410 Drug Safety Jobs - Page 11

Title We are currently seeking a full-time, office-based Clinical Safety Coordinator to join our Clinical Safety department in India. This position will be focused on the handling and processing of adverse events from all sources, including clinical trials and post marketing surveillance. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Determine plan of action for incoming calls; Collect, process, and track incoming adverse and serious adverse events; Write safety narratives; Report on various safety data; and Collaborate with internal departments and investigative clinical research sites to ensure compliance with safety processes. Qualifications Bachelor's degree in Healthcare related field; Nursing, Pharmacy, Pharmacology, etc Clinical experience or Clinical Research, case processing and Post marketing Pharmacovigilance experience is preferred; Proficient English is required Proficient knowledge of Microsoft® Office; Broad knowledge of medical terminology; and Strong organizational and communication skills. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

A Hospital Pharmacist is Responsible for dispensing medications, ensuring their safety and efficacy, and providing drug information to patients and healthcare professionals. Responsibilities: Maintain stock, supplies, and inventories of all medicines. Will be responsible for the preparation of indents for the hospital Pharmacy. You will maintain the Stock Registers. Will be responsible for checking the expiry dates of drugs/medicines and arranging timely consumption or replacement thereof. Maintains a checklist and takes inventory of high alert medications/narcotics/backup pharmacy on a daily basis. The Pharmacist is responsible for monitoring the supply of all medicines used in the hospital Will be responsible for any other duties assigned by the Reporting Manager from time to time. May also be involved in drug safety monitoring and quality improvement initiatives. Skill Sets: Verbal Ability/Communication Skill Problem Solving/Decision Making Leadership Qualities Education: D Pharm OR B Pharm Freshers can also apply for this job. There is an opening for full-time as well as Part-time pharmacist.

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Deliver NoPerformance ParameterMeasure1ProcessNo. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback2Self- ManagementProductivity, efficiency, absenteeism, Training Hours, No of technical training completedMandatory Skills: Pharmacovigilance & Drug Safety(Pharma).

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Data Coder to join our Clinical Coding & Support team in Mumbai, India. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous coding, pharmacy, or nursing expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Perform accurate coding of medical terms and medications utilizing industry-wide standards as well as company standards; Coordinate the assignment of appropriate dictionaries for meeting study requirements; and Develop and maintain coding guidelines Qualifications Bachelor Degree in Nursing, or more advanced clinical degree; Experience with using MedDRA and WHO Drug dictionaries; and Experience working with clinical trials or within the pharmaceutical environment is preferred. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Data Review Associate in Mumbai, India to join our Global Clinical Coding & Support team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous nursing expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Comprehensive manual review of clinical data collected in trials Development of clinical review guidelines for specific therapeutic areas Interface with Data Management team to assure query resolution Seeking specialization in following therapeutic areas: Oncology Hematology Infectious Disease Endocrinology Metabolic disorders Qualifications Bachelor’s Degree in Nursing / Medicine, or more advanced clinical degree Professional / or Post-Qualification Nursing experience, preferably in Oncology and Hematology background General knowledge of clinical trial processes and/or experience working with clinical data Experience with using MedDRA and WHO Drug dictionaries will be a plus. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Responsibilities: Review protocol and provide suggestions Respond to queries/ clarifications from EC/ IRBs Answer medical questions from sites or project team Respond to queries from sites with regard to protocol Attend drug safety meetings/ external meetings Patient eligibility review Review AE/ SAEs Protocol training to site staff, CRAs etc Attend, participate/ present in investigator meetings Qualification: MBBS/ MD qualification Eligibility: 3 year+ of clinical trial experience Familiar with clinical trials operations Good English communication skills Proficiency in using Microsoft office

