410 Drug Safety Jobs

Job Description ob Post: Pharmacologist Manipal Hospitals, Kharadi, Pune Department: Medical Services Manipal Hospitals, Kharadi, Pune seeks a Pharmacologist to optimize drug therapy and ensure patient safety. Mandatory Skills Pharmacology, Clinical Pharmacology, Drug Safety, pharmacy, healthcare Location Pune Roles & Responsibilities Responsibilities: Provide expert consultation on drug use. Develop drug protocols. Conduct pharmacokinetic/dynamic studies. Monitor drug effectiveness/safety. Provide pharmacology education. Conduct drug research. Collaborate with pharmacy. Participate in relevant committees. Stay updated on pharmacology. Qualifications: D Pharma 3+ years hospital experience. Strong knowledge of clinical pharmacology, pharmacokinetics, and pharmacodynamics. Excellent communication and problem-solving skills. Ability to work in a multidisciplinary team. Commitment to patient safety and quality care. Research/publication experience desirable.

Aster Medcity is looking for Pharmacist Pharmacy to join our dynamic team and embark on a rewarding career journey Reviewing and interpreting prescription ordersPreparing and dispensing medicationsAdvising patients on the safe and effective use of their medications, including potential side effects and interactionsMonitoring patients for adverse reactions and ensuring that any necessary changes to their medication regimen are made in a timely mannerKeeping accurate and up-to-date records of patients' medication history and any adverse reactionsCollaborating with other healthcare professionals to provide comprehensive care to patientsStaying current on developments in the field of pharmacology and medication therapy

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.

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

We are looking for a highly skilled and experienced Medical Director/Senior Consultant to lead our Oncology department at Benovymed Healthcare Private Limited. The ideal candidate will have 5-30 years of experience in the field. Roles and Responsibility Provide high-quality patient care and treatment in oncology. Lead and manage a team of healthcare professionals to achieve optimal outcomes. Develop and implement effective treatment plans for cancer patients. Collaborate with other departments to ensure comprehensive care. Stay updated with the latest medical research and advancements in oncology. Mentor and train junior staff members to enhance their skills. Job Requirements Strong knowledge of oncology and cancer treatment options. Excellent leadership and management skills. Ability to work effectively in a fast-paced environment. Strong communication and interpersonal skills. Ability to make sound decisions under pressure. Commitment to delivering high-quality patient care.

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

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

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

We are looking for a highly skilled and experienced Pharmacist to join our team at MAX Hospital in Noida. The ideal candidate will have 3 to 8 years of experience in the pharmaceutical industry, with a strong background in pharmacy practice. Roles and Responsibility Dispense medications to patients and provide counseling on their proper use. Manage inventory and maintain accurate records of prescriptions and dispensing activities. Collaborate with healthcare professionals to develop and implement medication therapy plans. Conduct patient assessments and monitor their response to medication therapy. Develop and implement pharmacy protocols and procedures. Participate in quality improvement initiatives to enhance patient care and safety. Job Requirements Hold a degree in Pharmacy (D.Pharm, B.Pharm, M.Pharm) from a recognized institution. Possess a minimum of 3 years of experience in pharmacy practice, preferably in a hospital setting. Demonstrate strong knowledge of pharmaceuticals, medications, and medical terminology. Exhibit excellent communication and interpersonal skills. Ability to work effectively in a fast-paced environment and prioritize tasks is essential. Strong analytical and problem-solving skills are required.

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

About The Role Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical data SVS Analyst Qualifications: Any Graduation,BE,MCA Years of Experience: 3-5 Yrs 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.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement What are we looking for Clinical Database ProgrammingClinical Data ManagementOracle Procedural Language Extensions to SQL (PLSQL)Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to work well in a teamSAS ClinicalStructured Query Language (SQL 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 Any Graduation,BE,MCA

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.

