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0.0 - 4.0 years

0 Lacs

haryana

On-site

Represent our clients on various projects by performing data entry and case processing of forms. Manage daily activities related to patient and healthcare provider support requests through different communication channels such as Fax, Chat, and Email. Conduct intake of cases and accurately capture all relevant information in the Case Management system. Ensure that all support requests are properly logged in the system and directed to the appropriate next step using decision tools and reference guides. Guarantee timely and precise processing of requests by reviewing source documentation. Escalate complex cases when necessary. Uphold high-quality standards for all client programs, complying with program requirements and guidelines. Precisely transcribe and document information from forms into client databases. Reporting to the Call Center Supervisor and Operations Manager. Key Objectives: - Maintain exceptional quality standards for all client programs and adhere to program guidelines. - Accurately transcribe and enter data required by individual programs into specific databases. - Adhere to company policies and Standard Operating Procedures. - Demonstrate flexibility within the department to optimize utilization. - Showcase highly effective transcription and data entry skills meeting or exceeding productivity expectations. - Ensure patient privacy and confidentiality according to the guidelines of the Health Insurance Portability and Accountability Act (HIPAA). Job Holder Specification: - Excellent English verbal, written, and listening communication skills are essential. - Bachelor's degree (Preferred final year pharmacy/biotech/physiotherapy graduates) or equivalent work experience. - Knowledge of reimbursement mechanisms for medical and pharmacy benefits, patient access processes, and patient assistance programs is preferred. - Proficient in reviewing intake documents thoroughly and entering information in databases with minimal errors. - Proficiency in Word and Excel. - Strong analytical thinking, problem-solving, and decision-making abilities. - Ability to multitask and manage multiple projects simultaneously with excellent time management skills. Location: The job holder must be based in Gurgaon. Values: Partnership: Building trust through delivering promises and working in partnership with clients and colleagues. Customer Focus: Upholding responsibilities for internal and external customers, demonstrating high ethical standards and honesty in dealings. Teamwork: Working effectively in diverse teams, valuing different perspectives and experiences. Ingenuity: Committed to solving problems and innovative thinking. Quality: Setting high standards, developing capabilities, and delivering quality services. Energy: Achieving goals with passion, engaging, listening, and working together. Expertise: Leveraging knowledge and skills to deliver excellence and enhance client experience. Our company is committed to creating a diverse, inclusive, and authentic workplace. If you are enthusiastic about the role but do not meet every qualification, we encourage you to apply as you may be the right fit.,

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2.0 - 5.0 years

6 - 10 Lacs

Thane

Work from Office

The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products. Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product s safety profile (e. g: DSUR, RMP, PBRER, ad hoc regulatory reports etc) Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment. Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable 24 hour medical support as required on assigned projects Maintain awareness of medical safety-regulatory industry developments Provide support and participate in signal detection efforts, e. g. strategy meetings etc. as applicable Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. Req Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req Two (2) years of pharma experience Pref Sound knowledge of Medicine In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i. e. , Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Knowledge of Pharmacovigilance- ICSR and Aggregate reports In-depth knowledge of departmental standard operating procedures (SOPs) Skill in use of multiple safety databases Adequate Computer skills, especially Microsoft word, excel & PowerPoint Good communication skills- verbal and written Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs. iqvia. com

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0.0 - 1.0 years

1 - 4 Lacs

Bengaluru

Work from Office

Looking for a motivated individual to join our team as a Trainee Medical Reviewer in Bengaluru. The ideal candidate should have 0-1 years of experience. Roles and Responsibility Conduct thorough medical reviews of patient records and reports to ensure accuracy and 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. Provide high-quality support to internal stakeholders through effective communication and documentation. Stay updated with changes in regulations and guidelines affecting medical review processes. Participate in quality improvement initiatives to enhance the efficiency and effectiveness of medical review activities. Job Requirements Strong understanding of medical terminology, regulations, and guidelines. Excellent analytical and problem-solving skills with attention to detail. Ability to work effectively in a team environment and communicate complex information clearly. Proficiency in using electronic health records systems and other healthcare software applications. Strong organizational and time management skills with the ability to prioritize tasks and meet deadlines. Commitment to delivering high-quality results and maintaining confidentiality and professionalism. Omega Healthcare Management Services Private Limited is a leading provider of healthcare management services, committed to delivering exceptional care and customer satisfaction. We are an IT-enabled services company that uses technology to improve healthcare operations and outcomes.

