410 Drug Safety Jobs - Page 5

We are currently looking for Medical Oncologist with strong experienced in Medical Oncology with an entrepreneur mindset prepared to work in a collaborative Team as our Internal Team member / Partner/ External Partner / having busy Medical Oncology Practices handled atleast 100-10000's of Cancer Patients ( In top 20 Cancers) in his experience with a reputed Medical Research University & Hospital or in a startup /mid-size company/ MNC / Top Onco Pharma MNC. Qualification : 1) MBBS with DNB / MD /MS/Mch with specialization in medical Oncology practice or Medical Oncology Research/Onco Surgeon from reputed Medical University & Hospital. Experience : 5 - 25 Years experience in medical Oncology Practice or Cancer Medical Research Post MBBS, MD /MS OR Post MSc, PhD in Medical Oncology by Research from Reputed Medical Research University needs to apply. - Eligible Professional may apply to this job opportunity along with CV with passport size photo, your medical Practice / Research area, current & expected CTC, Notice period and Medical Practice / Research Projects details.

We are currently looking for Medical Oncologist with strong experienced in Medical Oncology with an entrepreneur mindset prepared to work in a collaborative Team as our Internal Team member / Partner/ External Partner / having busy Medical Oncology Practices handled atleast 100-10000's of Cancer Patients ( In top 20 Cancers) in his experience with a reputed Medical Research University & Hospital or in a startup /mid-size company/ MNC / Top Onco Pharma MNC. Qualification : 1) MBBS with DNB / MD /MS/Mch with specialization in medical Oncology practice or Medical Oncology Research/Onco Surgeon from reputed Medical University & Hospital. Experience : 5 - 25 Years experience in medical Oncology Practice or Cancer Medical Research Post MBBS, MD /MS OR Post MSc, PhD in Medical Oncology by Research from Reputed Medical Research University needs to apply. - Eligible Professional may apply to this job opportunity along with CV with passport size photo, your medical Practice / Research area, current & expected CTC, Notice period and Medical Practice / Research Projects details.

We are currently looking for Medical Oncologist with strong experienced in Medical Oncology with an entrepreneur mindset prepared to work in a collaborative Team as our Internal Team member / Partner/ External Partner / having busy Medical Oncology Practices handled atleast 100-10000's of Cancer Patients ( In top 20 Cancers) in his experience with a reputed Medical Research University & Hospital or in a startup /mid-size company/ MNC / Top Onco Pharma MNC. Qualification : 1) MBBS with DNB / MD /MS/Mch with specialization in medical Oncology practice or Medical Oncology Research/Onco Surgeon from reputed Medical University & Hospital. Experience : 5 - 25 Years experience in medical Oncology Practice or Cancer Medical Research Post MBBS, MD /MS OR Post MSc, PhD in Medical Oncology by Research from Reputed Medical Research University needs to apply. - Eligible Professional may apply to this job opportunity along with CV with passport size photo, your medical Practice / Research area, current & expected CTC, Notice period and Medical Practice / Research Projects details.

We are currently looking for Medical Oncologist with strong experienced in Medical Oncology with an entrepreneur mindset prepared to work in a collaborative Team as our Internal Team member / Partner/ External Partner / having busy Medical Oncology Practices handled atleast 100-10000's of Cancer Patients ( In top 20 Cancers) in his experience with a reputed Medical Research University & Hospital. Qualification : 1) MBBS with DNB / MD /MS/Mch with specialization in medical Oncology or Medical Oncology Research / Onco Surgery / Radiation Oncology / Hemato Oncology from reputed Medical University & Hospital. Experience : 5 - 30 Years experience in medical Oncology Practice or Cancer Medical Research Post MBBS, MD /MS / Mch from Reputed Medical Research University & Hospital needs to apply. - Eligible Professional may apply to this job opportunity along with CV with passport size photo, your medical Practice / Research area.