Job Title: Pharmacist Company Name: Manipal Hospitals Job Description: Manipal Hospitals is seeking a dedicated and knowledgeable Pharmacist to join our healthcare team. The ideal candidate will be responsible for ensuring the safe and effective use of medications for our patients. Roles and Responsibilities Roles and Responsibilities: 1. Dispense medications and ensure the accuracy of prescriptions provided by healthcare professionals. 2. Counsel patients on the proper use of medications, potential side effects, and drug interactions. 3. Collaborate with doctors, nurses, and other healthcare staff to optimize patient care and medication management. 4. Conduct medication reviews and maintain patient medication profiles to ensure safe and effective therapy. 5. Monitor and manage the inventory of pharmaceuticals, ensuring adequate stock levels and proper storage conditions. 6. Provide drug information and education to both patients and healthcare professionals. 7. Participate in quality improvement initiatives and adhere to regulatory standards and hospital policies. 8. Maintain accurate and detailed records of all pharmacy activities, including prescriptions dispensed and medication errors. 9. Supervise pharmacy technicians and support staff in their daily tasks and responsibilities. 10. Stay updated on new medications and treatment protocols, continuing professional development. Qualifications: - Bachelor's degree in Pharmacy or Pharm.D. from an accredited institution. - Valid pharmacist license in the respective state. - Strong knowledge of pharmacology and pharmaceutical care practices

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Physiotheraphy Years of Experience: 0 to 1 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.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Junior Drug Safety AssociateJunior Drug Safety Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Physiotheraphy

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Deliver NoPerformance ParameterMeasure1ProcessNo. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback2Self- ManagementProductivity, efficiency, absenteeism, Training Hours, No of technical training completed Mandatory Skills: Pharmacovigilance & Drug Safety(Pharma).

KASHI INSTITUTE OF TECHNOLOGY is looking for Senior Research Assistant (SRA) / Research Assistant ( RA) to join our dynamic team and embark on a rewarding career journey Conduct Research: Design and execute experiments or research projects under the guidance of senior researchers or project leaders. Collect, analyze, and interpret data using various research methodologies and tools. Literature Review: Review relevant literature to understand the current state of knowledge in the research area. Stay updated on advancements in the field and incorporate relevant findings into ongoing research. Data Collection and Analysis: Utilize appropriate techniques to gather data, whether through experiments, surveys, interviews, or other methods. Analyze and interpret data using statistical methods or other relevant analytical approaches. Report Writing: Prepare detailed reports summarizing research findings, methodologies, and conclusions. Contribute to the writing of research papers, articles, and presentations for conferences or publications. Collaboration: Work closely with team members, senior researchers, and other stakeholders to achieve research goals. Participate in research meetings, seminars, and conferences. Equipment and Lab Maintenance: Maintain and operate laboratory equipment as needed. Ensure proper documentation and organization of research materials. Compliance and Ethics: Adhere to ethical guidelines and standards in research activities. Ensure compliance with relevant regulations and protocols.

Looks Studio is looking for Doctor to join our dynamic team and embark on a rewarding career journey Patient Consultations: Conduct thorough consultations with patients to understand their goals, concerns, and medical histories, and provide expert recommendations for appropriate surgical or non-surgical interventions. Surgical Procedures: Perform a variety of plastic and cosmetic surgical procedures, such as breast augmentation, liposuction, rhinoplasty, facelifts, tummy tucks, and reconstructive surgeries. Preoperative Assessments: Evaluate patients' physical and mental suitability for surgery, order necessary preoperative tests, and educate patients on preoperative and postoperative care. Treatment Plans: Develop individualized treatment plans tailored to each patient's unique needs and desired outcomes, explaining risks, benefits, and potential outcomes. Surgical Techniques: Utilize advanced surgical techniques, technology, and tools to achieve optimal results while ensuring patient safety and minimizing risks. Non-Surgical Procedures: Offer and perform non-surgical cosmetic procedures such as Botox injections, dermal fillers, laser treatments, and chemical peels. Postoperative Care: Provide postoperative care, follow-up appointments, and ongoing support to ensure patients' smooth recovery and satisfactory results. Qualification: MDS-OMFS Experience: Well experienced in the field of cosmetic surgery and hair transplant. Freshers who are hard working, dedicated an

