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5.0 - 10.0 years

7 - 12 Lacs

Gurugram

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Employment Type: Contract Top 3 skills which is mandatory Aris, BPM, Functional and Technical Setup and ongoing maintenance and oversight of the ARIS architecture & libraries Design and develop the reporting capabilities on ARIS to meet the requirements of the Group Configuration of ARIS system for the Process Mapping team ensuring it remains fit for purpose for the Group`s requirements. Develop detailed understanding of ARIS standard setup and functionality Responsibility for the day-to-day administration of ARIS including user set up, licence allocation, recertification, etc. Ensure ARIS system procedures remain accurate and up-to-date with Group`s policies and standards. Repository Clean up Management of new library content scripts vs manual maintenance Integrations Vs schedule reports to ABACUS, Radar and HR Process Governance for change and release management ARIS reporting

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3.0 - 4.0 years

5 - 12 Lacs

Mumbai

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Job Summary The SME-Pharmacovigilance role is crucial for ensuring the safety and efficacy of pharmaceutical products. The candidate will leverage their expertise in PV Case Processing and customer service to enhance pharmacovigilance operations. This position requires a proactive approach to monitoring drug safety and contributing to research and development efforts. Responsibilities Triage & intake of ICSRs in ARGUS databases within agreed timelines Download and monitor valid ICSRs from Eudra Vigilance (EV)- or any other sources Process literature, spontaneous, clinical trial, and solicited cases Search for valid ICSRs in Literature search tools Generate reports and submit to health authorities and business partners Enter serious and non-serious ICSRs in ARGUS per client SOP and WI with high accuracy Code events, indications, patient history using MedDRA Code suspect products, amend narratives, and label events Obtain follow-up information for all cases per applicable guidelines Submit processed cases to regulatory authorities and distribute reports to Partners Communicate effectively with client stakeholders and internal teams Attend all internal and client trainings to ensure guideline compliance Ensure adherence to regulatory requirements and industry standards in all aspects of pharmacovigilance and safety operations. Assist in the development and maintenance of standard operating procedures to ensure consistency and quality in process execution. Support training and development initiatives to enhance team capabilities and knowledge in pharmacovigilance and safety operations. Utilize technical skills to troubleshoot and resolve process-related issues, minimizing disruptions and ensuring smooth operations. Engage in rotational shifts to provide consistent support and coverage across different time zones. Requirements Bachelor’s / Master’s degree in pharmacy. Minimum 3 years relevant work experience in case processing activities. Experience in Cardiovascular (CVS), Neuroscience (CNS), Oncology, Immunology therapeutic areas and Gene Therapy will be an added advantage. Experience with global pharma sponsor will be preferred. In-depth knowledge and understanding of applicable global, regional, and local regulatory requirements, including Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Conference of Harmonization (ICH) guidelines, SOPs. Excellent organizational and time management skills. Proficiency in Microsoft Office and web-based applications (e.g., Word, Excel, PowerPoint). Good knowledge of medical terminology.

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5.0 - 10.0 years

7 - 17 Lacs

Gurugram

Hybrid

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Employment Type: Contract Setup and ongoing maintenance and oversight of the ARIS architecture & libraries Design and develop the reporting capabilities on ARIS to meet the requirements of the Group Configuration of ARIS system for the Process Mapping team ensuring it remains fit for purpose for the Group`s requirements. Develop detailed understanding of ARIS standard setup and functionality Responsibility for the day-to-day administration of ARIS including user set up, licence allocation, recertification, etc. Ensure ARIS system procedures remain accurate and up-to-date with Group`s policies and standards. Repository Clean up Management of new library content scripts vs manual maintenance Integrations Vs schedule reports to ABACUS, Radar and HR Process Governance for change and release management ARIS reporting

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5.0 - 10.0 years

3 - 7 Lacs

Bengaluru

Hybrid

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Skills: Excellent writing and editing skills with the ability to create clear, concise, and engaging contentStrong knowledge of medical terminology, scientific concepts. #Exp5+ Years #LocationHydrabad (Hybrid) #clientNTTDATA. #Job description Good Experience in Medical Writer.