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0.0 - 4.0 years

0 Lacs

haryana

On-site

Represent our clients on various projects by performing data entry and case processing of forms. Manage day-to-day activities related to patient and healthcare provider support requests and deliverables through multiple communication channels such as fax, chat, and email. Conduct intake of cases and accurately capture all relevant information in the Case Management system. Ensure all support requests are documented within the Case Management system and directed to the appropriate next step using decision tools and reference guides. Guarantee timely and precise processing of requests by reviewing source documentation. Escalate complex cases when necessary. Maintain high-quality standards for all client programs and comply with program requirements and guidelines. Accurately transcribe and document information received via forms into client databases. Reporting to the Call Center Supervisor and Operations Manager, you will be responsible for maintaining excellent quality standards for all client programs and accurately transcribing and entering data required by individual programs into specific databases. Adhere to all company policies and Standard Operating Procedures. Exhibit flexibility within the department to maximize efficiency. Demonstrate proficient transcription and data entry skills, meeting or exceeding productivity expectations. Ensure patient privacy and confidentiality by following the guidelines set forth in the Privacy and Security Rules of the Health Insurance Portability and Accountability Act (HIPAA). The ideal candidate should possess excellent English verbal, written, and listening communication skills. A Bachelor's degree is preferred, or equivalent work-related experience, especially for final year pharmacy, biotech, or physiotherapy graduates. Knowledge of reimbursement mechanisms for medical and pharmacy benefits, patient access processes, and patient assistance programs is advantageous. Proficiency in reviewing intake documents thoroughly and entering information in databases with minimal errors is required. Proficiency with Word and Excel is essential. Strong analytical thinking, problem-solving, and decision-making skills are necessary. Ability to multitask and manage multiple projects simultaneously with excellent time management skills is a must. Location: The job requires the candidate to be based in Gurgaon. Our values at Ashfield highlight the importance of Partnership, Customer Focus, Teamwork, Ingenuity, Quality, Energy, Expertise, and Accountability. We believe in building relationships based on trust, integrity, and transparency. Upholding responsibilities and obligations for internal and external customers, maintaining high ethical standards, and putting the customer first are key aspects of our values. We encourage teamwork, valuing diverse perspectives and experiences, and fostering excellent interpersonal and communication skills. We are committed to problem-solving through resourceful thinking, innovation, and creativity. Quality is at the core of everything we do, striving for excellence and continuous improvement in all aspects of work. At Ashfield, we are dedicated to building a diverse, inclusive, and authentic workplace. If you are excited about this role but do not meet every job requirement, we encourage you to apply anyway. We believe that you may be the right fit for this role or others within our organization.,

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5.0 - 9.0 years

0 Lacs

maharashtra

On-site

The Manager, Global PV System Operations at Kenvue is a key role reporting to the Associate Director, Global PV System Operations (GPSO) and is based in India. As a Kenvue employee, you will be part of a global team dedicated to delivering the best products to customers and impacting the lives of millions of people every day. With a focus on science, care, empathy, and trust, Kenvue offers brilliant opportunities for individuals passionate about insights and innovation. In this role, you will be responsible for supporting the Director, GPSO in maintaining Pharmacovigilance (PV) System Operations. This includes partnering with internal and vendor Information Technology teams, as well as Safety Science and Analytics (SSA) on implementing new systems, maintaining existing systems, and providing user support for vendor-supported systems. Your key responsibilities will involve overseeing vendor staff, managing system activities, assisting in the implementation of new PV systems and upgrades, and ensuring compliance with regulatory requirements. You will also play a crucial role in liaising with various functions to facilitate timely case processing and reporting activities, managing staff aligned with strategic goals, leading CAPA management, participating in audits and inspections, and developing Standard Operating Procedures (SOPs)/Work Instructions (WIs) related to safety information reporting. The ideal candidate will have a BA or BSc degree in a health-related field, broad knowledge of pharmacovigilance, industry experience in consumer safety, and project management skills. Desired qualifications include experience in leading global projects and thriving in a matrix environment. Kenvue offers a competitive Total Rewards Package, learning and development opportunities, and a supportive work environment. Join us at Kenvue and be part of shaping the future while advancing your career in Drug & Product Safety Science.,