We are currently looking for Medical Oncologist with strong experienced in Medical Oncology with an entrepreneur mindset prepared to work in a collaborative Team as our Internal Team member / Partner/ External Partner / having busy Medical Oncology Practices handled atleast 100-10000's of Cancer Patients ( In top 20 Cancers) in his experience with a reputed Medical Research University & Hospital. Qualification : 1) MBBS with DNB / MD /MS/Mch with specialization in medical Oncology or Medical Oncology Research / Onco Surgery / Radiation Oncology / Hemato Oncology from reputed Medical University & Hospital. Experience : 5 - 30 Years experience in medical Oncology Practice or Cancer Medical Research Post MBBS, MD /MS / Mch from Reputed Medical Research University & Hospital needs to apply. - Eligible Professional may apply to this job opportunity along with CV with passport size photo, your medical Practice / Research area.

We are currently looking for Medical Oncologist with strong experienced in Medical Oncology with an entrepreneur mindset prepared to work in a collaborative Team as our Internal Team member / Partner/ External Partner / having busy Medical Oncology Practices handled atleast 100-10000's of Cancer Patients ( In top 20 Cancers) in his experience with a reputed Medical Research University & Hospital. Qualification : 1) MBBS with DNB / MD /MS/Mch with specialization in medical Oncology or Medical Oncology Research / Onco Surgery / Radiation Oncology / Hemato Oncology from reputed Medical University & Hospital. Experience : 5 - 30 Years experience in medical Oncology Practice or Cancer Medical Research Post MBBS, MD /MS / Mch from Reputed Medical Research University & Hospital needs to apply. - Eligible Professional may apply to this job opportunity along with CV with passport size photo, your medical Practice / Research area.

We are currently looking for Medical Oncologist with strong experienced in Medical Oncology with an entrepreneur mindset prepared to work in a collaborative Team as our Internal Team member / Partner/ External Partner / having busy Medical Oncology Practices handled atleast 100-10000's of Cancer Patients ( In top 20 Cancers) in his experience with a reputed Medical Research University & Hospital. Qualification : 1) MBBS with DNB / MD /MS/Mch with specialization in medical Oncology or Medical Oncology Research / Onco Surgery / Radiation Oncology / Hemato Oncology from reputed Medical University & Hospital. Experience : 5 - 30 Years experience in medical Oncology Practice or Cancer Medical Research Post MBBS, MD /MS / Mch from Reputed Medical Research University & Hospital needs to apply. - Eligible Professional may apply to this job opportunity along with CV with passport size photo, your medical Practice / Research area.

We are currently looking for Medical Oncologist with strong experienced in Medical Oncology with an entrepreneur mindset prepared to work in a collaborative Team as our Internal Team member / Partner/ External Partner / having busy Medical Oncology Practices handled atleast 100-10000's of Cancer Patients ( In top 20 Cancers) in his experience with a reputed Medical Research University & Hospital. Qualification : 1) MBBS with DNB / MD /MS/Mch with specialization in medical Oncology or Medical Oncology Research / Onco Surgery / Radiation Oncology / Hemato Oncology from reputed Medical University & Hospital. Experience : 5 - 30 Years experience in medical Oncology Practice or Cancer Medical Research Post MBBS, MD /MS / Mch from Reputed Medical Research University & Hospital needs to apply. - Eligible Professional may apply to this job opportunity along with CV with passport size photo, your medical Practice / Research area.

We are currently looking for Medical Oncologist with strong experienced in Medical Oncology with an entrepreneur mindset prepared to work in a collaborative Team as our Internal Team member / Partner/ External Partner / having busy Medical Oncology Practices handled atleast 100-10000's of Cancer Patients ( In top 20 Cancers) in his experience with a reputed Medical Research University & Hospital. Qualification : 1) MBBS with DNB / MD /MS/Mch with specialization in medical Oncology or Medical Oncology Research / Onco Surgery / Radiation Oncology / Hemato Oncology from reputed Medical University & Hospital. Experience : 5 - 30 Years experience in medical Oncology Practice or Cancer Medical Research Post MBBS, MD /MS / Mch from Reputed Medical Research University & Hospital needs to apply. - Eligible Professional may apply to this job opportunity along with CV with passport size photo, your medical Practice / Research area.