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1.0 - 3.0 years

4 - 7 Lacs

Pune

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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). Experience1-3 Years.

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4.0 - 8.0 years

5 - 8 Lacs

Hyderabad

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Role & responsibilities Responsible for daily case processing of adverse event cases (clinical trial and/or post marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level. Perform case follow up activities such as identification of information to be collected during follow-up. Creating and reviewing case narratives. Providing client notifications as required for case management. Case downloading from regulatory authority websites Submission to applicable regulatory authorities within stipulated timelines Supporting and contributing to the development of training materials and training delivery. Highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs. Acquire and maintain an up-to-date knowledge of global safety regulations for medicines. Peer reviews of cases for quality, consistency, and accuracy as needed. Other duties as assigned Preferred candidate profile Strong verbal, written and interpersonal communication skills. High level of accuracy and attention to detail. Excellent organization and prioritization skills; able to multitask. Basic knowledge of Pharmacovigilance. Interested applicants can also apply directly with updated CV to hr@qpsbioserve.com

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0.0 - 1.0 years

1 - 4 Lacs

Bengaluru

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Looking to onboard a highly motivated and detail-oriented individual with 0 to 1 years of experience to join our team as a Trainee Medical Reviewer in Pune. The ideal candidate will have excellent analytical skills, attention to detail, and the ability to work effectively in a fast-paced environment. Roles and Responsibility Conduct thorough medical reviews of patient records to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to identify and resolve issues related to medical review. Develop and maintain expertise in medical terminology, regulations, and guidelines. Analyze data to identify trends and areas for improvement in medical practice. Prepare reports and presentations to communicate findings and recommendations to stakeholders. Stay updated with changes in regulations and guidelines affecting medical practice. Job Strong understanding of medical terminology, regulations, and guidelines. Excellent analytical, communication, and problem-solving skills. Ability to work effectively in a team environment and prioritize tasks. Strong attention to detail and organizational skills. Familiarity with CRM/IT enabled services/BPO industry is an added advantage. Ability to learn quickly and adapt to new systems and processes. Educational qualificationAny Graduate or Postgraduate degree. About Company Omega Healthcare Management Services Pvt. Ltd. is a leading provider of healthcare management services, committed to delivering high-quality solutions to its clients. We are a dynamic and growing company, dedicated to innovation and excellence in all aspects of our operations.

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3.0 - 6.0 years

3 - 8 Lacs

Mumbai

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Business Unit PSL Product Team – Corporate, Institutional & Investment Banking PSL Product team takes care of entire priority sector lending portfolio for Corporate, Institutional & Investment Banking group. PSL product team is responsible for Identification, classification and reporting of Priority Sector book. The team is also responsible for working out structuring for various PSL deals in close co-ordination with Business units. Role PSL Product Manager Objective To drive Priority Sector Lending business, ensure accurate classification and reporting of PSL assets in Wholesale banking business Responsibilities PSL Reporting, PnL Management & Portfolio Management Ensure PSL reporting is completed timely and in adherence to extant regulatory guidelines and updation of Product notes or assigned products in line with change in regulations/RBI/SIDBI/Ministry of MSME etc. Managing the PSL portfolio of Wholesale banking and internal/external audits for this portfolio Drive projects for digitisation/ automation of PSL reporting Manage PnL for PSL portfolio of Wholesale banking Driving PSL Book Growth Drive PSL book growth for WBG organically & inorganically by way of Corporate linked PSL structure, securitization / on-lending etc. Generate vendor Financing and Agriculture PSL leads. Meet clients, structure PSL deal and conclude the same in close co-ordination with Relationship Team Prepare Program note incorporating PSL complaint structures and arrange approval from requisite sanctioning authority To execute client/ vendor (Farmer level) documentation in close co-ordination with on filed SeSo official and/or Business Correspondent Review PSL process note for process upgradation from time to time Due Diligence Conduct due diligence of PSL proposal post disbursement, by sample audits based on requirement. Drive PSL - to build mindshare towards PSL: Explore PSL opportunities in corporate banking Conduct trainings & reviews with Business team Experience CA/ MBA with 3-6 years of experience. Some experience in similar field is added advantage. Essential competencies - Flair to work in Priority Sector Lending Group - Good communication skills - Ownership, Result oriented , growth mind-set. Base Locations Kotak Mahindra Bank Mumbai