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1.0 - 3.0 years

2 - 6 Lacs

Mumbai

Work from Office

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 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 Drug saftey associate 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 Qualification Bachelor of Pharmacy,Master of Pharmacy

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5.0 - 8.0 years

7 - 11 Lacs

Chennai

Work from Office

About The Role Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Senior Analyst Qualifications: BCom Years of Experience: 5 to 8 years Language - Ability: English(Domestic) - Intermediate 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 We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for Ability to handle disputesAbility to meet deadlinesAbility to perform under pressureAbility to work well in a teamAdaptable and flexible Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification BCom

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1.0 - 3.0 years

2 - 6 Lacs

Bengaluru

Work from Office

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 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 Drug Safety AssociateDrug Safety Associate 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 Qualification Bachelor of Pharmacy,Master of Pharmacy

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1.0 - 3.0 years

5 - 9 Lacs

Mumbai

Work from Office

About The Role Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: Any Graduation Years of Experience: 1 to 3 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 We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for Ability to establish strong client relationshipAbility to handle disputes 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 Qualification Any Graduation

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10.0 - 20.0 years

7 - 11 Lacs

Bengaluru

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The Infection Control Nurse at Manipal Hospitals will be responsible for monitoring and preventing infections within the healthcare facility. This role involves developing and implementing infection control policies, protocols, and practices to ensure the safety of patients, staff, and visitors. The nurse will conduct regular training sessions for healthcare personnel to promote awareness of infection control measures. Additionally, the Infection Control Nurse will collect and analyze data related to infection rates, investigate outbreaks, and report findings to the healthcare team and relevant authorities. Collaborating with multidisciplinary teams will be crucial for achieving the organization's infection control goals. Key Responsibilities: - Monitor and track infection rates and trends within the hospital. - Develop and implement evidence-based infection prevention and control policies. - Conduct regular audits and inspections to ensure compliance with infection control standards. - Provide education and training to healthcare staff on infection prevention practices. - Investigate infection outbreaks and implement appropriate control measures. - Maintain accurate records and documentation related to infection control activities. - Educate patients and their families on infection prevention strategies. - Collaborate with healthcare professionals to improve patient outcomes related to infections. Skills and Tools Required: - Registered Nurse (RN) license and a valid nursing practice certificate. - Certification in Infection Control (CIC) is preferred. - Strong knowledge of infection control practices and healthcare regulations. - Excellent analytical and problem-solving skills. - Strong communication and interpersonal skills for effective staff education and patient interaction. - Proficiency in data collection and analysis related to infections. - Familiarity with infection control software and electronic health records systems. - Ability to work in a fast-paced environment and manage multiple priorities. - Attention to detail and commitment to maintaining high standards of patient care. This position offers an opportunity to make a significant impact on patient safety and quality of care within a prestigious healthcare organization. Roles and Responsibilities About the Role: The Infection Control Nurse at Manipal Hospital, Yelahanka, plays a crucial role in preventing and controlling the spread of infections within the healthcare facility. This position involves implementing infection control policies, conducting training programs, and monitoring compliance with established protocols. You will work closely with various departments to ensure patient and staff safety while maintaining high standards of care. About the Team: You will be part of a dedicated and multidisciplinary team focused on enhancing patient safety and quality of care. The team consists of healthcare professionals who continuously collaborate to address infection prevention challenges. This supportive environment encourages knowledge sharing and professional growth while prioritizing the health and well-being of patients and staff alike. You are Responsible for: Conducting regular surveillance of infection rates and identifying areas for improvement. Developing and implementing infection prevention protocols and training programs for staff. Conducting audits and assessments to ensure adherence to infection control practices. Collaborating with healthcare providers to manage outbreaks and implement control measures. Providing education and resources to patients and families regarding infection prevention. To succeed in this role – you should have the following: A relevant nursing degree and certification in infection control or epidemiology. Strong knowledge of infection control practices, standards, and regulations. Excellent communication and interpersonal skills for effective collaboration. Analytical skills for data collection and interpretation. A proactive approach to problem-solving and the ability to work in a fast-paced environment.

