1738 Pharmacovigilance Jobs - Page 10

DARADIA PAIN HOSPITAL is looking for Pharmacist 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

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Screening scientific literature by using the internal search mechanism and/or by making use of external tools and providers. Classification of references of safety-relevant publications. To keep track of the internal literature ordering process. Data entry of literature reports into the safety database. Preparation of standard reporting forms (e.g., CIOMS I / MedWatch Forms and XML . Case completion / documentation. Downloading, reviewing and sharing of client specific ICSRs from MLM service of EMA. Performing duplicate search of literature cases against updated information in Medical Literature Monitoring (MLM) service provided by EMA. Act as main contact for client/project management. The employee agrees to take over primary listed tasks and responsibilities in other service lines and additional reasonable tasks that align with their abilities, qualification and training, if required. Screening scientific literature by using the internal search mechanism and/or by making use of external tools and providers. Classification of references of safety-relevant publications. To keep track of the internal literature ordering process. Data entry of literature reports into the safety database. Preparation of standard reporting forms (e.g., CIOMS I / MedWatch Forms and XML . Case completion / documentation. Downloading, reviewing and sharing of client specific ICSRs from MLM service of EMA. Performing duplicate search of literature cases against updated information in Medical Literature Monitoring (MLM) service provided by EMA. Act as main contact for client/project management. The employee agrees to take over primary listed tasks and responsibilities in other service lines and additional reasonable tasks that align with their abilities, qualification and training, if required. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Conduct Medical Review and assessment of ICSR s into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment. Review and respond to any queries/comments from the case owner in the patient safety database. Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers. Maintain strong GPVP and GCP knowledge. Following ICH and EMA guidelines strongly and implementing them appropriately. Train and mentor PV associates on event capturing and general PV conventions as required. Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas. Escalate complex case issues on client products to Team Lead/Line Manager. Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature. Provision of scientific input in the course of literature surveillance service. Maintain good knowledge of databases, regulations, guidelines and SOP s. To actively communicate and participate in internal project meetings. Participation in internal and external audits/inspections. Review and preparation of periodic safety reports (e.g., PSURs, PBRER) and RMPs. Collaborate with Global Pharmacovigilance team with respect to Signal Detection and its processes. Perform any other drug safety related activities as assigned. . Degree in Medicine. PG degree in any discipline is an advantage but not mandatory. Minimum 3 years of relevant experience in Pharmacovigilance & Drug Safety. Strong interpersonal and organizational skills to be a good team player. High sense of responsibility, dedication, and desire to work under pressure as required. Highly service oriented. Previous exposure to corporate environment, pharma and life sciences industry is an advantage. Good communication skills. Fluent in English- spoken and written. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Conduct Medical Review and assessment of ICSR s into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment. Review and respond to any queries/comments from the case owner in the patient safety database. Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers. Maintain strong GPVP and GCP knowledge. Following ICH and EMA guidelines strongly and implementing them appropriately. Train and mentor PV associates on event capturing and general PV conventions as required. Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas. Escalate complex case issues on client products to Team Lead/Line Manager. Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature. Provision of scientific input in the course of literature surveillance service. Maintain good knowledge of databases, regulations, guidelines and SOP s. To actively communicate and participate in internal project meetings. Participation in internal and external audits/inspections. Review and preparation of periodic safety reports (e.g., PSURs, PBRER) and RMPs. Collaborate with Global Pharmacovigilance team with respect to Signal Detection and its processes. Perform any other drug safety related activities as assigned. . Degree in Medicine. PG degree in any discipline is an advantage but not mandatory. Minimum 8 years of relevant experience in Pharmacovigilance & Drug Safety. Strong interpersonal and organizational skills to be a good team player. High sense of responsibility, dedication, and desire to work under pressure as required. Highly service oriented. Previous exposure to corporate environment, pharma and life sciences industry is an advantage. Good communication skills. Fluent in English- spoken and written. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Gurgaon, Haryana, India Job Description: Required Qualification and Core Competencies for the role: 8-12 years of experience in regulatory affairs in medical device industry. Strong knowledge of Medical Device Rule 2017 Strong knowledge of Drugs and Cosmetics Act Knowledge in the international regulations of Medical Devices in US and EU Sound knowledge on Medical Device Quality Management System ISO 13485 Excellent proficiency with software tools Key responsibilities: Draft, review and submission of Regulatory filings (Re-registrations/ New Registrations/ Legal-Physical manufacturer transfer). Draft, review and submission of other Regulatory submissions (Query responses, Corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for India and IB market in accordance with applicable regulations and relevant guidelines. Draft cover letters for Regulatory communications/ submissions depending on level of regulatory knowledge/expertise Update and live maintenance of business plan in SharePoint for assigned franchises/ licenses. Assist in the preparation of technical presentations/ meetings with regulator Ensures compliance with regulatory agency regulations and interpretations. Gathers and assembles information, prepares documents for New Product Applications/Renewal Applications/Change Notifications/Response to Regulatory Agencies questions in accordance with regulations and relevant guidelines Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations (Lifecycle management) Coordination with internal stakeholders ensuring compliant lifecycle management of responsible products/ franchises. Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations Attend applicable training sessions as well as complete mandatory on-line e University trainings and submit training records to the supervisor / Admin assistant and work as per the applicable SOPs and guidelines. Maintenance of RA database for the responsible franchises in MDRIM tool. Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/other portals. Ensuring timely completion of assigned Quality issues/ Corrective Actions in ETS system. Creation and maintenance of Product Registrations request Form (PRRF) for any registration activities under responsible franchises/ licenses and Change Controls for any product discontinuation/ changes as per defined procedure. Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/ other portal. Ensure on time archival of regulatory submission documents. Supporting Pharmacovigilance and artwork activities for biological products (if applicable) Control of regulated/ non-regulated products/ codes in RA gateway tool. Support with on-time inputs for monthly regulatory report. Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware. Conducting Regulatory Standard Management monthly meeting and keeping a track on action items identified.