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5.0 - 10.0 years

2 - 3 Lacs

Mumbai

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Role – Team member – Compliance Experience – 5 years Grade – M5/M6 Qualification – CA/MBA Keeping track of updates in regulatory guidelines applicable to company, assess the impact on processes/policies and ensure implementation of changes. Driving compliance culture in organization and ensuring compliance with existing RBI guidelines Advising Business/credit on compliance related matters. Providing clarification to various stakeholders on compliance queries Maintaining policies of organization and ensuring periodic review of same as per regulatory/internal guidelines Submission of periodic RBI returns and responding to ad-hoc RBI data requirements Liaise with group company on compliance related matters and submission of periodic/ad-hoc data to group company Performing compliance reviews for different departments and periodical test checking of Internal Controls of the company Monitoring the compliance system of company and ensuring compliance of respective stakeholders on timely basis in system One point of contact of RBI and managing Internal/Statutory audits and RBI Inspections.

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15.0 - 20.0 years

11 - 15 Lacs

Chennai

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Project Role : Business Process Architect Project Role Description : Analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. Must have skills : SAP PP Production Planning & Control Discrete Industries Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Process Architect, you will analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. Roles & Responsibilities:- Expected to be an SME, collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Expected to provide solutions to problems that apply across multiple teams.- Collaborate with stakeholders to identify and document business requirements.- Design and implement business processes and workflows.- Analyze existing processes and identify areas for improvement.- Develop and maintain process documentation and standard operating procedures. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP PP Production Planning & Control Discrete Industries.- Strong understanding of business process analysis and design.- Experience in defining product requirements and use cases.- Knowledge of process improvement methodologies such as Lean or Six Sigma.- Experience with process modeling tools such as ARIS or Visio. Additional Information:- The candidate should have a minimum of 12 years of experience in SAP PP Production Planning & Control Discrete Industries.- This position is based at our Chennai office.- A 15 years full time education is required. Qualification 15 years full time education

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0.0 - 1.0 years

2 - 5 Lacs

Bengaluru

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Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English - Advanced 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.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 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 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 Pharmacy

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0.0 years

0 - 0 Lacs

Hyderabad, Bengaluru, Mumbai (All Areas)

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We are seeking a highly motivated and detail-oriented recent graduate to join our Drug Safety team as an Entry-Level Drug Safety Associate. This is an excellent opportunity to launch your career in the pharmaceutical industry and contribute to the safety surveillance of our products. You will gain practical experience in various aspects of drug safety, including adverse event processing, data entry, and safety reporting. This role is perfect for individuals with a strong interest in drug safety and a desire to learn and grow in a fast-paced environment. Responsibilities: Adverse Event Case Processing: Receive, triage, and accurately enter adverse event reports into the drug safety database. Ensure timely and accurate data entry in compliance with company Standard Operating Procedures (SOPs) and regulatory guidelines. Assist in the follow-up of adverse event reports to obtain complete and accurate information. Perform quality control checks on case data to ensure accuracy and consistency. Data Management and Safety Reporting: Assist in the preparation of safety reports and data summaries. Maintain accurate and organized drug safety records. Assist in the tracking and monitoring of adverse event trends. Learn to identify and escalate potential safety signals. Regulatory Compliance: Develop a basic understanding of global drug safety regulations and guidelines (e.g., ICH guidelines). Adhere to company SOPs and regulatory requirements. Assist in the preparation of regulatory submissions. General Support: Assist in the maintenance of drug safety databases and systems. Participate in team meetings and training sessions. Support senior drug safety staff as needed. Perform other duties as assigned. Qualifications: Bachelor's degree in Pharmacy, Pharmacology, Life Sciences, Nursing, or a related healthcare field. Strong interest in drug safety and pharmacovigilance. Excellent attention to detail and accuracy. Strong organizational and time-management skills. Ability to work independently and collaboratively within a team. Good communication and interpersonal skills. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Must be a recent graduate. Preferred Qualifications (but not required): Basic understanding of medical terminology. Familiarity with drug safety databases or systems. Coursework related to pharmacology or drug safety.

