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1 - 6 years
10 - 20 Lacs
Pune, Bangalore Rural, Mumbai (All Areas)
Work from Office
Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. • Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Reviewer Mumbai (Job Code # 47) b) For Position in Pune Search : Medical Reviewer Pune (Job Code # 48) c) For Position in Bangalore Search : Medical Reviewer Bangalore (Job Code # 51)
Posted 1 month ago
- 1 years
1 - 4 Lacs
Hyderabad
Work from Office
Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let’s do this. Let’s change the world. In this vital role you will responsible for managing and maintaining laboratory reference ranges in the Electronic Data Capture (EDC) system. This role involves providing subject matter expert advice on laboratory data, reviewing local and central laboratory reference range documents, creating lab IDs, and entering the ranges and units for each analyst into the EDC system. This individual also identifies and helps resolve discrepancies in local laboratory reference ranges. Roles & Responsibilities: Approve new lab parameters, new units, and textbook ranges. Provide subject matter expert advice on laboratory data. Review local and central laboratory reference range documents. Create lab IDs and enter the ranges and units for each analyst into the EDC system. Identify and help resolve discrepancies in local laboratory reference ranges. Communicate and call out day-to-day issues and risks regarding the area of work. Participate in DM and cross-functional working groups. Promote and advocate for data management best practices internally and externally. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications. Basic Qualifications: Master’s degree and 1 to 3 years of life science, computer science, business administration or related discipline or equivalent experience OR Bachelor’s degree and 3 to 5 years of life science, computer science, business administration or related discipline or equivalent experience OR Diploma and 7 to 9 years of [life science, computer science, business administration or related discipline or equivalent experience. 2-4 years of related experience in clinical data management or laboratory coordination. Must-Have Skills: Strong understanding of laboratory data and clinical reference ranges. Knowledge of Good Clinical Practice Understanding of clinical data management processes Understanding of International laboratory unit standards such as the International System of Units (SI) Understanding of concept of conversion factors and comparable results Good-to-Have Skills: Familiarity with electronic data capture (EDC) systems and data management plans (DMP). Understanding of Electronic Health Record (EMR) Systems Understanding of Laboratory Certification Understanding of Laboratory Equipment Calibration Soft Skills: Excellent communication and collaboration skills. Detail-oriented with strong analytical and problem-solving abilities. Ability to work independently and as part of a team. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Posted 1 month ago
3 - 5 years
3 - 4 Lacs
Hyderabad
Work from Office
We are currently hiring for DSA I role with a minimum of 3 to 5 years Of experience in Pharmacovigilance Perform triage & intake of ICSR received daily in ARGUS databases. Ensure data entry of ICSR in ARGUS Knowledge In Aggregate Reporting is Must Required Candidate profile Require 3 to 5 years of pharmacovigilance case processing experience. Responsible for coding events using MEDDRA Any Life Sciences(B pharm/M Pharm/ Pharm D, Life Sciences, Nursing, BDS, BPT)
Posted 1 month ago
1 - 2 years
3 - 4 Lacs
Hyderabad, Pune, Bengaluru
Work from Office
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
Posted 1 month ago
2 - 5 years
6 - 16 Lacs
Bengaluru
Work from Office
Qualification: MBBS Experience: 1 to 3 years Previous experience in medical review of ICSRs. Knowledge of safety databases, such as Argus, ARISg, or similar systems. Familiarity with medical coding dictionaries (e.g., MedDRA) and adverse event reporting standards (e.g., ICH E2B). Strong attention to detail and ability to work with complex medical data. Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders. Key Responsibilities: Individual Case Safety Reports (ICSRs) Review: Conduct thorough and objective medical review of ICSRs received from various sources, including clinical trials, spontaneous reports, and literature. Assess the medical relevance and causality of adverse events reported in ICSRs. Identify and evaluate potential safety signals and perform appropriate follow-up actions as necessary. Ensure accurate and timely reporting of serious and non-serious adverse events to regulatory authorities.