We are looking for a skilled E-commerce Operations Manager to join our team at CSTE International, with 3-8 years of experience in the IT Services & Consulting industry. Roles and Responsibility Manage and oversee e-commerce operations for smooth and efficient functioning. Develop and implement strategies to enhance customer satisfaction and loyalty. Collaborate with cross-functional teams to achieve business objectives. Analyze market trends and competitor activity to identify growth opportunities. Ensure compliance with regulatory requirements and industry standards. Lead and motivate a team to achieve operational excellence. Job Requirements Proven experience in e-commerce operations management or a related field. Strong understanding of IT Services & Consulting principles and practices. Excellent leadership and communication skills. Ability to analyze data and make informed decisions. Strong problem-solving and strategic thinking skills. Experience with e-commerce platforms and technologies.

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

Position Purpose The PSSR Aggregate Report Analyst creates documents pertaining to post-marketing safety data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. These documents include but are not limited to integrated analyses of safety data in support of aggregate reports (e.g., Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, Safety Update Reports, Canadian Annual Reports, etc.), responses to regulatory queries on safety topics, post-marketing safety assessments, and Risk Management Plans and relevant documents. Accurately translate understanding of regulatory requirements and corporate policies governing documents for regulatory submission into execution of timely and compliant analyses and presentations of safety data and benefit-risk assessment in documents. Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues. Provide oversight for internal or external (contractor) co-authors when required for a particular project or assignment (e.g., Canadian Annual Report). Primary Responsibility Communicate WWS’s position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed. Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations. Drive the document strategies and messages in a collaborative way with relevant project team subject matter experts. Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents. Deliver assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality. If overseeing the work of or leading a team of other authors (internal or external), be accountable for timely delivery of high-quality, fit-for-purpose documents to the project team. Produce documents in conjunction with external vendors. Review documents produced by vendors and help evaluate vendor performance. Understand relationships and dependencies between documents and analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and ACOs. Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents. Develop and sustain constructive relationships within other Pfizer lines including country organizations. If assigned by manager, serve as the WWS ‘point of contact’ for all document issues for a given product or set of products. Identify potential areas for process improvements and possible solutions and communicate these to line management or appropriate functional line. Education: Bachelor's Degree in life sciences and 3+ years’ relevant medical experience such as, patient care, clinical trial experience / investigator, academic medicine, specialty training or pharmaceutical industry experience, ideally in safety, regulatory or clinical areas Advanced degree preferred (MD, DVM, PharmD, or Master’s/PhD in relevant field) Experience and Attributes: Able to execute routine analyses and interpret routine safety analyses with guidance from team members (analytic skills) Has comprehensive understanding of regulatory guidance as it pertains to presentation and communication of benefit/risk and pharmacovigilance (regulatory knowledge) Is able to synthesize analyses of aggregate or individual patient data into clearly written text with minimal supervision. (writing skills) Has good understanding of medical concepts of the disease and the specific approach to treatment. Makes decisions that require choosing between multiple options to resolve moderately complex problems, some of which deviate from standard situations. (analytic skills, and maybe interpersonal skills as well) Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Medical

Position Purpose The PSSR Aggregate Report Analyst creates documents pertaining to post-marketing safety data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. These documents include but are not limited to integrated analyses of safety data in support of aggregate reports (e.g., Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, Safety Update Reports, Canadian Annual Reports, etc.), responses to regulatory queries on safety topics, post-marketing safety assessments, and Risk Management Plans and relevant documents. Accurately translate understanding of regulatory requirements and corporate policies governing documents for regulatory submission into execution of timely and compliant analyses and presentations of safety data and benefit-risk assessment in documents. Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues. Provide oversight for internal or external (contractor) co-authors when required for a particular project or assignment (e.g., Canadian Annual Report). Primary Responsibilities Communicate WWS’s position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed. Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations. Drive the document strategies and messages in a collaborative way with relevant project team subject matter experts. Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents. Deliver assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality. If overseeing the work of or leading a team of other authors (internal or external), be accountable for timely delivery of high-quality, fit-for-purpose documents to the project team. Produce documents in conjunction with external vendors. Review documents produced by vendors and help evaluate vendor performance. Understand relationships and dependencies between documents and analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and ACOs. Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents. Develop and sustain constructive relationships within other Pfizer lines including country organizations. Identify potential areas for process improvements and possible solutions and communicate these to line management or appropriate functional line. Education Bachelor's Degree in life sciences and 2+ years’ relevant medical experience such as, patient care, clinical trial experience / investigator, academic medicine, specialty training or pharmaceutical industry experience, ideally in safety, regulatory or clinical areas Advanced degree preferred (MD, DVM, PharmD, or Master’s/PhD in relevant field) Experience And Attributes Able to execute routine analyses and interpret routine safety analyses with guidance from team members (analytic skills) Understands regulatory guidance as it pertains to presentation and communication of benefit/risk and pharmacovigilance (regulatory knowledge) Is able to synthesize analyses of aggregate or individual patient data into clearly written text under general supervision. (writing skills) Has basic understanding of medical concepts of the disease and the specific approach to treatment. Makes decisions that require choosing between multiple options to resolve moderately complex problems in standard situations. (analytic skills, and maybe interpersonal skills as well) Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Medical