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5.0 - 10.0 years

7 - 12 Lacs

Hyderabad, Pune, Salem

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Safety Physician - ICSR Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job Responsibilities Performs medical review of adverse events reported for investigational and marketed products Maintains familiarity with MedDRA, WHO-DRL, and safety databases such as ARGUS. Works closely with Safety and Pharmacovigilance (SPVG) colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical and post-marketing safety information Identifies, communicates and effectively manages potential safety issues Interacts with client s safety/medical personnel as appropriate Stays abreast of clinical and drug development information relevant to contracted programs Provides medical review and interpretation for aggregate safety reports (e.g. annual safety reports, PSURs, PADERs) Maintains medical and pharmacovigilance expertise through appropriate internal or external continued medical education Assists as a mentor and trainer for other internal safety staff including case processing staff Responsible for performing activities that are in compliance with applicable Corporate and D Departmental Policies, Standard Operating Procedures, Work Instructions and any project specific Operating Guidelines Performing other duties as assigned by management. Qualifications The incumbent should possess M.D., MBBS, D.O. Completed an accredited residency; Minimum of one to two (1 to 2) years of experience in clinical practice Minimum of one year of experience in the pharmaceutical, biotechnology, or device industry working in pharmacovigilance/epidemiology preferred Knowledge of global pharmacovigilance regulations and processes Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), safety databases, and internet. Excellent verbal and written communication skills (proficient in English) as well as in the language required for case processing Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform and influence Ability to travel as necessary (up to 10%) Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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0.0 years

0 - 0 Lacs

Kolkata, New Delhi, Bengaluru

Hybrid

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We are seeking life science graduates interested in building a long-term career in the Clinical Research domain. This opportunity is part of our industry-integrated Clinical Research Training Program designed to prepare candidates for roles such as CRA, CRC, and Drug Safety Associate . Role Responsibilities (Post-Training Readiness) Understand and support clinical trial processes, site coordination, and documentation Learn Good Clinical Practices (GCP), ICH guidelines, and regulatory frameworks Monitor data collection and compliance Collaborate with CROs, hospitals, and research organizations (Post-placement) Eligibility Criteria Education: B.Sc, B.Pharm, M.Sc, BDS, BPT, BHMS, BAMS, Nursing, MBBS Background: Life Sciences or Healthcare domain Experience: 02 years Location: Open to all Indian cities (program delivered online & offline) Must have interest in Clinical Trials, Research, Pharmacovigilance, or Regulatory Affairs

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3.0 - 6.0 years

8 - 11 Lacs

Bengaluru

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Job Description:. Weekly Hours:. 40. Time Type:. Regular. Location:. IND:AP:Hyderabad / Argus Bldg 4f & 5f, Sattva, Knowledge CityAdm: Argus Building, Sattva, Knowledge City. It is the policy of AT&T to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, AT&T will provide reasonable accommodations for qualified individuals with disabilities. AT&T is a fair chance employer and does not initiate a background check until an offer is made.. Show more Show less

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3.0 - 6.0 years

5 - 9 Lacs

Mumbai, Nagpur, Thane

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Description Safety & PV Specialist I-Japanese -Pune Office Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required, Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required, Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability, Enters data into safety database, Codes events, medical history, concomitant medications, and tests, Compiles complete narrative summaries, Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved, Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements, Maintains safety tracking for assigned activities, Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required, Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA, Manual recoding of un-recoded product and substance terms arises from ICSRs, Identification and management of duplicate ICSRs, Activities related to SPOR / IDMP, Quality review of ICSRs, Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate, Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process, Fosters constructive and professional working relationships with all project team members, internal and external, Participates in audits as required/appropriate, Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities, Qualifications Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job,