We are currently looking for Medical Oncologist with strong experienced in Medical Oncology with an entrepreneur mindset prepared to work in a collaborative Team as our Internal Team member / Partner/ External Partner / having busy Medical Oncology Practices handled atleast 100-10000's of Cancer Patients ( In top 20 Cancers) in his experience with a reputed Medical Research University & Hospital. Qualification : 1) MBBS with DNB / MD /MS/Mch with specialization in medical Oncology or Medical Oncology Research / Onco Surgery / Radiation Oncology / Hemato Oncology from reputed Medical University & Hospital. Experience : 5 - 30 Years experience in medical Oncology Practice or Cancer Medical Research Post MBBS, MD /MS / Mch from Reputed Medical Research University & Hospital needs to apply. - Eligible Professional may apply to this job opportunity along with CV with passport size photo, your medical Practice / Research area.

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 stand alone 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) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product s safety profile Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Represent safety and clinical data review findings during client meetings Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies Provide medical oversight for label development, review and change Provide medical support and attendance at Data Safety Monitoring Board Meetings Attends and contributes medical safety evaluation on Safety Monitoring Committees Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture. Act as Global Safety Physician or Assistant or Back-up on projects as assigned Attend project meetings, medical safety team meetings, and client meetings as requested Ensure coverage for all medical safety deliverables within regulatory or contracted timelines Provide medical escalation support for medical information projects Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects 24 hour medical support as required on assigned projects Maintain awareness of medical-safety-regulatory industry developments Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req Three (3) years of clinical practice experience (e.g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training and experience Req Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice Knowledge of clinical trials and pharmaceutical research process Ability to establish and meet priorities, deadlines, and objectives. Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref

Skill required: Pharmacovigilance Services - Safety Writing Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 5 to 8 years About Accenture 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. 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 worlds 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. What are we looking for Ability to establish strong client relationship Roles and Responsibilities: oPrepare and review Aggregate reports and any adhoc reports requested by Client.oConduct or attend and contribute, as applicable, to a kick-off meeting and regular teleconferences with the Client during the preparation of Aggregate reports.oComplete all the sections of Aggregate Reports as per Client SOPs and guidelines and as agreed during kick-off meeting.oLiaise with relevant internal and Client stakeholders for the inputs required for the Aggregate Reports.oCoordinate data cleaning process (missing data clearance and send request for stop/ resume book in of cases) prior to final listings generation.oPerform activities as lead author and prepare submission ready draft for Aggregate reports.oPerform QC of the assigned draft Aggregate reports, per scorecard agreed with Client, and provide feedback to the responsible author with the duly filled scorecard defect tracker.oReview source documentation provided by Client for completeness and accuracy.oFacilitate stakeholders review as defined by the Client.oShall address all the comments received from all the stakeholders including review comments and provide the respective final versions of the reports to the Client ready for publishing.oOn-time escalation of any delayed inputs. Qualification Bachelor of Pharmacy

Aster Medcity is looking for Senior Clinical Pharmacist. Clinical Pharmacy.Aster MIMS Kannur to join our dynamic team and embark on a rewarding career journey Compounding and dispensing medications, as prescribed by physicians. Monitoring customers drug therapies, advising interventions, and informing customers of any potential side effects. Instructing customers on how and when to take prescribed medications. Conducting health and wellness screenings. Providing immunizations, and other medical services, such as taking blood pressure, temperature measurements, and checking blood sugar levels. Keeping accurate customer records. Ensuring a safe and clean working environment. Completing operational requirements of the pharmacy, including verifying order entries, maintaining records of controlled substances, charges, and removing expired and/or damaged drugs from the pharmacys inventory. Adhering to applicable legal rules, regulations, and procedures governing pharmaceutical practice. Performing other administrative tasks when needed.