Leadership & Strategy Provide leadership and direction for all pharmacy services and staff. Develop and implement departmental goals aligned with organizational strategy. Promote a culture of safety, excellence, and continuous improvement. Clinical Governance & Compliance Ensure adherence to national and institutional regulations (e.g., FDA, MHRA, GPhC, NABH). Oversee medication safety, formulary management, and pharmacovigilance programs. Lead audits, quality assurance initiatives, and risk mitigation strategies. Operational Management Oversee procurement, inventory, and distribution of medications. Optimize pharmacy workflows, staffing, and use of technology. Ensure availability of essential drugs and rational drug use. Financial & Resource Management Develop and manage department budgets. Monitor drug expenditure and implement cost-control measures. Lead contract negotiations with suppliers and vendors. Education & Research (if in an academic or teaching hospital setting) Supervise and mentor pharmacy staff, students, and residents. Oversee continuing education and professional development programs. Facilitate academic teaching, curriculum development, and research initiatives. Collaboration & Communication Liaise with clinicians, nursing, and administrative departments to ensure integrated care. Serve as the departments representative in institutional committees and external bodies. Engage patients and stakeholders in medication-related education and decisions.

Job Description: ❖ Prepare and maintain the Signal Schedule as per Standard Operating Procedures. ❖ Identification, Analysis, and Evaluation of safety signals arising from various data sources to determine signals or risks that could result in changes to labels and / or benefit-risk profile of the product. ❖ Evaluate the safety information and prepare product specific ADR (Adverse Drug Reaction) Sheet. ❖ Author Drug Safety Report (DSR) for Valid signals as per Standard Operating Procedures. ❖ Communicate findings from routine and ad hoc signal detection and assessment activities to concerned stakeholders. ❖ Contribute to cross-functional initiatives aimed at improving pharmacovigilance capabilities related to signal detection. ❖ Maintain awareness on new or revised regulatory requirements and guidelines relevant to Signal Management. ❖ Ensure regulatory compliance (quality, procedures, regulations, timeliness, consistency) for Signal Management process. ❖ Assist in preparation/revision of SOP, Work instructions, templates and guidance training documents concerning Signal Management. ❖ Impart trainings related to Signal Management activities, as and when required Skills Required: Regulatory Medical Writing | Intermediate Medical Literature Review & Analysis | Intermediate Adverse Event Reporting & Signal Detection | Advanced Regulatory Affairs Collaboration | Intermediate Safety Data Analysis & Visualization | Advanced Qualification - B. Pharm Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Preparation of responses to PRAC assessment reports and other Authority requests (e.g., referrals, etc). Performing signal detection and signal analysis of safety data, provide the appropriate expert advice as well as assisting in communication with regulatory agencies when the new data has an effect on the risk-benefit balance. SOP services/writing and review of SOPs, WIs and related documents and training material in the area of pharmacovigilance for clients (including implementation and training. Development of customer-specific solutions and processes in cooperation with clients. Build, develop and maintain working relationships with clients. Ensure client satisfaction and compliance with legal and regulatory requirements. Representation of the company and the team with clients, authorities and professional institutions. Inform the Head of the Pharmacovigilance Team/Service Line Lead regularly about systematic problems that could jeopardize an appropriate coordination of tasks and to present solutions. Management of parts of a project or the complete project. Fulfilling highly complex, sophisticated tasks within the area of pharmacovigilance. Trigger a non-conformity when any performance deviation from the target KPI (Key Performance Indicator) is detected, issue evaluation and root cause analysis, assign corrective actions with a due date to the most appropriate employee, ensure that all agreed actions are completed by the due date. Communicate proactively with clients about the status of the project and provide solutions to address process deviations, quality issues and inefficiencies. Development of processes and/or tools within the area of pharmacovigilance in collaboration with the Head of the team and the Head of the Pharmacovigilance Department. Design and prepare Standard Operational Procedures, Working instructions and Client Specifications for Pharmacovigilance processes, ongoing revisions and implementation of updates. Contribute to achievement of departmental goals, Identify and discuss out-of-scope activities that affect project invoicing. Client audits (preparation of the audit, defend it, review the audit report and follow action plan). Contribute to resource needs and resource allocation to ensure compliance, identification and implementation of process efficiency needs. . Minimum 4 years of experience in relevant field. Experience in writing and reviewing PBRER, PSUR, RMP, PADER and ACO Experience in Preparation of responses to PRAC, other authority requests Experience in writing and review SOP, preparing training material Build update and maintain working relationships with client What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Conduct Medical Review and assessment of ICSR’s into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment. Review and respond to any queries/comments from the case owner in the patient safety database. Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers. Maintain strong GPVP and GCP knowledge. Following ICH and EMA guidelines strongly and implementing them appropriately. Train and mentor PV associates on event capturing and general PV conventions as required. Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas. Escalate complex case issues on client products to Team Lead/Line Manager. Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature. Provision of scientific input in the course of literature surveillance service. Maintain good knowledge of databases, regulations, guidelines and SOP’s. To actively communicate and participate in internal project meetings. Participation in internal and external audits/inspections. Review and preparation of periodic safety reports (e.g., PSURs, PBRER) and RMPs. Collaborate with Global Pharmacovigilance team with respect to Signal Detection and its processes. Perform any other drug safety related activities as assigned. . Degree in Medicine. PG degree in any discipline is an advantage but not mandatory. Minimum 3 years of relevant experience in Pharmacovigilance & Drug Safety. Strong interpersonal and organizational skills to be a good team player. High sense of responsibility, dedication, and desire to work under pressure as required. Highly service oriented. Previous exposure to corporate environment, pharma and life sciences industry is an advantage. Good communication skills. Fluent in English- spoken and written. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Conduct Medical Review and assessment of ICSR’s into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment. Review and respond to any queries/comments from the case owner in the patient safety database. Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers. Maintain strong GPVP and GCP knowledge. Following ICH and EMA guidelines strongly and implementing them appropriately. Train and mentor PV associates on event capturing and general PV conventions as required. Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas. Escalate complex case issues on client products to Team Lead/Line Manager. Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature. Provision of scientific input in the course of literature surveillance service. Maintain good knowledge of databases, regulations, guidelines and SOP’s. To actively communicate and participate in internal project meetings. Participation in internal and external audits/inspections. Review and preparation of periodic safety reports (e.g., PSURs, PBRER) and RMPs. Collaborate with Global Pharmacovigilance team with respect to Signal Detection and its processes. Perform any other drug safety related activities as assigned. . Degree in Medicine. PG degree in any discipline is an advantage but not mandatory. Minimum 8 years of relevant experience in Pharmacovigilance & Drug Safety. Strong interpersonal and organizational skills to be a good team player. High sense of responsibility, dedication, and desire to work under pressure as required. Highly service oriented. Previous exposure to corporate environment, pharma and life sciences industry is an advantage. Good communication skills. Fluent in English- spoken and written. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Should have knowledge in Clinical Data Management Should have good knowledge in edit checks crf design SAE Reconcilation crf annotation Clinical Data Management Trained Candidates Only Eligible Required Candidate profile Strong understanding of clinical data management and E2b Guidelines Excellent clinical assessment and Communication Skills