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5.0 - 10.0 years

3 - 6 Lacs

Bengaluru

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Job Title: Radiotherapy Technologist Company: Manipal Hospitals Location: Yelahanka Job Description: We are seeking a skilled Radiotherapy Technologist to join our team at Manipal Hospitals in Yelahanka. The successful candidate will be responsible for delivering high-quality radiation therapy to patients undergoing treatment for cancer and other medical conditions. You will work closely with radiation oncologists and other healthcare professionals to ensure effective treatment plans and patient safety. Key Responsibilities: - Operate and maintain radiotherapy equipment, including linear accelerators and other related devices. - Prepare patients for radiation treatment and explain procedures to ensure their comfort and understanding. - Position patients accurately and ensure correct radiation dosage is administered according to physician instructions. - Conduct quality assurance checks on equipment to ensure optimal functioning and compliance with safety standards. - Monitor and document patient's progress throughout the treatment process and report any changes to the healthcare team. - Maintain accurate and up-to-date patient records in compliance with hospital policies. - Adhere to infection control protocols and safety guidelines to ensure a sterile working environment. - Participate in continuing education and professional development to enhance skills and knowledge in the field. Skills and Qualifications: - Bachelor’s degree in Radiation Therapy or a related field. - Certification from a recognized professional body in Radiation Therapy. - Proven experience working as a Radiotherapy Technologist, preferably in a clinical or hospital setting. - Strong understanding of radiotherapy techniques and patient care protocols. - Excellent communication skills, with the ability to interact with patients and their families empathetically. - Attention to detail and strong organizational skills. - Ability to work effectively in a team and collaborate with healthcare professionals. - Proficient in using radiotherapy technology and computer software related to patient management. Tools and Equipment: - Linear accelerators - Radiation treatment planning systems - Imaging equipment (CT, MRI, etc.) - Patient monitoring systems - Electronic health record (EHR) systems - Quality assurance tools and testing devices We invite qualified candidates to apply and join our dedicated team at Manipal Hospitals, where you can make a difference in the lives of patients through effective radiotherapy treatment. Roles and Responsibilities About the Role: As a Radiotherapy Technologist at Manipal Hospitals, you will play a crucial role in the delivery of radiation therapy to cancer patients. You will operate advanced radiotherapy equipment, ensuring accurate treatment delivery and patient safety. Your responsibilities will include collaborating with oncologists and other healthcare professionals to develop and implement treatment plans. About the Team: You will join a dedicated team of healthcare professionals committed to providing high-quality cancer care. The team is composed of radiation oncologists, medical physicists, nurses, and other allied health staff who work collaboratively. This supportive environment fosters continuous learning and professional development. You are Responsible for: - Preparing and positioning patients for radiotherapy treatments to ensure accurate delivery. - Operating and maintaining radiotherapy equipment while adhering to safety protocols. - Conducting quality assurance checks to verify the accuracy and efficacy of treatment plans. - Maintaining detailed records of patient treatments and equipment performance. To succeed in this role – you should have the following: - A degree or diploma in Radiotherapy Technology from a recognized institution. - Proficiency in operating radiotherapy equipment and understanding treatment planning systems. - Excellent communication and interpersonal skills to effectively interact with patients and team members. - Strong attention to detail and a commitment to patient safety and care standards.

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5.0 - 6.0 years

6 - 10 Lacs

Mumbai

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About The Role Credit Card Process Manager Marketing HO Department Credit Card Products Location Infiniti IT park Reporting Relationship Position Grade Senior Manager Job Role Process designing for Credit Cards covering key aspects of Process Workflows (Digital / Physical), Compliance, Risk, Legal, Ops, Customer Experience, etc. Creating and documenting SOPs/Process notes of various Credit Card processes with clear defined roles and responsibilities to promote efficient implementation. Ability to think through end to end process at various touchpoints such as online channels, partners, Branches, Call center etc. Review processes in light of Fraud and Risk raised by RCU and ORM. Identification of Risks and Regulatory breach on cards processes and provide solution to mitigate risks and control reports to minimize process lapses. Monitor and govern if the defined processes are being executed from time to time, including regulatory changes In-depth understanding of KYC and Other Regulatory Guidelines. Providing tailor made solution to Product / Operations for specific business requirement. Ideate & suggest Product and Operations with end to end execution of a Process / Digital Journey"™s / new initiatives / features etc. Ensuring the Digital Journey controls and logics is in line with defined Process, Regulation and Risk perspective Responsible for the documentation of Business Processes, workflows. Publish MIS and Reports Job Requirement Graduate/Post-Graduate with at least 5 to 6 years of experience in Business Processes In-depth knowledge of Credit Cards business Knowledge of Regulatory requirements and market competition/intelligence will be an added advantage. Excellent communication skills Verbal & Written Good Logical reasoning and data analysis skill Should be able to think proactively for process changes from Business Process Re-engineering perspective Assertive attitude Self-Driven and ability to follow-up promptly Good analytical skills & eye for details