Pharmacovigilance Reporting Specialist - Hybrid - Sofia, Bulgaria We are currently seeking a Pharmacovigilance Reporting Specialist to join our diverse and dynamic team. As a Pharmacovigilance Reporting Specialist at ICON, you will be responsible for the timely and accurate preparation of pharmacovigilance reports, ensuring compliance with regulatory requirements and internal policies. Your expertise in data analysis and reporting will be crucial in supporting the organization s commitment to drug safety and patient well-being. The role is 60% office-based in Sofia, Bulgaria or Warsaw, Poland and requires approx. 3 days/week office presence. What You Will Be Doing: Preparing and submitting comprehensive safety reports, including periodic safety update reports (PSURs) and individual case safety reports (ICSRs), in compliance with regulatory standards. Conducting thorough data analysis to identify trends and assess the safety profile of pharmaceutical products. Collaborating with cross-functional teams to ensure timely and accurate reporting of adverse events. Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices to ensure compliance. Providing training and support to team members on pharmacovigilance reporting processes and requirements. Your Profile: Bachelors degree in life sciences, pharmacy, or a related field; advanced degree preferred. Significant (4+ years) experience in pharmacovigilance reporting or drug safety within a clinical or pharmaceutical environment. Project lead experience is required. Strong analytical skills with proficiency in data analysis tools and reporting software. Excellent communication and interpersonal skills, facilitating effective collaboration with internal and external stakeholders. A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities. Excellent command in English. #LI-Hybrid #LI-MK2 Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Pharmacovigilance Reporting Specialist - Hybrid - Sofia, Bulgaria ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Pharmacovigilance Reporting Specialist to join our diverse and dynamic team. As a Pharmacovigilance Reporting Specialist at ICON, you will be responsible for the timely and accurate preparation of pharmacovigilance reports, ensuring compliance with regulatory requirements and internal policies. Your expertise in data analysis and reporting will be crucial in supporting the organization s commitment to drug safety and patient well-being. The role is 60% office-based in Sofia, Bulgaria or Warsaw, Poland and requires approx. 3 days/week office presence. What You Will Be Doing: Preparing and submitting comprehensive safety reports, including periodic safety update reports (PSURs) and individual case safety reports (ICSRs), in compliance with regulatory standards. Conducting thorough data analysis to identify trends and assess the safety profile of pharmaceutical products. Collaborating with cross-functional teams to ensure timely and accurate reporting of adverse events. Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices to ensure compliance. Providing training and support to team members on pharmacovigilance reporting processes and requirements. Your Profile: Bachelors degree in life sciences, pharmacy, or a related field; advanced degree preferred. Significant (4+ years) experience in pharmacovigilance reporting or drug safety within a clinical or pharmaceutical environment. Project lead experience is required. Strong analytical skills with proficiency in data analysis tools and reporting software. Excellent communication and interpersonal skills, facilitating effective collaboration with internal and external stakeholders. A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities. Excellent command in English. #LI-Hybrid #LI-MK2 What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles.