Posted 1 month ago
5 - 10 years
15 - 20 Lacs
Bangalore Rural, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description Perform day to day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in TEST environment, data listing review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of trainings Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 95 b) For Position in Bangalore Search : Job Code # 98
Posted 1 month ago
5 - 10 years
15 - 20 Lacs
Nagpur, Bengaluru, Bangalore Rural
Work from Office
Hi , WE are hiring for Leading ITES Company for SAS Programmer & CDB Programmer ( J Reviewer/Python/SAS) Role & responsibilities: 1.Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 2. Develop library of reusable checks working closely with data engineers and config specialists. 3. Collaborate with cross functional teams in creating business rules and automated check library across TAU. 4. Serves as a technical resource for creating data analytics to help with data validation and cleaning. 5. Provide programming expertise for data cleaning to efficiently ensure high quality data. 6. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 7. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 8. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. 9. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 10. Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 11. Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), 12. EDC build and/or clinical data management experience preferred 13. Experience in AWS preferred 14. Experience setting up automated validation is preferred 15. Knowledge of Data lake and creating interactive Dashboards are preferred 16. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Nagpur Search : SAS + CDB Programmer Nagpur (Job Code # 85) b) For Position in Bangalore Search : SAS + CDB Programmer Bangalore (Job Code # 86)
Posted 1 month ago
3 - 8 years
10 - 15 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 54 b) For Position in Pune Search : Job Code # 55
Posted 1 month ago
4 - 9 years
11 - 21 Lacs
Nagpur, Pune, Mumbai (All Areas)
Work from Office
We are Hiring for Leading ITES Company for Medical Reviewer Profile Pls Apply, We shall call back the relevant profiles. Experience :- Min 1 years of experience in Medical Reviewer domain Job Description for Medical Reviewer Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. • Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. • Ensure compliance with global and local procedural documents and local implementation of client. Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 47 b) For Position in Pune Search : Job Code # 48 c) For Position in Nagpur Search : Job Code # 49
Posted 1 month ago
0 - 12 years
0 Lacs
Kolkata, West Bengal, India
On-site
We are looking for Medical Science Liaison- Oncology for a Global Pharmaceutical MNC. Position: Medical Science Liaison- OncologyQualification: MBBS/ MD PharmacologyExperience: Minimum 6 months of experience in Oncology as MSL/RMA (Freshers with MD Pharmacology degree can apply too)Location:Kolkata / Delhi Job Purpose:The Medical Science Liaison (MSL) will establish the company’s medical affairs presence with external stakeholders through scientific exchange and research support in oncology. The focus will be on licensed and non-licensed products for hard-to-treat cancers, including metastatic pancreatic cancer, cholangiocarcinoma, digestive cancers (such as stomach cancer, pancreatic cancer, and cholangiocarcinoma), glioma, brain tumors, hematologic cancers (acute myeloid leukemia, acute lymphoblastic leukemia, and lymphoma), and pediatric cancers. This role is field-based, covering the India region.The MSL will communicate balanced therapeutic area-related, product-related, and clinical information to external stakeholders (e.g., physicians, academic institutions, hospital formulary committees), respond to unsolicited requests for medical information, facilitate research discussions, and bring key insights from the medical and scientific community to internal stakeholders. The role also involves ensuring compliance with all company procedures, confidentiality standards, and contributing to business success with a focus on patient safety. Principal Accountabilities:1. Exchange of Medical and Scientific Information:Responsible for communicating fair and balanced therapeutic area-related, product-related, and clinical information to external stakeholders.Execute the scientific engagement plan in alignment with the Therapy Medical Plan.Proactively develop long-term peer-to-peer relationships with opinion leaders and relevant stakeholders.Respond to unsolicited requests for medical information, including off-label data, related to marketed products and pipeline products.Provide clinical and medical presentations to external stakeholders as needed.Disseminate updates from scientific meetings and report information of strategic interest to cross-functional teams.2. Supporting