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6.0 - 11.0 years

10 - 14 Lacs

Lucknow

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Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations Internal Relations Educational qualifications preferred Category Bachelor's Degree

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1.0 - 6.0 years

15 - 27 Lacs

Mumbai

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SUMMARY Job Title: SAR & SAR-like Patient Safety Physician Reporting To: Patient Safety Physician SAR & SAR-like Coordinator Minimum Educational Qualifications and Experience Required Skills Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Operational Responsibilities Compile PBRERs with a focus on medical aspects and safety sections of products, and analyze safety trends, including source data analysis based on queries Assist in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborate with Therapeutic Head to identify signals and address product safety concerns Engage with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensure 100% compliance with timely completion of all client and Cognizant required trainings Achieve 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities

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1.0 - 3.0 years

15 - 20 Lacs

Chennai

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Position Purpose: Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer s products and to meet regulatory requirements. Primary Responsibilities: Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays. Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately. Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness / listedness / labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly. Review case criteria to determine the appropriate workflow for case processing. Write and edit the case narrative. Generate reports, ensuring adherence to regulatory compliance timelines. Determine appropriate case follow-up, requesting follow-up letters when appropriate. Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation. Develop and maintain expertise and knowledge of all products within the Pfizer portfolio; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database. Consistently apply regulatory requirements and Pfizer policies. Qualifications (i. e. , preferred education, experience, attributes): Masters degree in healthcare profession (ie, Pharmacy, Dentistry, Nursing etc). 1-3-years experience in pharmacovigilance/ related domains. Work Location Assignment: Hybrid Medical #LI-PFE

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3.0 - 5.0 years

5 Lacs

Chennai

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Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS/MD Years of Experience: 3 to 5 years Language - Ability: English(International) - Proficient 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 Performs Medical Assessment activities related to drug safety Pharmacovigilance for the Individual Case Safety Reports- Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals- Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP- Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables- Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable- Performs labelling of events of applicable cases- Provides Medical Expertise to case processing team whenever required- Provides training/mentoring to the team members wherever applicableCreate 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 Understanding of PharmacovigialnceExperience in Medical Review of ICSRsMedical Review Roles and Responsibilities: - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals- Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP- Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables- Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable- Performs labelling of events of applicable cases- Provides Medical Expertise to case processing team whenever required- Provides training/mentoring to the team members wherever applicable Qualification MBBS,MD

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10.0 years

11 - 16 Lacs

Sahibzada Ajit Singh Nagar

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When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Purpose: Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products Provide medical guidance and input to Drug Safety Associates (DSAs) and specialists in medical aspects of drug safety Function as pharmacovigilance representative/safety scientist General Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and international drug safety regulations Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Maintaining excellent knowledge of the safety profile of assigned products Communicating and discussing issues related to review process with Project Manager Interacting with internal and external contacts for resolving issues Maintaining a good working knowledge of relevant regulatory guidelines Attend and present client/cross functional meetings along with other stakeholders Training and mentoring new team member, as required Working as Subject Matter Experts (SMEs) Assisting the Manager for inspection readiness activities and audits Provides inputs for process improvisations Works closely with Manger for process co-ordination and to ensure meeting all KPIs for the process. Case report Medical review (as applicable) Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality Assessing seriousness and expectedness of reported events Providing medical advice to DSPs and case processing team Skills: Excellent interpersonal, verbal and written communication skills Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system Client focused approach to work A flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential Willingness to work in a matrix environment and to value the importance of teamwork Strong knowledge of international drug regulation including GCP, GVP Knowledge and Experience: Relevant experience of minimum 2 Years in Pharmacovigilance/ drug safety is desirable. Education: MBBS/Post Graduation in Medicine.

