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3.0 - 5.0 years

4 - 8 Lacs

Bengaluru

Work from Office

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Analyst Qualifications: BCom Years of Experience: 3 to 5 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 Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Commitment to qualityAbility to work well in a teamAgility for quick learningAbility to manage multiple stakeholdersAbility to handle disputes Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification BCom

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0.0 - 1.0 years

3 - 7 Lacs

Bengaluru

Work from Office

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: BCom Years of Experience: 0 to 1 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 Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Commitment to qualityAdaptable and flexibleAbility to work well in a teamAgility for quick learningAbility to meet deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification BCom

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3.0 - 5.0 years

4 - 8 Lacs

Bengaluru

Work from Office

Skill required: KYC Screening - Sanctions Screening Designation: Regulatory Compliance Analyst Qualifications: BCom Years of Experience: 3 to 5 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 Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeAbility to effectively and efficiently conduct the process of screening individuals, entities, or transactions against lists of sanctioned or restricted parties. Sanctions screening involves using specialized software, understanding relevant regulations, and maintaining a proactive approach to mitigate the risk of engaging with sanctioned entities. What are we looking for Commitment to qualityCollaboration and interpersonal skillsAbility to work well in a teamAbility to perform under pressureAbility to meet deadlines Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification BCom

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6.0 - 10.0 years

8 - 12 Lacs

Bengaluru

Work from Office

We are looking for a skilled Accounting Specialist to join our team in the Merchandise Payables department. The ideal candidate will have 6-10 years of experience in accounting and finance, with expertise in managing merchandise payables and ensuring timely payments. Roles and Responsibility Manage and process merchandise payables transactions accurately and efficiently. Coordinate with cross-functional teams to resolve payment-related issues and discrepancies. Develop and implement effective accounting procedures to improve financial performance. Analyze financial data to identify trends and areas for improvement in merchandise payables. Ensure compliance with company policies and regulatory requirements. Maintain accurate and up-to-date records of merchandise payables transactions. Job Requirements Bachelor's degree in Accounting or Finance. Minimum 6 years of experience in accounting and finance, preferably in retailing. Strong knowledge of accounting principles and practices. Excellent analytical and problem-solving skills. Ability to work effectively in a fast-paced environment and meet deadlines. Strong communication and interpersonal skills. Experience working with J C Penney Services India Pvt Ltd is preferred.

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0.0 - 2.0 years

0 - 0 Lacs

pune

On-site

Assist in the collection, cleaning, and validation of clinical trial data from various sources. Perform data entry and data review activities to ensure quality and integrity. Support database setup, testing, and maintenance activities. Track and manage queries related to data inconsistencies and work with clinical sites to resolve them. Maintain documentation in compliance with Good Clinical Practice (GCP) and standard operating procedures (SOPs). Collaborate with cross-functional teams including clinical operations, biostatistics, and medical writing. Support the preparation of data management reports and metrics. Participate in team meetings, training sessions, and project discussions.