Clinical Research:Support ongoing and future Medical Affairs Company-Sponsored Studies, providing country-level review of proposed research site lists, attending site visits if necessary, and providing feedback to the line manager.Support unsolicited requests for investigator-initiated trials (IITs) proposals by offering appropriate investigator support as per company SOPs.Assist in the development and support of national disease registries and Real-World Evidence (RWE) projects as necessary.3. Contributing to the Organization through Medical Expertise & Market Insights:Maintain up-to-date knowledge of scientific/medical developments in the relevant therapeutic area through literature searches, clinical papers, conferences, and other relevant events.Capture and share in-field insights to develop territorial Field Medical Plans and support medical and scientific strategies.Provide medical and scientific expertise to commercial partners within regulatory guidelines.Act as a field-based scientific and clinical reference for internal stakeholders (e.g., sales, market access) through training and ad-hoc support.4. Cross-Functional Collaboration:Support the development of medical/scientific materials, ensuring content is reviewed and approved according to company policies.Contribute to the development and execution of the regional medical affairs strategy and action plan in collaboration with field departments such as Sales, Clinical Research, and Market Access.Keep medical representatives and their managers informed about the latest scientific developments.Support the market access strategy at a regional level, including hospital listings, in coordination with the market access manager.5. Compliance with External Regulations and Company Policies:Maintain a high level of scientific, clinical, and environmental knowledge through courses, self-learning, and attendance at relevant meetings.Stay informed about regulations related to medical information services in the pharmaceutical industry.Ensure all activities comply with internal and external codes of conduct, prioritizing patient safety by following pharmacovigilance processes.Support the company’s reputation in the field by adhering to industry regulations.6. Patient-In Activities:Support patient awareness initiatives, both physical and digital.Contribute to the Patient-In strategy, understanding the patient journey in coordination with therapeutic area experts, and set up Patient Support Programs (PSPs) to improve patient outcomes as per local regulations.General Administration:Complete all required administration within the specified timelines.Submit monthly reports and expenses by the second working day of each month.Ensure timely completion and submission of all required documentation to the Head Office as appropriate.Profile RequirementsA] Minimum Requirements:Education: MBBS/MDMinimum 1-2 years of working experience in oncology.B] Indispensable Qualities:Strong ability to learn new subjects and environments comprehensively.Excellent written and spoken communication and presentation skills, with the ability to build and maintain collaborative relationships with opinion leaders, physicians, and other healthcare decision-makers.Substantial business acumen and autonomy in managing priorities and activities.Strong commitment to compliance with relevant rules and procedures, as well as scientific integrity and quality.Ability to manage cross-functional projects effectively.Leadership skills, emotional intelligence, active listening, and strength of conviction.Negotiation and problem-solving abilities.Proficiency in English is essential.Ability to innovate and execute strategies effectively. Relevant candidates can share their CV at pooja.j@domniclewis.com
Posted 1 month ago
10 - 15 years
18 - 22 Lacs
Navi Mumbai
Work from Office
Key Responsibilities: 1. Serve as a Responsible person for Pharmacovigilance officer in-charge (PvOI) for organization. 2. Developing Pharmacovigilance (PV) training modules and organizing PV training for PV team members and other relevant staff. 3. Collection of AE reports and other pharmacovigilance relevant data. 4. Management of PV database. 5. Ensuring the necessary quality, including the correctness and completeness of pharmacovigilance data. 6. ICSR processing specifically reviewing MedDRA coding of data, assessment in terms of diagnosis and/or seriousness, Causality and seriousness assessment. Monitoring timely submission to regulatory authority. 7. Literature search to identify relevant adverse event cases. 8. Preparation/review of contractual arrangements with other persons/organizations with regards to pharmacovigilance obligations 9. SDEA initiation with new parties and renewal. 10. Assessing safety data and proposing risk minimization measures. 11. Preparation/update/review of SOPs, PSURs, RMPs, contractual agreements etc. 12. Review of compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance.