We are looking for a highly skilled and experienced Branch Receivable Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-5 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the daily operations of the branch's receivables. Develop and implement strategies to improve collection efficiency and reduce delinquencies. Collaborate with internal teams to resolve customer complaints and issues related to payments. Analyze financial data to identify trends and areas for improvement in the bank's receivables. Ensure compliance with regulatory requirements and company policies. Maintain accurate records and reports of all transactions and interactions with customers. Job Requirements Strong knowledge of banking regulations and laws. Excellent communication and interpersonal skills. Ability to work effectively in a fast-paced environment and meet deadlines. Proficient in using computer software applications and systems. Strong analytical and problem-solving skills. Ability to maintain confidentiality and handle sensitive information. Experience working in a similar role within the BFSI industry is preferred.

We are looking for a skilled Branch Receivable Manager to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 5-10 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the branch's receivable portfolio, ensuring timely payments and minimizing bad debts. Develop and implement strategies to improve cash flow and reduce receivables. Collaborate with cross-functional teams to resolve customer complaints and issues. Analyze financial data to identify trends and areas for improvement in receivables management. Ensure compliance with regulatory requirements and internal policies related to receivables. Lead and motivate a team of professionals to achieve business objectives. Job Requirements Strong knowledge of accounting principles, financial regulations, and banking practices. Excellent communication, leadership, and problem-solving skills. Ability to work in a fast-paced environment and meet deadlines. Proficiency in financial software and systems. Strong analytical and decision-making skills. Experience in managing and motivating a team of professionals.

Safety Sciences Lead What you will do Group Purpose The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the robust safety strategy and deliverables for each Amgen product. The group collaboratively drive excellence in patient safety by leading signal detection, management activities, and risk management practices, including Risk Evaluation and Mitigation Strategies (REMS). Through the definition and implementation of innovative policies, research initiatives, and best practices in safety science, the teams ensure comprehensive benefit-risk assessments, effective safety communications, and adherence to quality processes supported by measurable metrics. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance with worldwide regulations. Lets do this. Lets change the world. In this vital role you will oversee all signal management activities and staff in the Safety Sciences Team at the India site, working closely with the global teams while ensuring compliance with global regulations and company standards. This role requires a strong leadership attribute with a deep understanding of drug safety and pharmacovigilance, signal detection and management, safety data analyses, risk management and people leadership/ management, along with experience in innovation and technology. This staff member will provide leadership to the Safety Sciences Team, consisting of staff based in India working across multiple therapeutic areas and signal management, while reporting into the GPS AIN Lead. Key Activities Provide direction, strategy and leadership for signal detection and management activities at the India site Provide managerial leadership to the safety sciences team allowing appropriate prioritization of resources to achieve GPS goals. Regular communication with the global team to discuss product and/or process issues. Recruit and retain talented safety professionals. Provide coaching, mentoring, and development of staff Ensure staff are compliant with Amgen corporate and departmental training Disseminate relevant information to teams as appropriate Ensures smooth and collaborative interactions with all other Safety groups Provides relevant input on technical processes in the department and contributes to continuous improvement initiatives across GPS Accountable for delivery against goals assigned to group Participate in budget and headcount planning Establish effective, collaborative interfaces with partners outside of GPS e.g. tech to ensure GPS needs are being met with respect to signal management Lead or contribute to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to signal management Qualifications: Medical degree and 6 years of directly related experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments. Minimum of 6 years of experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments. A minimum of 3 years of functional management experience overseeing PV staff A thorough understanding of the global PV regulatory environment with working knowledge of EU and US regulations, ICH guidelines, and GCP, a working understanding of drug safety databases, effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective Leadership skills and the ability to oversee multiple projects simultaneously Able to successfully manage workload to timelines Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions Familiarity with basic project management tools Ability to negotiate a strategic position after taking feedback from multiple sources Shift timings 12 PM to 9 PM IST