Job Description JOB DESCRIPTION ❖ Prepare and maintain the Signal Schedule as per Standard Operating Procedures. ❖ Identification, Analysis, and Evaluation of safety signals arising from various data sources to determine signals or risks that could result in changes to labels and / or benefit-risk profile of the product. ❖ Evaluate the safety information and prepare product specific ADR (Adverse Drug Reaction) Sheet. ❖ Author Drug Safety Report (DSR) for Valid signals as per Standard Operating Procedures. ❖ Communicate findings from routine and ad hoc signal detection and assessment activities to concerned stakeholders. ❖ Contribute to cross-functional initiatives aimed at improving pharmacovigilance capabilities related to signal detection. ❖ Maintain awareness on new or revised regulatory requirements and guidelines relevant to Signal Management. ❖ Ensure regulatory compliance (quality, procedures, regulations, timeliness, consistency) for Signal Management process. ❖ Assist in preparation/revision of SOP, Work instructions, templates and guidance training documents concerning Signal Management. ❖ Impart trainings related to Signal Management activities, as and when required Skills Required Regulatory Medical Writing | Intermediate Medical Literature Review & Analysis | Intermediate Adverse Event Reporting & Signal Detection | Advanced Regulatory Affairs Collaboration | Intermediate Safety Data Analysis & Visualization | Advanced Qualifications Qualification - B. Pharm About Us Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion. About The Team The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs. Key Roles That The Human Resources Team Performs Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions. Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures. Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing. Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance. Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.

Job title : Pharmacovigilance Case MR Oversight Specialist Location: Hyderabad Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally . Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. Need MBBS with 2-3 years of experience in ICSR Medical Review Activities***** Main Responsibilities The primary function of the Case Medical Review (MR) Oversight specialist is to perform the medical and regulatory evaluation of all ICSRs. Oversee the Medical Review of ICSRs as per predefined activity and job-role in PV safety database (DB), with special focus on case medical accuracy and documentation. Maintain overall accountability for the timeliness and quality of medical Case Management activities outsourced to service providers. Be the product medical expert from Medical Review Standpoint for all High priority Products and provide training & guidance to MR teams Lead or participate in cross-functional projects or initiatives within global PV collaborates with the Global Safety Officer (GSO) in the review of clinical trial and post-marketing program documentation and on labeling activities. Establish strong collaboration with cross-functional groups within and outside the company (i.e. Business Partners, CRO). Provide or receive training on Customer-specific processes, systems, or products. Perform daily quality review for ICSRs to allow analysis of data entry/ quality. Reconcile SAEs between the Clinical and Safety DBs to meet joint accountabilities and enable locking of Clinical DB. Provide support for the preparation of response to ad hoc HA queries, provide input into responses to inquiries from health care professionals on safety issues. Assist in study configurations of clinicals trials in the safety database Responsible for performing oversight of non-serious line listing as applicable. Creates and maintains relevant SOPs, job aids for medical review activity. Other PV tasks as required Experience About you Experience in PV Databases like ARGUS, Aris-G (LSMV) VAULT Safety, etc. Strong Experience in medical review of ICSRs Experience in labelling and causality assessments is must. Experience in overseeing vendors responsible for case processing. Experience with SDEA agreements Experience review in signal activities, RMP, PBRERS, and PADERS etc. Strong experience review of non-serious line listings. Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation Good knowledge of MS Office Strong experience in ICSR quality review and submissions Incumbent should have experience in Process Improvement practices Soft Skills Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Excellent team-work and interpersonal skills Ability to work in cross-functional teams Excellent oral and written communication skills Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Technical Skills Regulatory Standards: In-depth knowledge of global pharmacovigilance regulations and guidelines, such as those from the FDA, EMA, ICH, and other health authorities. Knowledge of how adverse events are reported and classified (e.g., by severity, outcome) and the regulatory requirements surrounding these reports Safety Reporting Requirements: Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS, etc.) and experience in ensuring compliance with these standards. Good Pharmacovigilance Practices (GxP): Familiarity with GxP guidelines, ensuring that all pharmacovigilance processes adhere to industry standards. Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data. Microsoft Office Suite: Advanced skills in Excel (for data analysis and reporting), Word (for report writing), and PowerPoint (for presenting findings) Education MD degree / or MBBS/Pharm D equivalent Academic qualification is desirable. Languages : Fluent in English (verbal and written) Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers: We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things: All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers

Main Responsibilities The is a centralized role that is Responsible for collaborating with Country Safety heads (CSHs), Qualified Person for Pharmacovigilance (QPPV) office, SDEA, PV Case Medical Safety Manager, SSDM team to ensure that appropriate reporting rules (product, study, country) have been configured in the global PV DB. Responsible for overseeing PV labelling documents in Veeva Vault and ensure access to all parties involved. Responsible for providing support on getting labelling automated within PV Safety DB for all CHC products. Responsible for coordinating between countries and SSDM team for configuring distribution/ reporting rules. Responsible to follow QDs/ SOPs relevant to above mentioned activities. Responsible for review of the Weekly Veeva Flash report for newly registered CHC Products and configuration in the global PV database. Responsible for review of the Weekly Veeva Monitoring listing received for registration lifecycle updates for products globally and requesting the updates in global PV database CPD. Responsible for review of Vault RIM product updates and addition of new products for configuration in global PV database CPD. Responsible for maintaining mapping sheets of CHC products and truncated product lists with their respective names Responsible for review of the Regulatory Intelligence updates emails (CHC Global PV contact mailbox) from CSH/Affiliates, release communication to respective stakeholders and track the progress the required updates in global PV database as applicable. Responsible for implementation Annual product review and Annual distribution rules review with the help of CSH for all the countries and CHC products in global PV database as per the established SOPs. Other PV tasks as required. This role is responsible for ensuring product configurations, distribution rules configurations and maintain of CPD. This position requires multiple interfaces with partners and customers within and outside of the Company This role involves understanding the constantly changing PV Regulations and ensuring that we follow them Experience About you Experience in PV Databases like ARGUS, Aris-G (LSMV) VAULT Safety, etc. 3-4 years of pharmaceutical industry experience with a focus on pharmacovigilance Experience in case processing activities. Experience in product configurations, reporting rule configurations. Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation Good knowledge of MS Office Good knowledge SDEA agreements Strong experience in product dictionaries and database reporting rule configurations Incumbent should have experience in Process Improvement practices Soft Skills Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Excellent team-work and interpersonal skills Ability to work in cross-functional teams Excellent oral and written communication skills Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Technical Skills Regulatory Standards: In-depth knowledge of global pharmacovigilance regulations and guidelines, such as those from the FDA, EMA, ICH, and other health authorities. Knowledge of how adverse events are reported and classified (e.g., by severity, outcome) and the regulatory requirements surrounding these reports Safety Reporting Requirements: Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS, etc.) and experience in ensuring compliance with these standards. Good Pharmacovigilance Practices (GxP): Familiarity with GxP guidelines, ensuring that all pharmacovigilance processes adhere to industry standards. Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data. Microsoft Office Suite: Advanced skills in Excel (for data analysis and reporting), Word (for report writing), and PowerPoint (for presenting findings). Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way Education Bachelor’s degree in pharmacy / Life Sciences / or equivalent Academic qualification is desirable with 3-4 years’ experience in Global PV database and/or PV case Management Languages : Fluent in English (verbal and written)

As a Senior Executive/ Assistant Manager in the Corporate Quality Assurance Pharmacovigilance department, located in Kandivali - West, Mumbai, your primary responsibility will be to ensure compliance with SOPs of the Corporate Pharmacovigilance cell and Corporate Quality Assurance. You will be expected to assist the Corporate pharmacovigilance cell in overseeing vendor compliance through periodic reviews and vendor audits. In this role, you will act as a liaison with internal and external auditors, taking responsibility for ensuring corrective actions are implemented according to their specifications. Your duties will also include persuading Corporate pharmacovigilance cell staff to adopt and incorporate quality methods into their work processes. As part of your responsibilities, you will be required to conduct internal pharmacovigilance audits, perform CAPA management, and review the change control process, deviations, and related Quality Management System (QMS) documents. Additionally, the role involves travel for conducting audits at corporate offices and various plants. The ideal candidate for this position should hold an M Pharm qualification and possess 4 to 6 years of relevant experience in the field. Effective communication skills, attention to detail, and the ability to work collaboratively with internal and external stakeholders are crucial for success in this role.,