Posted 1 month ago
2 - 5 years
19 - 21 Lacs
Bengaluru
Work from Office
Overview We have an exciting role of Medical Writer to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies. Responsibilities Lead and manage a team, providing guidance, mentorship, and support to ensure their professional growth and enhance the quality of output Develop a refined understanding of the brand, disease, and the overall therapeutic/treatment category. Ensure all content is created with appropriate tone, style, and structure based on brand strategy, creative brief, and client expectations Demonstrate a sound understanding of healthcare/pharmaceutical advertising communication requirements Ability to understand appropriate medical/technical documents (clinical studies, product monographs, publications) and translate them into compelling messages and content for a wide variety of audiences Demonstrate superior writing skills and a high level of professional craftsmanship (referencing, annotating) Familiar with modular content and omnichannel marketing - the ability to develop and maintain content matrix and core claims documentation Play the role of a leader when managing a team, exhibit leadership skills and motivate them when required Demonstrate ability to set priorities while handling multiple tasks Keep track resource allocation, and project progress, providing regular updates and reports to management Collaborate with clients and account managers to address feedback, incorporate changes, and ensure client satisfaction Manage multiple projects simultaneously, allocating resources effectively and maintaining effective communication with cross-functional teams and clients Conduct performance evaluations, identify training needs, and provide professional development opportunities for the design team Qualifications 11+ years of experience in healthcare communications agencies (AMA experience is preferred) Bachelor's degree or equivalent experience with a focus on pharma/science/medicine Portfolio containing work samples that demonstrate medical writing for a variety of communication forms (e.g., sales aids, direct mail, websites, social media) for a variety of audiences (e.g., healthcare professionals, patients, consumers) AMA Style Guide knowledge (certification not mandatory) Experience with referencing and annotating, and client MLR submissions requirements An ability to understand and process healthcare information Able to multi-task in a faced paced environment as a member of a highly collaborative team The desire to work with a diverse group of teams, projects, and clients Strong conceptual ability, standout creative thinking, and top-notch writing skills
Posted 1 month ago
2 - 4 years
7 - 10 Lacs
Bengaluru, Hyderabad, Mumbai (All Areas)
Work from Office
Hi We are looking to hire Narrative Medical Writers for our Client. Please go through the JD and Apply Role : Graduate or post graduate in Pharmacy, Nursing or life sciences. Certification in Medical writing or Diploma in clinical research would be desirable. Preferred experience for the Author role: Preferably 1 to 2 years of experience in medical writing domain. Life science graduate with 1 to 3 years of experience Responsibilities of Author: 1. As per process requirement and assigned primary responsibility, support CSR patient narratives (draft and QC) 2. Ensure that the narratives are in accordance with the client SOPs, guidelines and agreed timelines and comply with client quality standards 3. Perform Quality check of the narratives according to the project specific checklist and against the source documents such as patient listing, concomitant medication listing, CIOMS form etc. and log defect in the defect tracker after analyzing the defect category 4. Attention to detail, work under stringent timelines on a need basis, and switch between different projects, as required 5. Be responsible for the quality and timelines of the deliverables as designated/allocated in the project. 6. Proactive communication with lead narrative writers to meet the narrative writing quality and timelines 7. Complete assigned training within stipulated timelines 8. Provide timely data (study tracker, quality metrics, billing numbers/effort hours) for preparing relevant (e.g. quality, TAT, effort hours, etc.) and project status updates, as defined by the client requirements To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 365 b) For Position in Bangalore Search : Job Code # 366 c) For Position in Hyderabad Search : Job Code # 367
Posted 1 month ago
1 - 3 years
6 - 10 Lacs
Noida
Work from Office
Hi, We are hiring for leading ITES Company for Narrative Medical Writing Profile . Job Description Graduate or post graduate in Pharmacy, Nursing or life sciences. Certification in Medical writing or Diploma in clinical research would be desirable. Preferred experience for the Author role: Preferably 1 to 2 years of experience in medical writing domain. Life science graduate with 1 to 3 years of experience Responsibilities of Author: 1. As per process requirement and assigned primary responsibility, support CSR patient narratives (draft and QC) 2. Ensure that the narratives are in accordance with the client SOPs, guidelines and agreed timelines and comply with client quality standards 3. Perform Quality check of the narratives according to the project specific checklist and against the source documents such as patient listing, concomitant medication listing, CIOMS form etc. and log defect in the defect tracker after analyzing the defect category 4. Attention to detail, work under stringent timelines on a need basis, and switch between different projects, as required 5. Be responsible for the quality and timelines of the deliverables as designated/allocated in the project. 