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6.0 - 7.0 years

8 - 12 Lacs

Bengaluru

Work from Office

Mgr, RA EU Generics Labeling Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Area of Interest Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Mgr, RA EU Generics Labeling Jul 21, 2025 Bangalore, India, 560064 Who we are The opportunity Ensure the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products. Provide internal pharmaceutical and medical expertise to address internal and authority-related inquiries and resolve labeling issues. Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling. How you ll spend your day Responsible for creating and updating compliant English product information for EU procedures. Strategic planning and implementation of changes affecting multiple product information documents. Determination of an implementation plan and tracking the implementation of updates due to new requirements (e. g. new excipients warnings, QRD template update). Providing instructions and guidance to local RA (e. g. calculations due to new excipients warnings). Discussion of the content of product information for innovative products (pre- and post-approval) in project teams. Evaluate and approve change requests; coordinate submissions with EU regulatory units. Collaborate on patent-related issues with Global IP Group. Contribute to readability studies and ensure PIL readability and compliance with legal requirements. Adaption to reference medicinal product (generic, hybrid, biosimilar procedures). Preparation of Expert statements (justification) for type II variations. Providing scope of variation to regulatory affairs. Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates. Monthly monitoring and communicating safety updates from EU authority websites. Track reference product updates and legal/guidance changes affecting product information. Assess need for updates based on Company Core Safety Information (CCSI). Implement PV triggered and non-PV triggered safety updates (e. g. PRAC/PSUSA/PSUFU, Referrals (Articles 31 + 107i), article 30 procedures, etc. ) in line with SOPs; collaborate on safety-related actions with Pharmacovigilance and QA. Participation in Product Safety Group (PSG) Meetings. Implementation of internal signals (including determining PIL wording). Scientific Work & Authority Communication Respond to authority deficiency letters in collaboration with other departments. Coordinate creation and approval of packaging mockups, Braille, and specimens. Address authority queries and ensure compliance with EU regulations. Assist with training new team members Your experience and qualifications Experience: 6 to 7 years in relevant fields (medicinal information and EU labeling in the pharmaceutical industry) ideally in Regulatory Affairs. Education: Completed at least 8-semester university degree in natural sciences (e. g. , Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry), preferably with a PhD. Other: Advanced English (spoken and written), strong MS Office skills, knowledge of European pharmaceutical law and regulatory affairs. Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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2.0 - 4.0 years

2 - 6 Lacs

Chennai

Work from Office

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 Bachelors 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) Medical #LI-PFE

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3.0 - 6.0 years

5 - 9 Lacs

Chennai

Work from Office

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: Bachelors 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) Medical #LI-PFE

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3.0 - 7.0 years

0 Lacs

Hyderābād

On-site

Job title: Sr. Specialist - Quality Services (Product Complaints) Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs. Main responsibilities: Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements. Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments. Evaluate complaints for severity and risk, ensuring timely review and processing. Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites. Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections. Participate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigations. Focus on operational tasks within the compliant handling process. Identify and implement continuous improvement opportunities. Provide regulatory interpretation and guidance to internal teams. Manage and oversee the training within the department. Perform quality checks on PQC activities, prepare reports, and maintain inspection readiness. Determine if the PTC is associated with an Adverse Event, Pharmacovigilance (PV) Special Situation. Ensure respective teams are communicated (As applicable). Ensure to complete all the required fields in tools and assign the complaint to respective investigation owning site. Ensure completion of the investigation. Perform final review/update the complaint record and close as per defined timelines. Ensure acknowledgement of Complaint and/or response letter to Complainant (As applicable). Health authority called-in complaints, prioritized complaints and suspected counterfeit complaints are handled with the utmost urgency and in strict compliance with both global and country-specific regulatory requirement. Maintain compliance with all relevant regulatory requirements for complaint management and reporting. Consulting to FAR team in case of any filed alert expected (as applicable). About you: Experience: 3 – 7 years of related experience in the pharmaceutical industry. Knowledge of cGMP’s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience of working on manufacturing sites is an added advantage. Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment. Education: Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering. Languages: Verbal and written fluency in English Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas.