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4.0 - 5.0 years

4 - 8 Lacs

Kolkata, Mumbai, New Delhi

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MISSION: The Case Specialist s job is to guarantee the optimised management of vigilance cases, using their scientific knowledge to enable a detailed analysis of the various files. He/she is the guarantor of the proper handling of a case, both from a regulatory and medical point of view, and in this respect masters the regulations in force. He/she must be able to validate all tasks related to the exploitation of cases, from their collection to their submission. In addition, he/she contributes to the smooth running of his/her Line Of Business. Main activities and technical skills: VIGILANCE CASES: Responsible for the Quality Control (QC) of vigilance cases. The QC includes fields: Coding according to applicable dictionary (MedDRA/IMDRF/Product/WHO or other). Seriousness of the events/effects/incidents . Expectedness/listedness. Data entry of vigilance cases in ad hoc databases or in formats defined with the client. Follow-up request of vigilance cases by phone/mail Suggesting queries to complete the case. Confirm or support Data Officers submission requirements. Validation of documents within the Safety and Vigilance platform. Analysis of inclusion/exclusion for cases received from EV or MHRA ICSR download. Reconciliation activities. MEDICAL INFORMATION: In support of the medical information line of Business Taking phone calls reporting vigilance notifications. CUSTOMER/PROCESS MONITORING: Participation in the operational implementation of new clients. Key contact with clients (with the support of a senior member of staff or the division manager). Drafting/updating of technical agreements /safety management plan / client template (for a trial for example) Drafting/updating of procedures/ operating methods or others directly related to its activity Participation in the implementation/ maintenance/ improvement of processes Additional Activities: Participation in the coordination of Case Management by relaying to the coordinator if necessary. Support for the coordination of activities (including planning and monitoring) ensuring effective communication to the coordination team regarding cases received with short timelines to meet regulatory deadlines. Required Education: BPharm / MPharm Required Experience: 4-5 years Required Technical Skills: Well versed with MS Office, Safety Databasea Additional Skills & Experience: Presentation skills, Communication Skills, Should be well versed with pharmacovigilance basics, case processing and associated conventions, thorough knowledge of GVP modules, ICH guidelines, regulatory requirements, MedDRA coding, well versed with safety databases, solution oriented.

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3.0 - 7.0 years

0 Lacs

maharashtra

On-site

The ideal candidate for this position should have a qualification of B. Pharm / M. Pharm/ BAMS/ BHMS. The job is located in Mumbai and Pune, India. You should have a minimum of 3-4 years of experience in case processing/ safety writing and knowledge of SDEA management. It is essential to have experience in exchanging safety data / conducting reconciliations with business partners. Strong written and verbal communication / presentation skills are also required. Keeping updated with the latest technical / scientific developments related to PV is crucial for this role. As part of your responsibilities, you will need to initiate communications with internal stakeholders such as business teams and subsidiaries to understand the requirements of SDEAs. Following up with third parties/business partners to ensure SDEAs are in place is also a key responsibility. Timely exchange of safety data with partners and conducting adverse event reconciliation with partners are tasks that you will be expected to perform. If you meet the qualifications and are interested in this position, please share your CV on hr@fidelityhs.com.,