The role of the Medical Office is to bring medical, regulatory, scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: global regulatory affairs, global medical affairs, global healthcare compliance, global patient safety and global clinical development. This entails engaging and collaborating with regulatory agencies, healthcare organizations, healthcare professionals and customers both internal and external - and generating and communicating relevant, meaningful, and impactful data, and securing and maintaining marketing authorizations across the ADVANZ PHARMA portfolio. In so doing, the Medical Office represents the voice of the patient in all matters; works to ensure that products and marketing authorizations are supported by relevant, up to date data and retain a positive benefit/risk profile; helps to drive our scientific credibility and reputation as a company; enables stakeholders to make informed choices for patients; operates with due regard to all relevant regulations and compliance requirements. About the Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for Specialist Regulatory Affairs LCM Strategic Growth Products. Main purpose of the job is to ensure adequate and prompt life cycle maintenance activities for Marketing Authorization s (MA) held by ADVANZ PHARMA based on portfolio assigned with a focus on supply continuity and compliance with regulatory requirements. Provide supportive role to New Product Introduction team during Translation and Product label/mock up finalization to secure necessary approvals. In case of DCPs, responsible for managing the national phase procedure with respective health authorities. Become the primary point of contact for Health Authorities following grant of Marketing Authorisation; as we'll become the single point of contact for the organization. This role will shadow the New Products Introduction Manager (Product Lead) to seek necessary knowledge of the new MA procedure and all the HA interactions that occurs during this procedure with an intent to identify specific negotiations, key commitments made and also identify potential post approval activities that might be necessary to either support a product launch or maintain continuity of supplies. This role will start working with NPI function, necessary stakeholders internal (such as Quality, Supply Chain, Technical, Medical or Commercial) and external (such as developer) to plan, strategize and execute all necessary post approval activities which will include but not limited to the following: Renewal Application and Annual Maintenance Variation Application Notification of Change in Marketing Status, sunset clause exemptions where applicable Notification of drug shortages Tracking and fulfillment of regulatory commitments made including any Specific Obligations for Conditionally /Exceptionally approved products. PIP Modifications, PIP compliance and associated label update Orphan Designation Maintenance (where applicable) Updation of NBO technical package (where applicable) This role will be assigned specific molecules, Primarily Innovative Medicines (but may as we'll extend other categories) and will become the LCM product lead for the assigned molecules globally, in all markets where there are registrations/Marketing Authorization available. This role will be expected to maintain and discuss/align Regulatory submission Plan, Regulatory Post Approval Strategy with cross functional teams. This role will be nominated to be involved being part of cross functional meetings such as Change Control Meeting, SNOP meeting etc for their assigned molecules. This role will be supported by Subject Matter Experts from the New Products Team (for Biosimilars and Specialty Generic Products) and Innovative Medicines team (for NCE and Biologics) for strategy formation and review. This role hence should be able to collaborate and work very closely with these functions throughout the life cycle of the products. This role will also contribute to the preparation of meeting packages for Scientific Advice, as and when needed and drive readiness preparation and participate in scientific advice as may be necessary to determine any post approval regulatory strategy. This role will support any market expansion activity by either driving or supporting a new product application of assigned molecules (already approved in EU, UK) to newer territories. This will be decided on a case-by-case basis. This role will be also responsible for maintaining Hand over document that would be used for further transition of responsibilities to LCM Established Products at a later stage for Innovative Medicines and Specialty Generic Products. While, ideally responsibilities of any approved products acquired through M&A will not sit with this role, howe'ver, depending on the nature of the products acquired, this role may be involved and become responsible for due diligence and integration. For example, any asset which is a Conditional Marketing Authorisation or has an Exceptional Circumstances status at the time of acquisition, would best sit with the LCM Strategic Growth team. Actively participate in continuous improvement initiatives, share ideas and thoughts, actively involve in implementation of such initiatives. Act as process owner for some regulatory procedures as and when delegated. Support line managers for readiness of any health authority inspection as and when delegated. Ensure timely completion of assigned Deviation and CAPAs. We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Graduate or post-graduate in any discipline of Science, preferably life science / Pharmacy. Knowledge, Skills & Experience: Significant experience of handling life cycle management of pharmaceuticals in EU/UK and other regulated markets (such as Canada, Australia and New Zealand) as an individual contributor. Good understanding of ICH Clinical and Safety guidelines should be able to interpret guidelines and apply them in practical situations independently we'll versed with EU/UK Regulatory procedures and processes. Good understanding and hands on experience of working on CTD. Experience interacting with EU/UK regulatory authorities Scientific advice meetings/ Pre-submission meetings. Experience of handling Innovative Medicines post approval changes such as PIP modifications and label expansions. Hands on experience of document management and change control management systems. Strong Project Management and Communication skills. Pleasant personality with collaborative approach, strategic mindset & Positive attitude. Demonstrate sense of drive and urgency through work. Be able to take decisions based on facts available, trend and suggest solutions to line manager (solution oriented). Excellent communication skills verbal and written; Ability to present to senior stakeholders confidently Ability to work under pressure and flexibility to adapt to evolving business situation. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment.