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1.0 - 3.0 years

0 Lacs

Kolkata, West Bengal, India

On-site

Project Role : Safety Associate Experience Required : 1 to 3 years Work Location : Kolkata Work Mode : Office-based Shift Timings : 5 AM to 2 PM / 2 PM to 11 PM (Rotational Shifts) Must-Have Skills : ICSR case processing, Argus database, Drug safety Job Overview Review, assess, and process safety data and information across service lines. Distribute reports/data to internal and external parties. Follow applicable regulations, SOPs, and internal guidelines. Work under the guidance of senior operations team members. Job Responsibilities Prioritize and complete assigned trainings on time. Process safety data per regulations, guidelines, SOPs, and project requirements. Perform pharmacovigilance activities including: Collecting and tracking incoming Adverse Events (AEs)/endpoint information. Determining initial/update status of events. Database entry and AE/product coding. Writing narratives and literature-related activities. Meet quality, productivity, and delivery standards. Ensure compliance with all project-related processes and activities. Create, maintain, and track cases as per project plan. Identify and escalate quality issues to senior team members. Demonstrate problem-solving capabilities. Mentor new team members if assigned. Attend project meetings and provide feedback to the operations manager. Ensure 100% compliance with people practices and processes. Perform other duties as assigned. Technical Skills Medical Terminology : Good knowledge – Intermediate Safety Database : Working knowledge – Beginner Regulatory Requirements : Basic knowledge – Beginner Attention to Detail & Accuracy : Excellent – Beginner Microsoft Office & Web Applications : Good working knowledge – Beginner Organizational & Time Management Skills : Strong – Beginner Communication Skills : Strong verbal/written – Intermediate Self-Motivation & Flexibility : Demonstrated – Intermediate Independence & Initiative : Ability to follow instructions and work independently – Intermediate Multitasking & Prioritization : Capable – Beginner Delegation : Ability to delegate to junior team members – Beginner Learning Agility : Willingness to learn new skills – Beginner Teamwork & Collaboration : Effective team player – Beginner Quality Assurance : Ensure quality of deliverables – Beginner IQVIA Core Values : Demonstrated in daily tasks – Beginner Communication Tools : Extensive use of phone and face-to-face – Beginner Work Conditions : Regular sitting for extended periods – Beginner Occasional travel – Beginner Flexibility to work in shifts – Beginner Educational Qualification B.Pharm / M.Pharm / Pharm.D High School Diploma or equivalent in scientific or healthcare discipline or allied life sciences – Required Bachelor’s Degree in scientific or healthcare discipline or allied life sciences with 1–1.5 years of relevant experience – Required

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0 years

0 Lacs

Kolkata, West Bengal, India

On-site

Project Role: Operations Specialist 2 Work Experience: 5 plus years. Work location: Kolkata Work Mode: Office based Must Have Skills: ICSR case processing, argus database, Drug safety Job Overview: Apply knowledge and expertise including complex decision-making activities to review, assess and process Safety data and information across service lines. Recognized as specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff. Job Responsibilities Process safety data per regulations, guidelines, SOPs, and project requirements. Perform pharmacovigilance activities including: Collecting and tracking Adverse Events (AEs)/endpoint information. Determining initial/update status of events. Database entry and AE/product coding. Writing narratives and literature-related tasks. Quality review, reconciliation, case closure, and translation coordination. Create, maintain, and track cases as per project plan. Perform adjudication-related activities as applicable. Assess safety data for reportability and report to relevant authorities within timelines. Liaise with stakeholders for expedited reporting and regulatory tracking. Contribute to or lead deliverables in Safety Publishing, Risk Management, Safety Surveillance, and Medical Information. Meet quality, productivity, and delivery standards. Ensure compliance with project processes and activities. Foster a collaborative team environment and mentor junior team members. Assist Operations Manager as needed. Share technical and process knowledge with Safety Management and operational teams. Provide oversight and understand team metrics, productivity, and initiatives. Maintain thorough understanding of project protocol, therapeutic indication, budget, and scope of work. Set up and maintain project files, templates, databases, and workflows. Communicate effectively with team and stakeholders on project performance and challenges. Provide feedback to junior team members. Read and acknowledge all required SOPs and complete training on time. Participate or lead trainings across Safety service offerings. Join working groups for new initiatives and process improvements. Demonstrate problem-solving capabilities. Liaise with cross-functional teams and healthcare professionals to resolve project issues. Attend project meetings and provide feedback to Operations Manager. Communicate with clients on daily activities as needed. Contribute to departmental goals. Perform other duties as assigned. Ensure 100% compliance with people practices and processes. Perform medical review of non-serious AEs/ADRs as required, ensuring data accuracy and completeness. Technical Skills Excellent knowledge of medical terminology – Intermediate. In-depth knowledge of Safety Database and internal/client applications – Advanced. Strong understanding of global/regional/local clinical research regulations – Advanced. Excellent organizational, time management, attention to detail, and accuracy – Advanced. Maintain high quality standards – Advanced. Proficient in Microsoft Office and web-based applications – Intermediate. Effective project management and leadership skills – Intermediate. Strong mentoring and coaching abilities – Advanced. Excellent verbal and written communication – Advanced. Self-motivated, flexible, and adaptable to process changes – Advanced. Willingness to learn new skills across Safety service lines – Advanced. Ability to work independently within policies and practices – Advanced. Capable of multitasking, meeting deadlines, and managing priorities – Advanced. Skilled in task prioritization and delegation – Advanced. Effective communication and relationship-building with coworkers, managers, and clients – Advanced. Team player with a focus on team goals – Advanced. Sound judgment and decision-making – Advanced. Ability to manage multiple projects and team priorities – Intermediate. Ensure deliverable quality per agreed terms – Advanced. Demonstrate IQVIA core values in daily tasks – Advanced. Plan workload based on capacity and adjust priorities – Intermediate. Negotiate and find satisfactory solutions for stakeholders – Intermediate. Support audit preparedness – Advanced. Effective use of telephone and face-to-face communication – Intermediate. Ability to sit for extended periods – Intermediate. Willingness to travel occasionally – Intermediate. Flexibility to work in shifts – Advanced.