Senior Drug Safety Associate Category: Reg Affairs & Safety Pharmacovigilance Location: Bangalore, Karnataka, IN Novo Nordisk Global Business Services Senior Drug Safety Associate Are you driven by challenges and energized by a fast-paced, dynamic environment? Do you thrive in a role where strategic alignment, stakeholder collaboration, and continuous improvement are key to success? We are looking for a Senior Drug Safety Associate to join our growing team in an international setting. In this pivotal role, you will work closely with cross-functional teams to ensure the highest standards of patient safety and regulatory compliance throughout the drug development lifecycle. Apply now and become part of a collaborative, forward-thinking environment where your expertise truly makes an impact. About The Department: Global Patient Safety Bangalore (GPS-BLR) was set up in 2010 as one of the hubs for safety case processing. We handle case processing and medical review of Individual Case Safety Reports from different sources (spontaneous, literature, solicited and clinical trials). We are additionally engaged in safety surveillance, safety medical writing, safety report submission, training, quality control of ICSRs, Argus configuration and maintenance, information technology quality assurance, training co-ordination and literature surveillance activities, including medical literature monitoring. The Position : As a Senior Drug Safety Associate you will be responsible for the comprehensive management of both serious and non-serious adverse event reports from various sources. Your core duties will include initial medical evaluation, accurate case entry, and verification of safety data within the Novo Nordisk safety database (Argus). You will ensure consistent and precise coding using MedDRA, evaluate causality, seriousness, and listedness, and ensure that case narratives reflect accurate and relevant safety information. You will also assess the need for follow-up, issue appropriate queries in the EDC system and/or to affiliates, and actively participate in weekly literature surveillance activities. Responsible to conduct medical evaluation, coding, and case processing of serious and non-serious adverse events in compliance with GxP and regulatory requirements, using Argus and MedDRA. Liaise with global affiliates, partners, and internal stakeholders to clarify safety data, ensure timely follow-up, manage local literature, and support compliance activities. Collaborate with Safety Reporting and IT teams for data retrieval, custom reporting, and to assess system/process changes impacting pharmacovigilance operations. Ensure Support system optimization and data integrity, collaborating with Safety Reporting and IT for custom data retrieval, reporting, and assessing the impact of system or process changes on pharmacovigilance activities. Mentor and train colleagues, act as a buddy, and proactively contribute to continuous process improvement across global safety functions. Qualifications: We are looking for a candidate who can bring the following skills and experience to the role: Graduation and/or post-graduation in Life Sciences (e.g., Medicine, Pharmacy, Biotechnology, Nursing). Minimum experience of 4 years in processing of Individual case safety reports (ICSR). Experience in mentoring, training, quality trend analysis will be preferred. Sound knowledge and hands-on experience in Pharmacovigilance and adverse event reporting processes which includes triage/intake, data entry, Quality review within various case types. Knowledge of safety databases like Argus and familiarity with MedDRA coding. Strong understanding of medical terminology, clinical pharmacology, and global PV regulatory requirements. Familiarity with GxP as well as GDPR standards and compliance expectations within a pharmaceutical setting. Proficient in MS Windows applications, including Excel, Word, Outlook, and PowerPoint. Excellent written and verbal communication skills in English, with a strong ability to convey medical and scientific concepts clearly. Proven ability to work within cross-functional teams and collaborate across global departments and affiliates. Demonstrated ability to foresee and assess the impact of system/process changes on safety operations. Solid understanding of Novo Nordisk products, including mechanisms of action, safety profiles, and patient populations. Experience working in a pharmaceutical company or a similar organization. Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing. Contact To submit your application, please upload your CV online (click on Apply and follow the instructions). Deadline 29th July 2025. Disclaimer It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.