Division Department Sub Department 1 Job Purpose Submit product documents to regulatory authorities in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and handle post-approval changes, maintenance, and updation of documents during the products life-cycle Key Accountabilities (1/6) Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time Co-ordinate with cross-functional teams and external stake-holders for query response discussion and distribute updated work plan *Create DMF master in LoA software & issue LoAs/CEPs Verify pre-approved documents Leverage product gap analysis #Preparation compilation and submission of the dossier documents / deficiency responses to agency as per the region specific requirements(for Para-IV -US) Preparation of M1 documents, and collate the dossier/ deficiency responses package/DMF received from CDT and submit to the regulatory authority/customer Submit online audit dossier/DMF along with queries Key Accountabilities (2/6) Submit post approval variations for changes that improves productivity, cost-effectiveness, quality of the product by reviewing, collating, compiling the variation application to meet the delivery within timelines and maintain Product Marketing Authorization, Renewals/Sunset clause to ensure continuous validity of marketing authorisations. Verify pre-approved documents/variation packages as received from LCM Prepare M1 documents, and collate variation packages and annual report packages received from LCM team and submit to the regulatory authority/customer Check for the MA business interest from stakeholders and progress with the renewal/ sunset clause filing Prepare labelling submission package to be in-line with RLD labelling updates and submit to the authority Prepare SPL and Drug listing for customer/launch products Key Accountabilities (3/6) Maintain, and update product dossier as required to meet changes in Cipla s internal systems, changes in regulatory guidelines, and to meet the need of regulatory requirements Review DMF and resolve discrepancies (if any) in co-ordination with CFTs Evaluate proposals related to changes (Facility change con/Notifications) and conveying line of action to manufacturing unit/relevant stakeholders. Update the database (PRC/SAP-RA/ table) associated with product dossier approvals by including registration details in database. *Attend launch meetings with internal and external stake-holders *Updating tracker for DMF number assigned by Regulatory Health Agencies and maintain the relevant data base (LOA software) upto date Notify cross-functional teams and external stake-holders about the approvals and approved documents Include and update registration details in databases (PRC/SAP-RA table/) # Provide details for APQR compilation Key Accountabilities (4/6) Provide Regulatory support throughout the life cycle of the product for smooth functioning Provide the approved product information (labelling) and the relevant documents as requested by the drug safety or quality teams Confirm product list and MA details for finalization of TA Provide the information on the suitability and availability of dossier for out-licensing and in-licensing Check the dossier information for due-diligence Perform drug listing and review labelling Key Accountabilities (5/6) Check with regulatory authorities (EU, NZ & TGA) for submission activity and approval status for submission done Check with authorities for safe receipt of submitted DMF/documents as and when required Communicate to authorities for regulatory support/data requirement to get approvals Maintaining the acknowledgement letters/deficiency letters received from Regulatory Health Agency Key Accountabilities (6/6) Major Challenges Delay in the availability of the documents from cross functional teams - leads to inadherence to target deadlines Changing regulatory environment, constant updates in the regulations-leads to rework and inadherence to target deadlines Change proposals affecting dossier sections leads to leads to rework and inadherence to target deadlines Inefficient software-leads to inadherence to target deadlines Key Interactions (1/2) RnD team (for formulation clarity-need basis) Manufacturing Unit-QA/QC/Production for documents procurement -daily Packaging Team (for procurement labelling documents - dailly) CPM, BD & Supply chain - for routine commercial/launch clarity (weekly basis) PV - for product approval notification and audit support (daily) Patent Team -to get the clarity on product patent and exclusivity (need basis) Key Interactions (2/2) Customers - product related queries / additional information required by customers and status updates- (daily) Regulatory consultants - submissions, queries, status (weekly) Software provider - trouble shooting (need basis) Health authorities- follow up- seek advice (need basis) Dimensions (1/2) Issuance of LoAs/CEPs: Approx. 100/Month Submission of DMFs to authorities: Approx. 14/Month Submission of AP DMFs to customer: Approx. 12/Month Legalization of documents: Approx. 20 documents /Month Dimensions (2/2) Key Decisions (1/2) Classification and type of change category for moderate and major changes confirm with group leader Key Decisions (2/2) Education Qualification B.Pharmacy, M. Pharm, Bsc or MSc Relevant Work Experience Minimum 5 years experience in regulatory activity in pharma industry preferably worked for same region/authority. Hands-on experience of eCTD submission

JD: Serve as the company s subject matter expert on drug safety and pharmacovigilance Ensure compliance with Local & Global PV-relevant Heath Authority requirements Oversee PV Contracts, vendor management and PV system audits/inspections Have good understanding of signal management and benefit-risk evaluation activities Develop and implement Risk Management Plans (RMPs) and additional Risk mitigation measures Act as the primary safety liaison with country regulatory authorities and internal stakeholders Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and Quality Assurance, marketing teams etc. Contribute to clinical trial safety strategies and protocols (e.g., protocols, safety monitoring plans, SAE reporting etc.) Mentor and develop PV team members to maintain a culture of continuous improvement and compliance Manage departmental budgets, staffing, and resourcing in line with organizational needs Qualifications: Advanced degree in Medicine or Pharmacy Minimum 10 years of progressive pharmacovigilance experience in the pharmaceutical industry In-depth understanding of Local/global PV regulations and guidance Demonstrated experience in leadership roles with proven ability to build and scale PV systems. Strong analytical, strategic thinking, and communication skills. JOB FAMILY: Product Development LOCATION: India > Mumbai : BKC Building t SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Job Title : Pharmacovigilance Specialist Location : Bangalore / Hyderabad Experience : Minimum 4 Years in PV ICSR Job Summary We are seeking a skilled and detail-oriented Pharmacovigilance (PV) Specialist with hands-on experience in Individual Case Safety Reports (ICSR) . The ideal candidate will be responsible for end-to-end case processing and ensuring compliance with global PV regulations and internal SOPs. Key Responsibilities : Perform case intake, triage, data entry, quality review, and submission of ICSRs. Evaluate and code adverse event reports using MedDRA and WHO-DD coding. Ensure timely reporting of adverse events to regulatory authorities and clients. Maintain compliance with pharmacovigilance regulations (e.g., FDA, EMA, CDSCO). Collaborate with cross-functional teams to ensure accurate and complete safety data. Contribute to audit and inspection readiness. Prepare periodic safety update reports (PSURs) and other regulatory documents when required. Qualifications : Bachelors or Masters degree in Pharmacy, Life Sciences, or related field. Minimum 4 years of hands-on experience in PV ICSR processing. Strong understanding of global PV regulations and ICH-GCP guidelines. Familiarity with PV databases (e.g., Argus, ArisG) is an advantage. Excellent attention to detail and strong analytical skills. Good communication and documentation skills. Preferred Attributes : Certification in Pharmacovigilance will be an added advantage. Ability to work independently and as part of a team. Willingness to work in shifts if required (based on client/region).