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4.0 - 5.0 years

13 - 15 Lacs

Pune

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Position Summary This role requires working as part of the Safety System Administrator Team performing database administration activities; supporting creation and upgrade of database instances; change control and data migration activities; first line user support and troubleshooting; and training users on databases. Principal Responsibilities The Safety System Administrator is primarily responsible for: Maintenance of database libraries Involvement in system validation activities Interrogating the database and generating outputs for internal and client use Training and providing database access to internal and client users Principle Functions For the Client (may include but is not limited to the following) Set up and maintenance of project specific database libraries including: o Products o Licenses o Studies o Reporting destinations Documenting and validating any change to the project specific database Support during legacy data transfer e.g., validation Supporting/providing guidance to the Project Manager / Client / Project Start Up Team during the development of project specific data handling guidelines (to ensure project specific guidelines are necessary and will not impact line listings and report generation) Prepare line listings and tabulations and other database outputs for use in aggregate reports, signal detection, reconciliation and other activities as required Provide case processing metrics required for invoicing (e.g., number of submissions, number of spontaneous vs initial cases processed) Provide database training to clients Providing and documenting client / internal team access upon receipt of an approved access request. For the Company (may include but is not limited to the following) Coordinate user access (including maintenance and revoking access) Maintain database procedures including core data handling conventions Provide database training and certification to PrimeVigilance users Provide user support Involvement in root cause investigation of database related deviations and ensure timely and complete documentation of resulting actions in line with Quality procedures Provide case processing quality and compliance metrics to the Quality Team Identify areas for improvement and address via training, clarifying changes to data handling guidelines, user guides etc. Execute business continuity periodic testing for database failure Ensure that existing software bugs, user requests, changes to regulatory requirements etc., are considered and appropriate changes are made and validated as required Support IT, database vendor and technical colleagues in troubleshooting and implementing software fixes and enhancements as required Other Supportive Responsibilities Assist PrimeVigilance senior management on an as needed basis. Potentially provide chargeable consulting / training activities to clients regarding Argus, and if required LSSMV. Educated to degree standard Demonstrated work experience within Argus Safety Systems.

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4.0 - 5.0 years

13 - 15 Lacs

Pune

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Position Summary This role requires working as part of the Safety System Administrator Team performing database administration activities; supporting creation and upgrade of database instances; change control and data migration activities; first line user support and troubleshooting; and training users on databases. Principal Responsibilities The Safety System Administrator is primarily responsible for: Maintenance of database libraries Involvement in system validation activities Interrogating the database and generating outputs for internal and client use Training and providing database access to internal and client users Principle Functions For the Client (may include but is not limited to the following) Set up and maintenance of project specific database libraries including: o Products o Licenses o Studies o Reporting destinations Documenting and validating any change to the project specific database Support during legacy data transfer e.g., validation Supporting/providing guidance to the Project Manager / Client / Project Start Up Team during the development of project specific data handling guidelines (to ensure project specific guidelines are necessary and will not impact line listings and report generation) Prepare line listings and tabulations and other database outputs for use in aggregate reports, signal detection, reconciliation and other activities as required Provide case processing metrics required for invoicing (e.g., number of submissions, number of spontaneous vs initial cases processed) Provide database training to clients Providing and documenting client / internal team access upon receipt of an approved access request. For the Company (may include but is not limited to the following) Coordinate user access (including maintenance and revoking access) Maintain database procedures including core data handling conventions Provide database training and certification to PrimeVigilance users Provide user support Involvement in root cause investigation of database related deviations and ensure timely and complete documentation of resulting actions in line with Quality procedures Provide case processing quality and compliance metrics to the Quality Team Identify areas for improvement and address via training, clarifying changes to data handling guidelines, user guides etc. Execute business continuity periodic testing for database failure Ensure that existing software bugs, user requests, changes to regulatory requirements etc., are considered and appropriate changes are made and validated as required Support IT, database vendor and technical colleagues in troubleshooting and implementing software fixes and enhancements as required Other Supportive Responsibilities Assist PrimeVigilance senior management on an as needed basis. Potentially provide chargeable consulting / training activities to clients regarding Argus, and if required LSSMV. Qualifications Educated to degree standard Demonstrated work experience within Argus Safety Systems.

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