Kenvue is currently recruiting for a: Sr. Technology Product Analyst, Medical Safety What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Who We Are Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. Role reports to: Sr R and D Med Safety Tech Product MGR Location: Asia Pacific, India, Karnataka, Bangalore Work Location: Hybrid What you will do Sr. Technology Product Analyst, R&D Medical Safety This position reports into the Senior Technology Product Manager, R&D Medical Safety and is based at Bangalore, India What You Will Do As the Sr. Technology Product Analyst, R&D Medical Safety, you will play an exciting role in identifying, shaping and delivering new solutions to lead transformational change and accelerate business value. Our solutions include the development of custom software solutions that lead to groundbreaking change and accelerate business value. You and your team will collaborate with key technology and business partners to apply human-centered design techniques to empathize with users, execute experiments, and help design solutions that delight them! We know custom is not always the answer – delighting R&D partners may also require maximizing off the shelf and SAAS solutions. You will partner with R&D Product Owners, Architects, Engineers, and Designers to ensure high quality development of critical technical product artifacts - e.g. vision, roadmap, backlog, user-stories and solution blueprints. You will then engage skilled resources to develop and incubate the solution Minimum Viable Product and, when successful, continue to scale, launch and continually develop that solution to drive higher levels of community engagement and participation. For existing solutions, the Sr. Technology Product Analyst, R&D Medical Safety will work with R&D Product and System Owners to continually evaluate and co-create product roadmaps. You will partner with other technical teams internally and externally, ensuring the integration and alignment of key product roadmap capabilities, while also addressing critical technical lifecycle management and key compliance activities. You will employ Agile best-practices to accelerate speed and deliver solutions to our patients and professionals. We need your help to unlock the power of data - to define insights across R&D that drive action. We seek leaders with a B.S. or equivalent with a minimum of 4 years of related technology experience. We expect experience in analysis, strategic assessment, product/project management, and GxP compliance activities. We support unique and independent thought and creativity, combined with pragmatic analytical rigor - with the ability to cultivate significant insights that inspire and inform our technical solutions. If you are looking for a dynamic and creative technology role helping people live more healthy and vibrant lives as part of Johnson & Johnson Consumer Health, this may be the career opportunity to help make it happen! Are you ready to join us? Key Responsibilities We are a customer centric and integrated team. You will develop a keen understanding of R&D needs and perceptions. You will partner closely with business technology leaders and internal and external technology partners to build and support innovative product solutions for Medical Safety groups on a world-wide basis. You will apply this knowledge to improve key business outcomes through driving the execution and delivery of work. We love data. You will seek opportunities to drive continual improvement, utilizing both new and existing metrics. You will partner with R&D to implement the actionable insights that you identified, based on your deep understanding of how our partners work. We also work in a GxP compliant environment. You will ensure that J&J information assets are appropriately identified, valued, and protected by aligning with and enforcing all local and worldwide security policies. We love creativity. You are hungry to understand and exceed in meeting the needs of the business. You will look to combine existing technologies in creative ways to solve business problems. We believe low code or no code solutions can be the answer and are critical assets to test and learn if our solutions are on track to delight users. We love learning about technology and have the aptitude to do so. You will seek to understand where and how key technical solutions such as APIs, microservices, and intelligent automation to best meet the needs of our business partners. We are a global team. You will partner with an extended team of both internal and external partners across multiple time-zones to provide technology solutions that delight. You will regularly provide customer-facing communications and demos related to your products, their budgets, and their value delivery to senior leaders from Technology and R&D organizations. What We Are Looking For Required Qualifications Minimum of a Bachelor’s degree in computer science, engineering, or related is required. A minimum of 4 years of related business experience is required. Excellent written and oral communication skills, interpersonal skills, strong negotiating skills, and the ability to motivate in a collaborative environment with exceptional service orientation. The ability to synthesize leadership and partner inputs into decisions, to independently lead, shape and deliver projects of medium to high level of complexity, and to thrive operating among senior R&D partners. Ability to estimate required effort for project objectives and prioritize work items appropriately, backlogs prioritization. Ability to craft context around key business features and behaviors and present ideas in business-friendly and user-friendly language. Strong IT background with a consistent record of delivering results. Proven leadership, influencing skills, interdependent partnering skills, as well as critical thinking skills is required. Experience working in an Agile team leveraging SDLC methodology, Risk management including Security. Power-BI, Sql queries, Cloud based, Database structuers and understandings, Different types of integration and APIs, Oracle Argus. Desired Qualifications Experience working with R&D, Medical Safety, Pharmacovigilance, and/or Complaint Management. Working knowledge of the FDA and its processes. Hands on understanding of Design Principles (User Interface and Business Process) is preferred. Working knowledge of Atlassian tools such as AgileCraft, Jira, Confluence, BitBucket, Bamboo, Trello is preferred. Hands-on focused product/project management and exceptional organization skills are preferred. If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

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

Roles and Responsibilities Perform medical review of Individual Case Safety Reports (ICSRs) , Serious Adverse Events (SAEs), and SUSARs Conduct causality and seriousness assessments of adverse events Validate case narratives and ensure medical accuracy and regulatory compliance Participate in safety signal detection and risk evaluation Contribute to the preparation and review of aggregate reports : PSUR, PBRER, DSUR, RMP Support updates to product safety labels (SmPC, PI) based on current safety data Collaborate with regulatory, clinical, and medical affairs teams for cross-functional safety activities Provide clinical input on global pharmacovigilance strategies and safety documents Respond to regulatory authority inquiries regarding safety issues Qualifications MBBS / MD (Pharmacology, Internal Medicine, or equivalent) Mandatory Minimum 2-5 years of experience in pharmacovigilance or clinical safety Prior experience in medical review of PV cases and signal management preferred Familiarity with ICH-GCP , MedDRA , WHO-ART , and global regulatory guidelines Experience with Argus / ARISg or other PV databases is a plus Excellent written and verbal communication skills Interested to apply can share CV or call/WhatsApp to 9342735755