Associate/Sr. Associate Full-time Company Description About The Role working knowledge on Farefiling/ PRA/ CRA/ GDS/ Amadeus/Galileo platform will be an added advantage. Experience in booking reservations, cancellation of reservations, fare calculations will be added advantage. Candidate with IATA course/certification will be preferred. Candidate should be able to maintain the highest level of quality and achieving team targets as per the process specifications. IATA Freshers can apply. Experience in travel background of minimum 1 years will be added advantage Candidate should be comfortable with rotational shift including night shifts Walk in for an interview between Monday to Friday at 12.00 pm to 4.00 pm at WNS,Gate no 2,Plant 5, Vikhroli west Qualifications Any Graduate and Under Graduate Additional Information Night Shifts/Rotational Shifts Cookies Settings

Job description Bangalore, India Job category Reg Affairs & Safety Pharmacovigilance Department Global Safety - Global Business Services (GS-GBS). Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position for you. Apply now and join a growing team, working in an international environment. The Position As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the labelling for marketed products. Furthermore, perform ongoing and systematic surveillance of Novo Nordisk (NN) products during pre-approval and post-approval phases based on safety information from worldwide sources and communication of drug safety issues internally and to health authorities (HAs), as required. You will be required to establish, operate and chair the NN cross-functional safety committee throughout the lifecycle of the actual product present analysis and results of the ongoing safety surveillance at pre-defined intervals in order for the safety committee to make endorsements/recommendations. You will be responsible for all areas related to patient safety in clinical trials. You are entrusted to fulfil the following responsibilities Act as Ownerof the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for developments products. Maintenance of labelling for marketed products and participate as labelling change request (LCR) reviewer and provide safety input as LCR reviewer. As author you will prepare relevant sections of Development Safety Update Reports (DSURs), periodic Serious Unexpected Suspected Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs) and clinical Risk Management Plans (RMPs) according to implementation plans or as required by Health Authorities (HAs). Respond to requests from HAs and internally from NN affiliates. Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator s Brochure (IB), integrated safety summaries, abstracts and planned publications. You will provide proactive safety communication by participation in project/trial groups/teams established, as appropriate and conduct Investigator training as required. Provide answers to enquiries from HAs and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/ Informed Consent (ICs), establish and ensure deliverables to/from Data Monitoring Committees (DMCs). Qualifications Masters in Medicine/MD post MBBS graduate is Preferred. Relevant Experience in Signal Management, Aggregate Management, ICSR. Comfortable user of Microsoft office package (Outlook, Word, Excel, and PowerPoint). Fluent in written and spoken English. Analytical mind-set. Professional authority. Quality mind-set, well-organised and strive for excellence. Pro-active planner to meet agreed deliverables. Strong communicator (verbally and in writing). Curious and constantly looking for improvement opportunities. Team player with high degree of flexibility and service mindedness. Cross-cultural awareness. Ability and willingness to quickly adjust to changes in a continuously developing environment.

Hi Hiring for the leading ITES Company for Regulatory Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/BSc. Nursing Years of Experience: 1 to 3 years 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 world's 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.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Ability to work well in a team Adaptable and flexible Agility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy,Bachelor in Physiotherapy,BSc. Nursing

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS Years of Experience: 7 to 11 years 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 world's 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.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Agility for quick learning Adaptable and flexible Ability to work well in a team Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualifications MBBS

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS Years of Experience: 0 to 2 years 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 world's 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.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Agility for quick learning Ability to work well in a team Adaptable and flexible Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification MBBS

Our team members are at the heart of everything we'do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Main tasks: Conduct Medical Review and assessment of ICSR s into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment. Review and respond to any queries/comments from the case owner in the patient safety database. Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers. Maintain strong GPVP and GCP knowledge. Following ICH and EMA guidelines strongly and implementing them appropriately. Train and mentor PV associates on event capturing and general PV conventions as required. Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas. Escalate complex case issues on client products to Team Lead/Line Manager. Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature. Provision of scientific input in the course of literature surveillance service. Maintain good knowledge of databases, regulations, guidelines and SOP s. To actively communicate and participate in internal project meetings. Participation in internal and external audits/inspections. Review and preparation of periodic safety reports (e.g., PSURs, PBRER) and RMPs. Collaborate with Global Pharmacovigilance team with respect to Signal Detection and its processes. Perform any other drug safety related activities as assigned. . Qualification, experience skills: Degree in Medicine. PG degree in any discipline is an advantage but not mandatory. Minimum 2 years of relevant experience in Pharmacovigilance Drug Safety. Strong interpersonal and organizational skills to be a good team player. High sense of responsibility, dedication, and desire to work under pressure as required. Highly service oriented. Previous exposure to corporate environment, pharma and life sciences industry is an advantage. Good communication skills. Fluent in English- spoken and written. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity

Conduct Medical Review and assessment of ICSR s into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment. Review and respond to any queries/comments from the case owner in the patient safety database. Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers. Maintain strong GPVP and GCP knowledge. Following ICH and EMA guidelines strongly and implementing them appropriately. Train and mentor PV associates on event capturing and general PV conventions as required. Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas. Escalate complex case issues on client products to Team Lead/Line Manager. Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature. Provision of scientific input in the course of literature surveillance service. Maintain good knowledge of databases, regulations, guidelines and SOP s. To actively communicate and participate in internal project meetings. Participation in internal and external audits/inspections. Review and preparation of periodic safety reports (e.g., PSURs, PBRER) and RMPs. Collaborate with Global Pharmacovigilance team with respect to Signal Detection and its processes. Perform any other drug safety related activities as assigned. Qualification, experience & skills: Degree in Medicine. PG degree in any discipline is an advantage but not mandatory. Minimum 2 years of relevant experience in Pharmacovigilance & Drug Safety. Strong interpersonal and organizational skills to be a good team player. High sense of responsibility, dedication, and desire to work under pressure as required. Highly service oriented. Previous exposure to corporate environment, pharma and life sciences industry is an advantage. Good communication skills. Fluent in English- spoken and written.

Job Summary Join our dynamic team as a Pharmacovigilance Specialist where you will leverage Generative AI to enhance drug safety processes. This hybrid role offers the opportunity to work on cutting-edge projects in Research and Development and PV Case Processing ensuring the well-being of patients worldwide. With a focus on innovation you will contribute to the companys mission of improving healthcare outcomes. Responsibilities Utilize Generative AI tools to analyze and interpret pharmacovigilance data ensuring accurate and timely reporting. Collaborate with cross-functional teams to develop strategies for effective PV case processing and management. Conduct thorough research and development activities to improve drug safety protocols and procedures. Implement innovative solutions to streamline pharmacovigilance processes and enhance efficiency. Monitor and evaluate the impact of AI-driven methodologies on drug safety outcomes. Provide insights and recommendations based on data analysis to support decision-making in pharmacovigilance. Ensure compliance with regulatory requirements and industry standards in all pharmacovigilance activities. Participate in the development and maintenance of pharmacovigilance databases and systems. Support the preparation and submission of safety reports to regulatory authorities. Assist in the identification and assessment of potential safety signals and trends. Contribute to the continuous improvement of pharmacovigilance practices through research and innovation. Engage in knowledge sharing and training sessions to enhance team capabilities in AI and pharmacovigilance. Foster a collaborative environment that encourages creativity and problem-solving in drug safety initiatives. Qualifications Demonstrate proficiency in Generative AI and its application in pharmacovigilance processes. Possess a strong understanding of research and development methodologies in drug safety. Exhibit experience in PV case processing and management. Show familiarity with regulatory requirements and industry standards in pharmacovigilance. Display excellent analytical and problem-solving skills. Have the ability to work effectively in a hybrid work model. Demonstrate strong communication and collaboration skills. Certifications Required Certification in Generative AI applications in healthcare or pharmacovigilance.

Aster Medcity is looking for Registered Nurse to join our dynamic team and embark on a rewarding career journey. Supervise nursing staff in a hospital or clinical settings. Oversee patient care, make management and budgetary decisions, set work schedules, coordinate meetings, and make personnel decisions. Recruit and train nurses and other health care professionals and maintain a facilitys records. Work with staff to apply emerging nursing theories to care delivery. Also implement state and federal regulatory guidelines for patient safety and educate staff about any changes in the laws and how they impact care delivery.

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage Should have good communication Skills