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2.0 - 5.0 years

1 - 5 Lacs

Chennai

Work from Office

About the job Use Your Power for Purpose At Pfizer, our Worldwide Medical and Safety colleagues are pivotal in bridging evidence-based medical decision support with stakeholders to enhance health and treatment outcomes. Whether you are developing frameworks to ensure our evidence is scientifically robust, offering unbiased and medically essential expertise, or exploring ways to address data gaps, our mission remains clear: to empower healthcare decisions regarding the safe and appropriate use of medicines for patients. Organizational Relationship(s) including to whom the position reports to: Case Processing Team Lead 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) Minimum a bachelor s degree in healthcare professional qualification (ie, Pharmacy, Dentistry, Nursing etc). 1 3-years experience in pharmacovigilance/ related domains. Work Location Assignment: Hybrid Medical #LI-PFE

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0.0 - 1.0 years

2 - 3 Lacs

Visakhapatnam, Guntur, Warangal

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Manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. Conducts research to ensure these products are safe. Ordering, tracking, and managing IP and trial materials. Required Candidate profile Knowledge of the pharmaceutical industry, terminology, and practices. - Knowledge of FDA regulations and their practical implementation. - Strong verbal and written communication skills.

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1.0 - 2.0 years

3 - 4 Lacs

Hyderabad, Pune, Bengaluru

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We are currently hiring for DSA I role with a minimum of 1 year experience in Pharmacovigilance Perform triage & intake of ICSR received daily in ARGUS databases. Ensure data entry of ICSR in ARGUS Required Candidate profile A minimum of 1 year pharmacovigilance case processing experience. Responsible for coding events using MEDDRA Any Life Sciences(B pharm/M Pharm/ Pharm D, Life Sciences, Nursing, BDS, BPT) are Eligible

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0.0 - 1.0 years

2 - 3 Lacs

Hyderabad, Pune, Chennai

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Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines Processing literature, spontaneous clinical trial and solicited cases Responsible for coding events, indications and patient history based on MEDDRA Required Candidate profile EDUCATION: M.Pharm/Pharm D/Life sciences / Microbiology / Biotech /Biochem /Nursing / BDS EXPERIENCE: Strong Knowledge in pharmacovigilance With Certification or its equivalent.

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3.0 - 5.0 years

18 - 20 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role you will join a collaborative team implementing and supporting the integrated case management systems on existing & future technologies. In this role, you will wear multiple hats including writing test scripts, implementing, analyze and resolve issues with case intake and data transfer across integrated systems. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient processing of data. Roles & Responsibilities: Monitor, test, and resolve issues related to case intake and case processing across multiple systems. Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues Ownership in the development of test plans, scenarios to ensure robust validation of system updates, patches and new features Create test scripts, perform regression & functional testing to verify the changes do not negatively impact existing system functionality What we expect of you We are all different, yet we all use our unique contributions to serve patients. Master s degree and 1 to 3 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree and 3 to 5 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma and 7 to 9 years of Life Science / Biotechnology / Pharmacology / Information Systems experience Preferred Qualifications: Functional Skills (Must Have) Experience in user requirements and acceptance criteria in agile project management systems such as JIRA and identification and execution of scripts. Experience in management of test plan, test protocols, defect management, and requirements traceability matrix Hands-on experience with the ITIL framework and methodologies like (Scrum). Hands on experience in HP ALM, JIRA, Visio, document management systems (e.g: Veeva) and Service Now. Good to Have Experience of DevOps, Continuous Integration, and Continuous Delivery methodology, and CRM systems Excellent communication skills and the ability to collaborate with Product Managers and business collaborators to define scope and value for new developments Soft Skills: Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Team-oriented, with a focus on achieving team goals Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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1.0 - 3.0 years