Site Name: India - Maharashtra - Worli Mumbai Posted Date: Jul 21 2025 Job Purpose LOC Complaint Handler. Handling of Counterfeit/Suspected Counterfeit incidents. Toll free service coordinator Deviation Coordinator CAPA Coordinator Key Responsibilities LOC COMPLAINT HANDLER Route the customer communication Handle communication received from Tech Mahindra as per SOP for Handling calls received on Toll free number for Pharma and Vaccines Log the complaint in a validated system (as applicable) and assess criticality. Follow-up with customer and request sample unless justified that the sample is not required. Route complaint and any sample to the investigating site based on the defect observed. Assess/review if complaint is associated with HSI/AE and if it is, inform the local Pharmacovigilance (PV) representative within 24hrs. Maintain any Safety data cross-references and forward any follow-up information to the local/Global PV representative. Ensures that any HSI data cross-reference is maintained Reviews the complaint data for any other similar complaints from the role of product complaint handler. Forward complaints which are not related to product quality to concerned stakeholders (e.g.: Complaints on market shortages to distribution department, AE & SAE related to PV/Medical) Perform local trending of complaints and escalate adverse trends to Safety and/or Quality functions. Perform monthly reconciliation of HSI with the PV/safety (Global Service Provider). Escalate actions which may be overdue or at risk of non-compliance to LOC quality council. Carry out an annual review of the process so that it continues to be effective and to identify improvement. To share complaint tracker and reconciliation with global service provider. COUNTERFEIT HANDLER: To log the complaint for received suspected counterfeit product and record the information received. To forward the suspected counterfeit sample and received information/ documents to the manufacturing site for investigation Coordinate with LOC regulatory if any discussion with local regulators is required. Call for LIC/PIRC if the site confirms of confirmed counterfeit Coordinate with Legal Brand Protection (LBP) to report the suspected counterfeit. To escalate to Quality council as appropriate To generate AFPR report in case of confirmed counterfeit. TOLL FREE SERVICE COORDINATOR: To ensure SOP in place and in use. To ensure Toll free third party employee are trained on applicable trainings. Ensure Monthly KPI reporting by third party as per SOP. To provide the updates to quality council. To support third party if they have a confusion or doubt in the communication received. To provide standard response in case of repeat product queries, as applicable. To perform monthly reconciliation of Toll-free communications received as per SOP. DEVIATION CO-ORDINATOR: Ensure deviation are raised for nonconformance from the applicable procedures. Track and monitor all the deviations of LOC function for timely closure. Escalate critical incident / deviations at Quality Council or LOC governance forums. Monitor periodic trend reviews of deviations, including assessment of effectiveness of action taken. Escalate actions which may be overdue or at risk of non-compliance to LOC Quality Council. Report deviation KPIs to relevant governance forums and for monthly reporting as required CAPA CO-ORDINATOR: Implement global process to effectively manage corrective and preventative action plans. Develop local processes to conduct root cause analysis to investigate deviations and develop CAPA’s. Implement a local process to track and review CAPA plans on routine basis. Manage CAPA’s for the entire LOC and ensure that CAPA’s arising out of a non- compliance is logged into VQMS. Demonstrate that LOC effectively identifies where CAPA plans are required and that they are effectively implemented, monitored and closed out. Escalate actions which may be overdue or at risk of non-compliance to LOC Quality Council. Ensure KPIs are introduced that provide assurance that the process is effective and drives improvement. Report CAPA KPIs to relevant governance forums and for monthly reporting as required. OTHER: To perform the QMS gap assessment for the relevant system, where required. Preparation, revision of LSOPs as per requirement. To perform MM, Third party audits, Scoping visit of third party after appropriate qualification Identify and log risk and outline, monitor and implement appropriate mitigation plans. To collate and submit data for KPI management and other governance forum like QC, EMQC, RMCB etc. Complete mandatory trainings by the due date. Perform a job only after completion of training on that topic. Ensure that all internal procedures and systems which are in LOCQ are followed and complied with. Any additional responsibility assigned by the line manager as and when required. Knowledge/ Education / Experience Required Educational Background Minimum Level of Education - Graduate in Science / Pharmacy Area of Specialisation - Broad and through technical and regulatory knowledge of current pharmaceutical processes, QMS activities such as Complaint Management, Change control, deviations and CAPA management. Why is this Level of Education Required? - To support LOC Quality and to carry out all the responsibilities mentioned under the given job role Job-Related Experience Minimum Level of Job-Related Experience required Preferably 3 -10 years experience in Quality Assurance in Pharmaceutical industry. Having adequate knowledge of complaint management system and experience in handling of complaints as per quality assurance function. Why is this Level of Experience Required - To support LOC Quality and to carry out all the responsibilities mentioned under the given job role Other Job-Related Skills/Background Good knowledge of documentation / regulatory requirements and quality management system. Breath knowledge in quality systems principles and practical application. Good knowledge of quality management tools. Demonstrated sound decision-making process, based on the facts and data, and application of Risk management principles. Exposure and competencies with respect to multiple dosage forms. Excellent verbal and communication skills, collabrative team member and team leader. Demonstrated ability to effectively multi-task. Ability to excel in execution Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. 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Job Description This role is responsible for providing technical support to the concerned Sales teams across Bihar, Jharkhand, Assam and West Bengal, by conducting technical trainings related to animal health and products to field sales personnel , organizing and participating in the technical seminars to field veterinarians & customers along with Sales team, attending the customer complaints, meeting Veterinary professionals of field and colleges for sharing of technical inputs, coordinating with Veterinary Service Dept. Corporate and Diagnostic laboratory in disease surveillance, customer requirements and field trials Our Veterinary team use their scientific background to provide technical expertise and education to our customers, sales and marketing teams. With a deep knowledge of pharmacology and animal health we engage scientific exchange with external experts and industry leaders ensuring the scientific value of our animal health portfolio is understood. Responsibilities Primary responsibilities include: Providing Technical Services to customers in assigned geography (these services include on-site customer visits along with Sales Team & off-side telephonic support as well) and executing a comprehensive Tech service plan for maximizing Organizational goals. Customer Meetings: Meet customers in a group to create awareness about relevant scientific practices and advancements with the objective to become a partner of choice among customers. Technical Upgradation of the Sales team in assigned geography: Staying ahead of curve for recent technical development in Ruminant Industry and preparing internal competencies to provide customer support. Supervising Local Clinical Trials and Market support studies under the guidance of Sr. Tech Manager. Publication of Clinical Trials & Market Support Study Outcomes in relevant peer-reviewed Scientific Journals Supervise and provide timely and effective technical materials which maximize selling efforts. Collaboration with relevant Technical & Veterinary Education institutes in assigned geographies to further improve our image as Science Driven Organization Any other relevant task which can help in improving business. Rol Technical support to Pharmacovigilance team P.S: The Head quarter for this role can be either Patna or Kolkata and this profile requires extensive travelling Qualifications & Skills Degree in Veterinary Sciences 2-3 years of field experience to handle all field situations and provide technical solutions to customer needs. Freshers and Women candidates are also welcome for this opening. Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet. Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation: VISA Sponsorship Travel Requirements: Flexible Work Arrangements Not Applicable Shift Valid Driving License: Hazardous Material(s) Required Skills: Preferred Skills Job Posting End Date: 06/30/2025 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R301402