6. Proactive communication with lead narrative writers to meet the narrative writing quality and timelines 7. Complete assigned training within stipulated timelines 8. Provide timely data (study tracker, quality metrics, billing numbers/effort hours) for preparing relevant (e.g. quality, TAT, effort hours, etc.) and project status updates, as defined by the client requirements Key Skills: a) Grad or PG in Nursing, Pharmacy or Life Sciences b) 1 to 2 years of experience in medical writing To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Noida Search : Copy and Paste the link below https://outpace.in/job/narrative-medical-writing-4/
Posted 1 month ago
8 - 12 years
12 - 22 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi We are looking forward to hire Medical Monitor for our Client. Please go through the JD and Apply Responsibilities: Review protocol and provide suggestions Respond to queries/ clarifications from EC/ IRBs Answer medical questions from sites or project team Respond to queries from sites with regard to protocol Attend drug safety meetings/ external meetings Patient eligibility review Review AE/ SAEs Protocol training to site staff, CRAs etc Attend, participate/ present in investigator meetings Qualification: MBBS/ MD qualification Eligibility: 3 year+ of clinical trial experience Familiar with clinical trials operations Good English communication skills Proficiency in using Microsoft office To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 362 b) For Position in Pune Search : Job Code # 363 c) For Position in Bangalore Search : Job Code # 364
Posted 1 month ago
0 - 1 years
1 - 2 Lacs
Coimbatore
Work from Office
Basic Section No. Of Openings 2 Grade 1A Designation Trainee Coder Closing Date 16 May 2025 Organisational Country IN State TAMIL NADU City COIMBATORE Location Coimbatore-II Skills Skill Healthcare Medical Coding Biotechnology Microbiology CPT Medical Billing Molecular Biology GMP HIPAA Biochemistry Education Qualification No data available CERTIFICATION No data available About The Role Role Description Overview: Trainee Coder is accountable to manage day to day activities of coding the patients chart & diagnosis report. Responsibility Areas: To review emails for any updates Updating/Clearing the production/pending reports Other miscellaneous work that requires coding expertise Coding or auditing charts, based on requirements Prepare and Maintain status reports. Understand the client requirements and specifications of the project Meet the productivity targets of clients within the stipulated time. Ensure that the deliverables to the client adhere to the quality standards.
Posted 1 month ago
0 - 2 years
0 - 0 Lacs
Chandigarh, Chandigarh
Work from Office
Qualification – B. Pharma/M.Pharma Minimum Experience – 5 years Job description 1. Administrative and Managerial Duties: Supervise pharmacy staff (pharmacists, technicians, assistants). Develop and implement departmental policies and procedures. Ensure compliance with regulations (NABH Guidelines). Oversee inventory management of drugs and supplies. Manage budgeting and procurement for the pharmacy department. Coordinate with other departments for interdisciplinary care. 2. Clinical and Operational Oversight: Ensure the safe, accurate, and timely dispensing of medications. Supervise compounding, labeling, and storage of medications. Participate in or oversee clinical pharmacy services, like: Drug utilization reviews, Medication reconciliation and Therapeutic drug monitoring Guide the implementation of antibiotic stewardship programs 3. Quality Assurance and Compliance: Monitor drug safety and pharmacovigilance activities. Conduct or facilitate internal audits and support external inspections. Ensure proper documentation and reporting. Enforce proper disposal of expired or unused medications. 4. Training and Development: Organize continuing education and training for pharmacy staff. Mentor junior pharmacists and pharmacy interns. Stay updated with latest pharmaceutical practices and encourage the same in the team. 5. Coordination and Communication: Liaise with hospital administration, clinicians, and nursing staff to optimize patient care. Act as a representative in hospital committees (e.g., Drug and Therapeutics Committee). Handle patient and doctor complaints related to medication services. Requirement: We are seeking a highly organized and detail-oriented Pharmacy Purchasing Officer with proven experience in managing pharmaceutical procurement. The ideal candidate will have in-depth knowledge of pharmaceutical products, excellent negotiation skills, and the ability to maintain optimal stock levels while ensuring cost-effectiveness and compliance with regulations. Job Type: Full-time Pay: ₹35,000.00 - ₹40,000.00 per month Schedule: Rotational shift Supplemental Pay: Yearly bonus Ability to commute/relocate: Chandigarh, Chandigarh - 160022, Chandigarh: Reliably commute or planning to relocate before starting work (Preferred) Education: Bachelor's (Preferred) Experience: Basic computer: 2 years (Required) total work: 4 years (Required) Pharmacist: 2 years (Required) Language: Hindi (Preferred)
Posted 1 month ago
0 - 2 years
0 Lacs
Bengaluru, Karnataka
Remote