Their responsibilities include reviewing safety data, identifying potential safety signals, assessing causality, and providing guidance on risk management and communication. Key Responsibilities: Safety Data Review and Analysis Risk Management and Communication Regulatory Compliance Qualifications Bachelor's or Masters degree in a related field, such as Medicine, pharmacy or related field 0-2 years of experience in related field Strong analytical and problem-solving skills Excellent communication and interpersonal skills Ability to work independently and as part of a team Interested to apply can share CV or call/whatsapp to 9342735755

Clinztech is looking for Clinical Data Analyst I to join our dynamic team and embark on a rewarding career journey. Managing master data, including creation, updates, and deletion. Managing users and user roles. Provide quality assurance of imported data, working with quality assurance analysts if necessary. Commissioning and decommissioning of data sets. Processing confidential data and information according to guidelines. Helping develop reports and analysis. Managing and designing the reporting environment, including data sources, security, and metadata. Supporting the data warehouse in identifying and revising reporting requirements. Supporting initiatives for data integrity and normalization. Assessing tests and implementing new or upgraded software and assisting with strategic decisions on new systems. Generating reports from single or multiple systems. Troubleshooting the reporting database environment and reports. Evaluating changes and updates to source production systems. Training end - users on new reports and dashboards. Providing technical expertise in data storage structures, data mining, and data cleansing.

Clinztech is looking for Clinical Research Coordinator II to join our dynamic team and embark on a rewarding career journey. Coordinate clinical research activities. Ensure compliance with study protocols and regulations. Recruit and screen study participants. Collect and manage clinical data. Prepare and submit regulatory documents. Monitor study progress and report findings. Liaise with research teams and sponsors.

Clinztech is looking for Pharmacovigilance Associate I to join our dynamic team and embark on a rewarding career journey. Monitor and assess the safety of pharmaceutical products through the collection and analysis of adverse event reports. Ensure compliance with regulatory requirements related to pharmacovigilance. Prepare and submit reports to regulatory authorities regarding product safety. Collaborate with internal teams to develop risk management strategies for pharmaceutical products. Provide training and guidance to staff on pharmacovigilance practices and policies. Maintain up - to - date knowledge of industry trends and regulatory changes.