Job Title : Pharmacovigilance Specialist Location : Bangalore / Hyderabad Experience : Minimum 2 Years in PV ICSR Job Summary We are seeking a skilled and detail-oriented Pharmacovigilance (PV) Specialist with hands-on experience in Individual Case Safety Reports (ICSR) . The ideal candidate will be responsible for end-to-end case processing and ensuring compliance with global PV regulations and internal SOPs. Key Responsibilities : Perform case intake, triage, data entry, quality review, and submission of ICSRs. Evaluate and code adverse event reports using MedDRA and WHO-DD coding. Ensure timely reporting of adverse events to regulatory authorities and clients. Maintain compliance with pharmacovigilance regulations (e.g., FDA, EMA, CDSCO). Collaborate with cross-functional teams to ensure accurate and complete safety data. Contribute to audit and inspection readiness. Prepare periodic safety update reports (PSURs) and other regulatory documents when required. Qualifications : Bachelors or Masters degree in Pharmacy, Life Sciences, or related field. Minimum 2 years of hands-on experience in PV ICSR processing. Strong understanding of global PV regulations and ICH-GCP guidelines. Familiarity with PV databases (e.g., Argus, ArisG) is an advantage. Excellent attention to detail and strong analytical skills. Good communication and documentation skills. Preferred Attributes : Certification in Pharmacovigilance will be an added advantage. Ability to work independently and as part of a team. Willingness to work in shifts if required (based on client/region).

As a Safety Associate, you will be responsible for reviewing, assessing, and processing safety data and information across service lines. Your key duties will involve distributing reports/data to internal and external parties, ensuring compliance with applicable regulations, SOPs, and internal guidelines, and working under the guidance of senior operations team members. You will need to prioritize and complete assigned trainings on time and process safety data according to regulations, guidelines, SOPs, and project requirements. Your role will also include performing pharmacovigilance activities such as collecting and tracking incoming Adverse Events (AEs)/endpoint information, determining the status of events, database entry and AE/product coding, writing narratives, and literature-related activities. To excel in this position, you must meet quality, productivity, and delivery standards while ensuring compliance with all project-related processes and activities. Additionally, you will be required to create, maintain, and track cases as per the project plan, identify and escalate quality issues to senior team members, and demonstrate problem-solving capabilities. As part of your responsibilities, you may mentor new team members if assigned, attend project meetings, and provide feedback to the operations manager. It is essential to maintain 100% compliance with people practices and processes and perform any other duties as assigned. Your technical skills should include good knowledge of medical terminology, a working knowledge of safety databases, basic knowledge of regulatory requirements, excellent attention to detail and accuracy, as well as good working knowledge of Microsoft Office and web applications. Strong organizational and time management skills, effective communication skills, self-motivation, flexibility, independence, and initiative are also required. You should also possess multitasking and prioritization abilities, delegation skills, learning agility, teamwork and collaboration skills, and a commitment to quality assurance. Moreover, your role will involve demonstrating IQVIA Core Values in daily tasks, utilizing communication tools extensively, and adapting to work conditions such as regular sitting for extended periods, occasional travel, and flexibility to work in shifts. For this position, a B.Pharm / M.Pharm / Pharm.D degree or a High School Diploma or equivalent in a scientific or healthcare discipline is required. Alternatively, a Bachelor's Degree in a relevant field with 1-1.5 years of experience is also necessary to meet the educational qualifications for this role.,