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5.0 years

5 - 7 Lacs

Calcutta

On-site

Job Overview Apply knowledge and expertise including complex decision making activities to review, assess and process Safety data and information across service lines. Recognized as specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff. Essential Functions Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information determining initial/update status of incoming events database entry coding AE and Products, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan. Perform activities related to adjudication as applicable Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting. Liaise with manager for regulatory tracking requirements and electronic reporting. Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate. Ensure to meet quality, productivity and delivery standards per project requirements. Ensure compliance to all project related processes and activities. Build a positive, collaborative team environment with Safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations Manager as a backup when needed. Provide and impart technical and process information to Safety Management and members of operational team on project specific issues. Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives. Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects set up and maintain project files, standard templates, electronic forms, databases and workflow as per project requirement. Establish and maintain effective team and project service operations communications i.e. provide regular feedback to operations team manager and other relevant stakeholders on project metrics, out of scope work challenges/issues and successes effective feedback on project performance to junior members of team. Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring completeness of individual training plan and maintain up to date training transcripts. Participate or Lead trainings across Safety process service offerings participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies. To demonstrate problem solving capabilities. Liaise with different functional team members, e.g. project management, clinical, data management health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues. Attend project team meetings and provide regular feedback/ inputs to Operations team manager on operational project metrics, out of scope work challenges/issues and successes. To liaise with client in relation to details on day to day activities as needed. Contribute to achievement of departmental goals Perform other duties as assigned 100% compliance towards all people practices and processes In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications. Qualifications Bachelor's Degree Scientific or healthcare discipline or allied life sciences Req Bachelor's degree in life sciences or related field and up to 5 years of relevant experience, inclusive of up to 3 years of Pharmacovigilance experience. Req or equivalent combination of education, training and experience. Pref Excellent knowledge of medical terminology. Intermediate In depth knowledge and understanding of applicable Safety Database and any other internal/Client applications. Advanced In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements. Advanced Excellent organizational skills, time management skills, attention to detail and accuracy. Advanced maintain high quality standards. Advanced Excellent working knowledge of Microsoft Office and web-based applications. Intermediate To demonstrate effective project management and leadership skills. Intermediate Effective mentoring and coaching skills. Advanced Excellent verbal/written communication skills. Advanced Self-motivated, flexible, receptive to changing process demands. Advanced willingness and aptitude to learn new skills across Safety service lines. Advanced Proven ability to work independently and autonomously with policies and practices. Advanced Proven ability to multi-task, meet strict deadlines, manage competing priorities. Advanced Ability to identify, prioritize tasks and delegate to team members. Advanced Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Advanced Ability to work as a Team Player, contribute and work towards achieving Team goals. Advanced Demonstrate Sound judgment and decision making skills. Advanced Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams’ priorities. Intermediate Ensure quality of deliverables according to the agreed terms. Advanced Demonstration of IQVIA core values while doing daily tasks. Advanced Skill to plan work load based on available capacity and ability to change prioritization based on workload fluctuations. Intermediate Skill to negotiate and work on finding a central ground that is satisfactory to all concerned stake holders. Intermediate Support audit preparedness Advanced Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate Regular sitting for extended periods of time. Intermediate May require occasional travel. Intermediate Flexibility to operate in shifts. Advanced IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