*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, 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. 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 * * *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com ***Note we also have open positions for the below skills :- *Aggregate Reporting / Clinical Data Management / Clinical SAS / SQL Programmer / EDC Programmer / Medical Monitor / HEOR Health Economist Role / SAS + R / Statistical Programmer / Study Data Manager *Though We Try and Answer The Calls Immediately, but Due to Heavy Call Flow The Below Numbers Might Be Busy At Times. In case you find the number busy, please whatsapp your details to us in the below format: - Name- Mobile number - Mail - Qualification - Total work experience - Current Organization- Location - Last CTC Expected CTC:- *Interested candidates can even refer their friends or relatives provided the criteria *FOR interview Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com

Job Title: Senior Medical Safety Advisor Education Qualification: MBBS/MD. Work Location: Anywhere in India. Work Mode: Home Based. Years of exp: 3yrs Clinical and 2+ yrs of PV (Exp in Oncology is a must) 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) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a products safety profile Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Represent safety and clinical data review findings during client meetings Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies Provide medical oversight for label development, review and change Provide medical support and attendance at Data Safety Monitoring Board Meetings • Attends and contributes medical safety evaluation on Safety Monitoring Committees Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture. Act as Global Safety Physician or Assistant or Back-up on projects as assigned Attend project meetings, medical safety team meetings, and client meetings as requested Ensure coverages for all medical safety deliverables within regulatory or contracted timelines Provide medical escalation support for medical information projects Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects • 24-hour medical support as required on assigned projects Maintain awareness of medical-safety-regulatory industry developments Qualifications Required MBBS/MD graduates from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. Three (3) years of clinical practice experience with 2+ additional years in the pharmaceutical or associated industry in any role is required. Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice. Knowledge of clinical trials and pharmaceutical research process. Ability to establish and meet priorities, deadlines, and objectives. Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility. Ability to establish and maintain effective working relationships with coworkers, managers and clients. A valid medical license, or equivalent, from the country or region in which he/she resides and works Preferred.

The job involves performing sampling, analysis, and reporting of raw materials, intermediates, in-process samples, finished products, and stability samples. It is essential to maintain accurate and complete records of all quality control (QC) activities. As part of the role, you will be responsible for ensuring the safety, efficacy, and quality of drugs by conducting tests, analyzing data, maintaining records, and ensuring compliance with regulations and standards. This is a full-time position with benefits such as food provided and a yearly bonus. The work location is in person.,

As a PSUR Specialist, your primary responsibility will be to author and review Periodic Safety Update Reports (PSURs/PBRERs) for submission to health authorities. You will play a crucial role in ensuring the accuracy, completeness, and regulatory compliance of all PSURs. Additionally, you will be tasked with performing literature searches to gather relevant data for PSUR preparation and validating the information obtained to ensure accuracy. Your role will involve extracting and validating data from various sources, including Reference Safety Information (RSI), sales data, previous reports, and Risk Management Plans (RMP). You will also be responsible for generating Line Listings (LL) from the safety database for inclusion in PSURs. Effective process management is key, as you will need to manage and reconcile relevant process trackers to ensure all activities are documented and on schedule. Providing reliable support for high-priority ad-hoc activities related to PSUR preparation will also be part of your daily tasks. Client interaction is an important aspect of this role, as you will communicate with client personnel to resolve issues related to PSURs, ensuring adherence to client policies. It will be your responsibility to ensure that PSUR deliverables comply with regulatory requirements and are submitted within agreed timelines. Furthermore, you will serve as a subject matter expert (SME) for PSUR preparation and review, providing training and mentoring to team members on PSUR-related processes and regulatory requirements. To excel in this role, you should hold a Bachelor's degree in a relevant scientific or medical field, with an advanced degree being preferred. Previous experience in pharmacovigilance, drug safety, or a related field, with a focus on PSUR preparation and review, is essential. Knowledge of regulatory requirements for PSURs/PBRERs, strong analytical and problem-solving skills, excellent written and verbal communication skills, proficiency in safety databases and data extraction/validation processes, as well as strong organizational skills are key qualifications needed for this position. Demonstrated ability to collaborate effectively with cross-functional teams and provide expert support will be critical for success in this role.,