2 - 6 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role you will maximises domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with business collaborators, Data engineers, AI/ML engineers to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with the Product Owner and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. Roles & Responsibilities: Collaborate with System Architects and Product owners to manage business analysis activities, ensuring alignment with engineering and product goals. Monitor, solve, and resolve issues related to case intake and case processing across multiple systems. Work with Product Owners and customers to define scope and value for new developments. Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators. Design, implement, and maintain automated CI/CD pipelines for seamless software integration and deployment. Collaborate with developers to enhance application reliability and scalability. Troubleshoot deployment and infrastructure issues, ensuring high availability. Collaborate with business subject matter experts, testing teams and Product Management to prioritize release scopes and groom the Product backlog. Maintain and ensure the quality of documented user stories/requirements in tools like Jira. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree and 3 to 5 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma and 7 to 9 years of Life Science / Biotechnology / Pharmacology / Information Systems experience Preferred Qualifications: Functional Skills: Must-Have Experienced in MuleSoft, Java, J2ee & database programming. Demonstrated expertise in monitoring, troubleshooting, and resolving data and system issues. Proficiency in CI/CD tools (Jenkins, GitLab CI/CD, GitHub Actions, or Azure DevOps). Hands-on experience with the ITIL framework and methodologies like (Scrum). Knowledge of SDLC process, including requirements, design, testing, data analysis, change control Functional Skills: Good to Have Experience in managing GxP systems and implementing GxP projects. Knowledge of Artificial Intelligence (AI), Robotic Process Automation (RPA), Machine Learning (ML), Natural Language Processing (NLP) and Natural Language Generation (NLG) automation technologies with building business requirements. Knowledge of cloud technologies such as AWS. Excellent communication skills and the ability to communicate with Product Managers and business collaborators to define scope and value for new developments. Experience of DevOps, Continuous Integration, and Continuous Delivery methodology, and CRM systems Soft Skills: Excellent analytical and troubleshooting skills Able to work under minimal supervision Strong verbal and written communication skills High degree of initiative and self-motivation Team-oriented, with a focus on achieving team goals Ability to manage multiple priorities successfully Ability to deal with ambiguity and think on their feet Shift Information: This position may require you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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1.0 - 3.0 years

2 - 6 Lacs

Hyderabad

Work from Office

Let s do this. Let s change the world. In this vital role you will join a collaborative team implementing and supporting the Integrated Case Management Systems on existing & future technologies. In this role, you will wear several hats including requirement gathering, implementation and analyze and resolve issues with case intake and data transfer across integrated systems. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient processing of data. Roles & Responsibilities: Develop and implement business process improvements to enhance efficiency and effectiveness. Monitor, solve, and resolve issues related to case intake and case processing across multiple systems. Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues. Collaborate on the development of test plans and scenarios to ensure robust validation of system updates, patches and new features. Perform regression testing to verify the changes do not negatively impact existing system functionality. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree and 3 to 5 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma and 7 to 9 years of Life Science / Biotechnology / Pharmacology / Information Systems experience Preferred Qualifications: Functional Skills: Must-Haves Experience in writing user requirements and acceptance criteria in agile project management systems such as JIRA Good communication skills and the ability to communicate with Product Managers and business collaborators to define scope and value for new developments Hands-on experience with the ITIL framework and methodologies like (Scrum). Knowledge of SDLC process, including requirements, design, testing, data analysis, change control Functional Skills: Good to Have Hands on experience in HP ALM, JIRA, Visio, document management systems (e.g. Veeva) and Service Now Experience in management of requirements specifications document, requirements traceability matrix Experience of DevOps, Continuous Integration, and Continuous Delivery methodology, and CRM systems Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Team-oriented, with a focus on achieving team goals. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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3.0 - 8.0 years

3 - 6 Lacs

Hyderabad

Work from Office

Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support. Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases processed by vendors Ensure Vendors deliver high quality cases through metric management meet all worldwide regulatory authority requirements Provide vendors with resources and training to perform their role Analysis and communication of case Quality Control results Responsible for escalation of case related issues from vendor(s) Providing audit/inspection support for case management related activities, including liaising with vendors to provide support as applicable Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes Ensure vendor case processing timelines for AE intake, triage and submission are met Perform retrospective quality assurance of vendor processed cases Day-to-day vendor management issues Interact with other local safety offices as applicable Support on-boarding and off-boarding of vendor staff Attend management meetings with vendors Support analysis of QC trends Support generating, communicating, and archiving of reports of QC findings Support audits of CAPAs and other actions/recommendations for ICSR quality related measures Perform case review as required Generate and distribute performance metrics (retro QA / Case correction) Support analysis of QC trends including actions/recommendations What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master s degree and 3 years of directly related experience (OR) Bachelor s degree and 5 years of directly related experience (OR) Associate s degree and 10 years of directly related experience (OR) High school diploma / GED and 12 years of directly related experience (AND) Previous experience directly managing teams, projects, programs or directing the allocation of resources Preferred Skills: Understanding of global regulatory requirements for pharmacovigilance Proficiency in safety case processing Expertise in all aspects of case intake and processing in multiple global safety databases Experience in supporting inspections or internal audits Communication skills and attention to detail Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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3.0 - 8.0 years