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1.0 years

0 Lacs

Bharuch, Gujarat, India

On-site

Job Description - Diabetes Educator! Company Name: Kartavya Healtheon Pvt Ltd Contact Number: +91 77009 05394 Experience Required: 1-3 Years Location - Bharuch ,Gujarat Company Overview: Kartavya Healtheon is a Mumbai-based B2B healthcare company dedicated to enhancing patient engagement. Our services encompass organizing in-clinic camps, facilitating patient support programs, and managing specialty pharmacy services. Our mission is to make healthcare accessible for everyone, regardless of location. We are currently partnering with a pharma client to provide essential diabetes education and support to patients. We seek a skilled and compassionate Diabetes Educator to join our dynamic team. Job Overview: The Diabetes Educator will play a vital role in educating and supporting patients with diabetes, empowering them to effectively manage their condition. This position involves working in doctors' clinics and hospitals to provide patient education, counselling, and program enrollment support. Responsibilities: Conduct educational sessions and counseling for patients in doctors' OPD clinics and hospitals regarding diabetes management. Demonstrate insulin pen usage and other diabetes management tools to patients. Build rapport with patients by addressing their queries and concerns effectively. Direct patients to approved pen stations for their convenience. Follow up with patients to monitor therapy initiation and assist with any challenges they encounter. Enroll patients into the program and maintain accurate records in the CRM system. Organize camps and support initiatives in collaboration with healthcare providers. Ensure adherence to pharmacovigilance protocols and compliance guidelines for patient safety. Provide feedback and report to the Reporting Manager on program effectiveness and patient outcomes. Requirements: Bachelor’s degree in a relevant science field, or qualification as a dietitian, or certification as a diabetes educator, with 1 to 3 years of experience in pharmaceutical or allied services, or diet counseling. Strong passion for diabetes education and patient support. Exceptional communication and interpersonal skills. Ability to work independently, manage time efficiently, and maintain flexibility in work hours, including evenings and weekends as necessary. Positive attitude, willingness to learn, and a friendly demeanor. Working Conditions: The Diabetes Educator will work in various settings, including doctors' clinics and hospitals as per roster provided by reporting manager. Flexible working hours, including weekends and holidays, may be required. Note: This position is part of a program for one of our pharma clients, and the selected candidate will be employed by Kartavya Healtheon Pvt Ltd. This job description serves as a general outline of responsibilities and requirements for the position. It is not exhaustive, and additional duties may be assigned based on business needs.