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

As an Echo Technician at Manipal Hospitals, you will be responsible for performing echocardiograms and assisting in diagnosing cardiac conditions. You will work under the supervision of cardiologists and other healthcare professionals to obtain high-quality images of the heart. Your duties will include ensuring patient comfort, preparing patients for echocardiogram procedures, and operating ultrasound equipment. You will also analyze and interpret echocardiographic data, maintain accurate records, and collaborate with the healthcare team to provide the best patient care. Key Responsibilities: - Perform transthoracic and transesophageal echocardiograms as per standard protocols. - Prepare patients for procedures and explain the process to alleviate any concerns. - Assist in the diagnosis of cardiac conditions by providing accurate and clear ultrasound images. - Maintain and calibrate ultrasound equipment to ensure optimal performance. - Document and report findings to the supervising cardiologist for further evaluation. - Ensure compliance with hospital policies and healthcare regulations. - Participate in departmental meetings and professional development activities. - Provide support during stress echocardiograms and other specialized tests as needed. Skills and Tools Required: - Strong knowledge of echocardiographic techniques and principles. - Proficiency in operating echocardiography equipment and understanding ultrasound technology. - Excellent communication and interpersonal skills to effectively interact with patients and medical staff. - Attention to detail and strong analytical skills for interpreting echocardiography results. - Ability to work in a fast-paced environment and manage multiple tasks simultaneously. - Familiarity with electronic medical record (EMR) systems for documentation purposes. - Certification as an echocardiographer or relevant experience in a clinical setting is preferred. - Basic life support (BLS) certification and knowledge of emergency protocols. This role is ideal for a dedicated and skilled professional who is passionate about patient care and cardiac health, offering an opportunity to grow within a leading healthcare institution. Roles and Responsibilities About the Role: As an Echo Technician at Manipal Hospitals, you will play a critical role in performing echocardiograms for patients. Your expertise will aid in the assessment and diagnosis of various cardiac conditions. You will work closely with cardiologists and other healthcare professionals to ensure high standards of patient care are maintained. About the Team: You will be part of a dedicated team of healthcare professionals, including cardiologists, nurses, and imaging specialists. The team collaborates to provide comprehensive cardiac care and utilizes state-of-the-art technology for diagnostics. A supportive and learning-focused environment is fostered to enhance both personal and professional growth. You are Responsible for: - Conducting echocardiogram examinations and ensuring quality imaging. - Maintaining and calibrating echocardiography equipment to ensure optimal performance. - Documenting and reporting findings accurately to assist in patient diagnosis and treatment. - Educating patients on the procedure and addressing any concerns they may have. To succeed in this role – you should have the following: - A degree or certification in echocardiography or a related field. - Proficiency in operating echocardiography equipment and interpreting results. - Strong communication skills to interact effectively with patients and healthcare teams. - Attention to detail and a commitment to maintaining patient safety and comfort.

Greetings from Wipro!! Inviting applicant for Walk-in Drive-in Kolkata Location for Medical Device Investigator r ole Experience- 0 to 1 year Qualification- B. Pharm/ M. Pharm / Biomedical & Mechanical engineer/ BSc in Medical Imaging & Radiology Technology/master's in molecular Biology/B.SC Nursing/BDS Only the above-mentioned qualifications candidates are requested to attend the Walk in drive Current year pass out students should have original hardcopy Marksheet & Provisional Certificate Walk In Date- 12-July-25 Time to Report- 10 A.M- 1 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- Wipro Gate 2 - Plot no. 8&9 Block DM Sector V Salt Lake, Kolkata WB 700091- Near Salt Lake Sector V -Metro Station Candidate should have excellent Communication in English Should be ready for Fixed Night Shift Should have excellent knowledge of Medical Device