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Role Summary: MSL embody our medical mission in becoming a trusted, agile partner who engages in relevant dialogue and delivers timely, high impact data and insights that advance the science or accelerate access, optimise medical practice and drive appropriate adoption of BMS medicines. The MSL role is a field-based role. It is anticipated that a MSL will spend a minimum of 60-70% of their time in the field with external customers. The primary role of MSL is to develop and maintain contacts with Thought Leaders (TL) and Healthcare Providers (HCP) within their healthcare system. The purpose of interactions is to ensure patients have access to BMS medicines, to ensure their safe and appropriate use through peer-to-peer discussions aligned with medical strategies and needs expressed by the stakeholders. The scientific dialogue focuses on scientific/clinical information around disease management and BMS products in a fair and balanced way and includes appropriate Health Economics and Outcomes Research (HEOR) data. Key Responsibilities External Environment and Customer Focus Develop and maintain interactions with Thought Leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions. MSLs will use various channels for interactions (1:1, group presentation; remote, etc). Develop and execute a medical interaction plan with Key accounts (Army, Railways, CGHS etc.) as per the needs of the stakeholders and the overall medical strategy. Effectively present information to HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives. Actively assess the medical landscape by meeting with Thought Leaders to understand their needs and expertise. Continuously update their own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers. Collect and provide meaningful medical insights back to the medical and commercial organizations to be actioned in support of the strategy development. Report safety information, including adverse events, in accordance with BMS Standard Operating Procedures. Contribute to the Country Medical Plan Develop territory Field Medical plan and TL Interaction plans based on therapeutic area objectives and TLs needs. Execute certain medical plan activities as assigned. Adopt institution/account planning approach and contribute to cross-functional institution/account plans. Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan. Provide Medical Support As necessary and appropriate, support the initial and ongoing medical/scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Market Access). Provide scientific support at promotional meetings by presenting unbiased scientific and clinical data, by evaluating speakers and by giving support to BMS-contracted speakers. Support Clinical Trial Activities Support Interventional and Non-Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to support patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with local medical management and as defined by the study scope document. Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with local medical management. Actively support CRO sponsored studies as agreed with local medical management and as defined by the study scope document. Support HCPs in the ISR submission process as agreed with local medical management. Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events. Contribute towards the Patient advocacy programs Support the implementation of the patient education programs in collaboration with the patient advocacy groups. Support the creation of patient education materials. Report safety information, including adverse events, in accordance with BMS Standard Operating Procedures Qualifications MBBS, MD, BDS, MDS 1-2 years of Field Medical experience in medical affairs is preferred. Candidates with experience in the Oncology and Haematology therapy area will be preferred. Languages Excellent English language skills - spoken and written. Experience And Knowledge Working in a scientific and/or clinical research environment Ability to work independently and act as a team player. Have an innovative mindset and approach. Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients. Good communication and presentation skills to present scientific and/or clinical data to research or healthcare professionals Developing peer-to-peer relationships with TLs, scientists and other healthcare professionals Ability to quickly and comprehensively learn about new subject areas and environments. Disease area knowledge and an understanding of scientific publications Knowledge of clinical trial design and process Knowledge of the national healthcare and access environment Knowledge of HEOR core concepts (Health economic and outcome research) is a plus. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Posted 1 month ago
3 - 8 years
10 - 15 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines b) Qualifications - Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 54 b) For Position in Pune Search : Job Code # 55
Posted 1 month ago
0.0 years
0 Lacs
Chandigarh
On-site