3 - 5 Lacs

Hyderabad

Work from Office

Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support. Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases processed by vendors Ensure Vendors deliver high quality cases through metric management meet all worldwide regulatory authority requirements Provide vendors with resources and training to perform their role Analysis and communication of case Quality Control results Responsible for escalation of case related issues from vendor(s) Providing audit/inspection support for case management related activities, including liaising with vendors to provide support as applicable Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes Ensure vendor case processing timelines for AE intake, triage and submission are met Perform retrospective quality assurance of vendor processed cases Day-to-day vendor management issues Interact with other local safety offices as applicable Support on-boarding and off-boarding of vendor staff Attend management meetings with vendors Support analysis of QC trends Support generating, communicating, and archiving of reports of QC findings Support audits of CAPAs and other actions/recommendations for ICSR quality related measures Perform case review as required Generate and distribute performance metrics (retro QA / Case correction) Support analysis of QC trends including actions/recommendations What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Bachelor s degree and 3 years of directly related experience (OR) Associate s degree and 5 years of directly related experience (OR) High school diploma / GED and 7 years of directly related experience (AND) Previous experience directly managing teams, projects, programs or directing the allocation of resources Preferred Skills: Understanding of global regulatory requirements for pharmacovigilance Proficiency in safety case processing Expertise in all aspects of case intake and processing in multiple global safety databases Experience in supporting inspections or internal audits Communication skills and attention to detail Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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1.0 - 2.0 years

3 - 4 Lacs

Mysuru, Bengaluru

Hybrid

We are hiring!! Open Position : Drug Safety Associate - 1, with a minimum of 1 year experience in case processing. Location : Initially work from home, later will be office based Salary Upto : 4 Lakhs INR per annum Qualifications: Education: Health care professional or Any Equivalent Degree (B pharm/M Pharm/ Pharm D) Experience: 1 to 2 years of experience in PV (Pharmacovigilance) Roles and Responsibilities: As Quality Check Reviewer Review data entered in safety database for completeness and accuracy. Provide quality feedback to team resources Track and maintain quality metrics As Case Processor Responsible for data entry of Individual case safety reports into the safety database. Review and evaluate AE case information to determine required action based on and following internal policies and procedures. Process all incoming cases in order to meet timelines. Full data entry including medical coding and safety narrative. As Medical Coder Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD). As Narrative Writer Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields. Other responsibilities: Following up with sites regarding outstanding queries. Follow up on reconciliation of discrepancies. Follow departmental AE workflow procedures. Closure and deletion of cases. Mentor and guide the activities of the Drug Safety Associate. High level of proficiency al all workflow tasks. Perform any other drug safety related activities as assigned. Specialized knowledge and skills: Basic competence with medical and therapeutic terminology. Ability to work independently but guided by documented procedures, with appropriate support. Able to work effectively as part of a team. Understanding of patient safety regulatory obligations. Should be familiar with regulatory &pharmacovigilance guidelines. Should be familiar with pharmacovigilance terminology. Excellent attention to detail. Ability to deliver within established timelines. Fluency in English and excellent comprehension. Computer literate. Relevant product and industry knowledge. Experience with relevant software applications. Communication skills: Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective crossdepartment communication. Ability to document and communicate problem/resolution and information/action plans. Desired technical skills: Person should be familiar with MS Office Tools. Safety database knowledge. Compliance : Awareness of organizational policies & procedures governing his/her job responsibilities. Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures. Additional Skills Strong motivational skills and abilities, promoting a team-based approach. Strong interpersonal and communication skills, both verbal and written. Strong organizational and leadership skills. Goal-oriente and ability to maintain professional and positive attitude.

