members Qualifications: Bachelor/ Masters degree or equivalent in Life sciences/ Alternative Medicine (preferred) E...
Posted 3 months ago
1.0 - 6.0 years
10 - 20 Lacs
Pune, Bangalore Rural, Mumbai (All Areas)
Work from Office
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...
Posted 3 months ago
1.0 - 6.0 years
10 - 20 Lacs
Gandhinagar, Nagpur, Bengaluru
Work from Office
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...
Posted 3 months ago
4.0 - 9.0 years
11 - 21 Lacs
Nagpur, Pune, Mumbai (All Areas)
Work from Office
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...
Posted 3 months ago
10 - 12 years
32 - 35 Lacs
Pune
Remote
CLINIMINDS IS RECRUITING THIS POSITON FOR THE THE US BASED GLOBAL PHARMA CONSULTING AND PHARMACOVIGILANCE FIRM Role & responsibilities The Associate Director will lead the medical evaluation of Individual Case Safety Reports (ICSRs), oversee the clinical review of aggregate safety reports (e.g., PBRERs, DSURs, ACOs), and provide strategic and medical input in signal detection and benefit-risk assessments for the companys product portfolio, including biosimilars. The role ensures compliance with global regulatory requirements and drives excellence in pharmacovigilance science. ICSR Medical Review Aggregate Report Review Signal Management Cross-functional Collaboration Preferred candidate prof...
Posted 4 months ago
1 - 6 years
10 - 20 Lacs
Pune, Bangalore Rural, Mumbai (All Areas)
Work from Office
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...
Posted 4 months ago
1 - 6 years
10 - 20 Lacs
Gandhinagar, Nagpur, Bengaluru
Work from Office
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...
Posted 4 months ago
4 - 9 years
11 - 21 Lacs
Nagpur, Pune, Mumbai (All Areas)
Work from Office
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...
Posted 4 months ago
1 - 6 years
10 - 20 Lacs
Pune, Bangalore Rural, Mumbai (All Areas)
Work from Office
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...
Posted 4 months ago
4 - 9 years
11 - 21 Lacs
Nagpur, Pune, Mumbai (All Areas)
Work from Office
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...
Posted 4 months ago
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