Work With Us! A leading contract research organization trusted by leaders CONTINUUM employs scientists and physicians for performing activities in the domains of Pharmacovigilance, Regulatory, Evidence Evaluation and Technology. Please write to us at careers@continuumindia.com and we would reach out to you, if your resume is found to be suitable Drug Safety Physician - Position Code: DSP001 Location: Chandigarh Report preparation [e.g. Periodic Benefit Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, US Periodic Adverse Drug Experience Reports (PADERs)] from aggregate data for products, in accordance with client conventions and requirements; Quality checks of aggregate reports; Signal detection-related analyses and reports including cumulative analyses, issue event analyses, Signal Evaluation Reports/ Drug Safety Reports , review of published literature and case listings; Vigilance over important/designated medical events; Interaction with client personnel to discuss potential signals and issues detected with products; Support preparation and maintenance of Risk Management Plans (RMPs); Follow-up and interaction with clients to obtain incomplete/missing information, with a view to resolving and clarifying issues; Performing medical review of individual case safety reports (ICSRs); Performing medical review of narratives for Clinical Study Reports (CSRs); Providing medical advice to drug safety scientists to assist them with processing of ICSRs and CSR narratives; Maintaining an excellent knowledge of the adverse event safety profile of assigned drugs, labelling documents, and client guidelines and Standard Operating Procedures (SOPs); Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for report submissions; Maintaining records in compliance with guidelines and SOPs. Minimum qualification (s): A degree in Medicine (MBBS) or a post-graduation qualification (MD), preferably in a clinical branch; Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text; Ability to evaluate and interpret data, draw conclusions independently and synthesize scientific data; Fluency in written and spoken English; Proficiency in computer skills in Windows 10/ Windows 7 Operating system and the MS office suite (Word/Excel/Powerpoint) and an ability to work with web-based applications; Typing and transcription accuracy; Attention to detail. Note: : Ayurvedic, homeopathic, veterinary doctors or from other alternative medical streams and scientists with life sciences background need not apply for this position.
Posted 1 year ago
0.0 years
0 Lacs
Chandigarh
On-site
Work With Us! A leading contract research organization trusted by leaders CONTINUUM employs scientists and physicians for performing activities in the domains of Pharmacovigilance, Regulatory, Evidence Evaluation and Technology. Please write to us at careers@continuumindia.com and we would reach out to you, if your resume is found to be suitable Pharmacovigilance Scientist - Position Code: PVS001 Location: Chandigarh Manage activities relating to the processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed and investigational human and veterinary products in accordance with the applicable regulatory requirements. Aggregate report preparation [e.g. Periodic Benefit Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, US Periodic Adverse Drug Experience Reports (PADERs)] from aggregate data for products, in accordance with client conventions and requirements; Quality checks of aggregate reports; Signal detection-related analyses and reports including cumulative analyses, issue event analyses. Minimum qualification (s): Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology or Biophysics) or a degree in Dentistry or Bachelor degree in Veterinary Sciences (B.V.Sc.) or Post-Graduation in Veterinary Sciences (M.V.Sc.); experience in the Pharmacovigilance industry would be an advantage. Good knowledge of medical terminology, fluency in written and spoken English, computer proficiency, an ability to work with web-based applications, and familiarity with the Windows 10/ Window 7 professional operating system and the MS Office suite (Word/Excel/Power Point), capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text, ability to evaluate data and draw conclusions independently, strong written and oral communications skills are required.
Posted 1 year ago
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Pharmacovigilance, also known as drug safety, is a crucial aspect of the healthcare industry that focuses on monitoring and assessing the safety of pharmaceutical products. In recent years, there has been a growing demand for pharmacovigilance professionals in India as the pharmaceutical sector continues to expand. Job seekers looking to explore opportunities in pharmacovigilance in India can expect a competitive job market with promising career prospects.
These cities are known for their concentration of pharmaceutical companies and research institutions, making them hotspots for pharmacovigilance job opportunities.
The average salary range for pharmacovigilance professionals in India varies based on experience and location. Entry-level positions typically start at around INR 3-5 lakhs per annum, while experienced professionals can earn upwards of INR 10-15 lakhs per annum.
In pharmacovigilance, a typical career progression may include roles such as Drug Safety Associate, Drug Safety Specialist, Pharmacovigilance Scientist, Pharmacovigilance Manager, and Pharmacovigilance Director. As professionals gain experience and expertise, they may move into leadership positions with increased responsibilities.
In addition to pharmacovigilance expertise, professionals in this field are often expected to have knowledge of regulatory guidelines, data analysis skills, medical terminology, and effective communication abilities.
As you prepare for pharmacovigilance job opportunities in India, remember to showcase your expertise, relevant skills, and passion for drug safety. Stay updated with industry trends and regulations, and approach interviews with confidence. With the right preparation and determination, you can embark on a rewarding career in pharmacovigilance in India. Good luck!
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