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1.0 - 2.0 years

3 - 4 Lacs

Mysuru, Bengaluru

Hybrid

We are currently hiring for DSA I role with a minimum of 1 year experience in case processing. Location : Hybrid Salary Upto : 4 Lakhs INR per annum Essential Duties and Responsibilities: As Quality Check Reviewer Review data entered in safety database for completeness and accuracy. Provide quality feedback to team resources Track and maintain quality metrics As Case Processor Responsible for data entry of Individual case safety reports into the safety database. Review and evaluate AE case information to determine required action based on and following internal policies and procedures. Process all incoming cases in order to meet timelines. Full data entry including medical coding and safety narrative. As Medical Coder Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD). As Narrative Writer Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields. Other responsibilities: Following up with sites regarding outstanding queries. Follow up on reconciliation of discrepancies. Follow departmental AE workflow procedures. Closure and deletion of cases. Mentor and guide the activities of the Dug Safety Associate. High level of proficiency al all workflow tasks. Perform any other drug safety related activities as assigned. Specialized knowledge and skills: Basic competence with medical and therapeutic terminology. Ability to work independently but guided by documented procedures, with appropriate support. Able to work effectively as part of a team. Understanding of patient safety regulatory obligations. Should be familiar with regulatory &pharmacovigilance guidelines. Should be familiar with pharmacovigilance terminology. Excellent attention to detail. Ability to deliver within established timelines. Fluency in English and excellent comprehension. Computer literate. Relevant product and industry knowledge. Experience with relevant software applications. Communication skills: Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective crossdepartment communication. Ability to document and communicate problem/resolution and information/action plans. Desired technical skills: Person should be familiar with MS Office Tools. Safety database knowledge. Other skills: The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines. Compliance : Awareness of organizational policies & procedures governing his/her job responsibilities. Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures. Qualifications Education: Health care professional or Any Equivalent Degree (B pharm/M Pharm/ Pharm D) Experience: 1 to 2 years of experience in PV (Pharmacovigilance) Additional Skills Strong motivational skills and abilities, promoting a team-based approach Strong interpersonal and communication skills, both verbal and written Strong organizational and leadership skills Goal-oriented Ability to maintain professional and positive attitude

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1.0 - 6.0 years

2 - 4 Lacs

Karjat

Work from Office

We are looking for a skilled OT Technician to join our team at Raigad Hospital and Research Centre. The ideal candidate will have 1-6 years of experience in the field. Roles and Responsibility Assist surgeons during surgical procedures and ensure patient safety. Prepare and maintain operating room equipment and instruments for surgery. Monitor patient vital signs and respond to emergencies. Maintain accurate records of patient information and medical history. Collaborate with other healthcare professionals to provide comprehensive care. Participate in ongoing education and training to stay updated on latest techniques and technologies. Job Requirements Strong knowledge of medical terminology and anatomy. Ability to work effectively in a fast-paced environment and prioritize tasks. Excellent communication and interpersonal skills. Ability to maintain confidentiality and handle sensitive information. Familiarity with hospital policies and procedures. Commitment to delivering high-quality patient care and services.

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0.0 - 2.0 years

2 - 5 Lacs

Pune

Work from Office

MedeXCode is looking for Junior Pharmacovigilance Specialist to join our dynamic team and embark on a rewarding career journey Diagnosing and treating illnesses, medical conditions, and injuries. Ordering, performing, and interpreting diagnostic tests. Collecting, recording, and maintaining patients' information and histories. Prescribing and administering treatments, therapies, medications, vaccinations, and other specialized medical care. Explaining procedures and discussing test results or prescribed treatments with patients and family members. Monitoring patients' conditions and progress. Directing, coordinating, consulting with, and referring patients to nurses, students, assistants, specialists, therapists, and other medical staff. Advising patients, parents, and guardians on diets, activities, hygiene, and disease prevention. Conducting research and remaining up to date on current trends, discoveries, and developments in the field

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