{"company":" Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through , a full-service oncology CRO, and multi-therapeutic global functional and CRO services through . The companys customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit . ","role":" Job Description The Senior Clinical Data Coordinator (Sr. CDC) is a key member of the Development Operations, Data Management Team. The Senior Clinical Data Coordinator will provide data management support for all assigned studies. The Sr. CDC prepares, validates, processes, and maintains clinical data in support of submissions to international regulatory agencies or publication of manuscripts through the use of EDC and SAS software. Assist in the development of edit specifications, based on any available global medical standards, therapeutic area standards, and the protocol, used to clean the study. Performs user acceptance testing (UAT) on eCRF build and edit specifications. Creates supporting DM process documentation to LDM and/or performs peer review of documentation, including updating documentation. Support the coding schedule defined in the data management plan. Collaborate with data coding specialists on a regular basis to guarantee timely coding. Supports/maintains quarterly coding review cycles. Performs manual data listing reviews and submits queries as appropriate. Assist with and/or performs user acceptance testing of lab data standards. Evaluates quality of lab data entry and addresses inconsistencies with sites and CRAs as applicable. Assists in the SAE reconciliation process. This may include coordination with medical experts and Global Drug Safety. Follow up on discrepancies and resolve so both databases are consistent. Applies criteria for subject stage gate of No More Issues (NMI). Also, must coordinate and review medical and statistical queries and certify they are adequately resolved. Assist in the development of a blind review report and conducting a blind review meeting to assign patient validity. Assist in developing and generating study report listings according to ICH and if present company guidelines. Coordinate the query management system functions. Perform the final patient review and database lock activities. Assist in coordinating the processing of scheduled data transfers (PK/PD data, imaging data, Laboratory data) from external vendors and performs relevant review/reconciliation. Review query responses and ensure data quality. Reviews Site responses to queries and evaluates the necessity of a re-query. If applicable, communications with Site Coordinators are performed for resolution. Attends and may lead internal and external team meetings. Reviews and/or provides meeting minutes. Supports training and development of Clinical Data Coordinators. Assists with eCRF design. May be required to develop the eCRF and/or provide peer review. May serve as a back up to the LDM for internal and external study teams. N/A Education : Bachelor s degree in related discipline and three years of related experience; or high school diploma and four years of related experience. Experience : See Education. Required Certifications : N/A Required Skills : Proficient with Microsoft Office Suite. Excellent written and oral communication skills. Excellent presentation skills. Strong organizational, problem-solving, and analytical skills. Ability to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities. Proven ability to handle multiple projects and meet deadlines. Strong interpersonal skills. Ability to deal effectively with a diversity of individuals at all organizational levels. Commitment to excellence and high standards. Creative, flexible, and innovative team player. Ability to work independently and as a member of various teams and committees. Good judgement with the ability to make timely and sound decisions. Ability to be discreet with sensitive company information. "},"

ProductLife Group is looking for Medical Reviewers, having 3-4 years of experience with MBBS/MD degree. Responsibilities: We are looking for a medical reviewer proficient in post-marketing drug safety. Post-Marketing (Pharmacovigilance) Medical review of the ICSRs (Spontaneous, literature, clinical studies) Support in seriousness assessment, Initial Triage Support in causality, medical assessment, benefit-risk evaluation of the medicinal product. perform additional review of cases to ensure competency. Participate in audits and inspections as required Ensure understanding of client needs, conventions and ensure expectations are met and exceeded Training and mentoring other team members on good assessment of the cases and MedDRA coding Required Education: MBBS, or MD (Doctor of Medicine) Required Experience: Client communications Safety Database experience Minimum 3-4 years experience working for service providers or pharmaceutical company in Pharmacovigilance department Additional experience and/or skills:: Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team. Clinical experience an advantage Ability to deliver constructive feedback Emotional intelligence Adaptability Analytical skills Flexibility Reliable Strong organisation skills Punctual Database experience

Clin Infotech is offering the internship opportunity for BDS MDS Dental Graduates Should have Knowledge in Pharmacovigilance Should Have knowledge on Argus & MEDDRA Applicants Should Complete Certification in Pharmacovigilance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage

Clin Infotech is offering internship Opportunities for B.Pharm and M.Pharm Freshers who are willing to start a career in Clinical Research Pharmacovigilance clinical data management sas Medical writing and Medical coding Required Candidate profile Clinical Research Internship includes of Hands on Experience on softwares in Clinical Research Pharmacovigilance clinical data management Domain. B.Pharm M.Pharm and Pharm D Are Eligible to Apply

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.

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