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7.0 - 12.0 years

0 Lacs

Noida, Uttar Pradesh, India

Remote

Position: Team Lead-SOC, Noida Department: Information Technology | Role: Full-time | Experience: 7 to 12 Years | Number of Positions: 1 | Location: Noida Skillset: SOC Lead, Team Lead, Threat monitoring, Cyber Security, Forensics Services, Audit Trails, SIEM, ITSM Tools, Excellent English communication skills Job Description: We are seeking for SOC Lead to support threat monitoring, detection, event analysis, incident response/reporting, brand monitoring, forensics and threat hunting activities for its SOC, which is a 24/7 environment. The individual must be able to rapidly respond to security incidents and should have at least 7 years of relevant experience in Cyber security incident response. Should have deeper understanding with some hands-on experience on enterprise IT infra components such as advanced firewalls, IPS/IDS/WIPS/HIPS, routers/switches, TACACS, VPN, proxy, AV/EDR, DNS, DHCP, multi factor authentication, virtualization, Email systems/security, Web Proxy, DLP etc. along with cloud environments like AWS (Must), Azure etc. Responsibilities: • Should be able to manage a SOC L1/L2 team • Providing incident response/investigation and remediation support for escalated security alerts/incidents • Work with various stakeholders for communicating and remediating the cyber incidents • Use emerging threat intelligence IOCs, IOAs, etc.to identify affected systems and the scope of the attack and perform threat hunting, end user’s systems and AWS infrastructure • Provides support for complex computer/network exploitation and defense techniques to include deterring, identifying and investigating computer, applications and network intrusions • Provides technical support for forensics services to include evidence capture, computer forensic analysis and data recovery, in support of computer crime investigation. • Should be able to safeguard and custody of audit trails in case of any security incident • Researches and maintains proficiency in open and closed source computer exploitation tools, attack techniques, procedures and trends. • Performs research into emerging threat sources and develops threat profiles. Keep updated on latest cyber security threats. • Demonstrates strong evidence of analytical ability and attention to detail. Has a broad understanding of all stages of incident response. • Performing comprehensive computer monitoring, identifying vulnerabilities, Target mapping and profiling. • Has a sound understanding of SIEM (Splunk, Datadog, Arcsight etc), PIM/PAM, EDR, O365 security suite and other threat detection platforms and Incident Response tools. • Should have knowledge of integrating security solutions to SIEM tool and crate the use cases as per the best practices and customized requirements • Has knowledge on working on ITSM tools such as JIRA, Service NOW etc • Has a logical, disciplined and analytical approach to problem solving • Has knowledge of current threat landscape such as APTs • Has basic knowledge of Data Loss Prevention monitoring • Has basic knowledge of audit requirements (SOC2, HIPPA, ISO27001, etc.) • Should be flexible to work in 24*7 environment Preferred qualifications: Security Certifications Preferred (but not limited to): CISSP, CHFI, CEH Additional Information: • This is 5 days work from office role.(No Hybrid/ Remote options available) • There are 2-3 rounds in the interview process. • Final round will be F2F only (Strictly) Required Qualification: Bachelor of Engineering - Bachelor of Technology (B.E./B.Tech.) - IT/CS/E&CE/MCA With a Top Pharmacovigilance IT Products MNC

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4.0 years

0 Lacs

Mumbai, Maharashtra, India

On-site

Job Title: Manager, Consulting – Pharmaceuticals / R&D Procurement Location: Mumbai Experience Level: 4+ years in procurement consulting, with at least 2-3 years focused on pharmaceutical R&D categories Required Qualifications: MBA / PGDM preferred, ideally with a background in Life Sciences, Supply Chain from Tier -1 Colleges Strong understanding of R&D procurement in pharmaceuticals / life sciences Experience across some or most of these categories in R&D Procurement - Discovery, Pre-Clinical, Clinical (Phases I–III), Pharmacovigilance, Regulatory & Phase IV, and Commercialization & Support Services Proven experience in managing complex sourcing projects and stakeholder engagement Excellent analytical, communication, and negotiation skills Prior consulting experience with global pharma clients preferred Role Overview: We are looking to hire a Consulting Manager with deep expertise in procurement consulting for R&D categories in the pharmaceutical industry . This role will involve managing end-to-end category strategy and agile sourcing for categories across Discovery, Pre-Clinical, Clinical (Phases I–III), Pharmacovigilance, Regulatory & Phase IV, and Commercialization & Support Services Key Responsibilities: Develop and Execute R&D Procurement Category Strategies Build and implement sourcing strategies across Discovery, Clinical, Regulatory, and Commercialization categories in alignment with client goals. Drive Sourcing Initiatives Lead end-to-end sourcing projects including RFx design, supplier outreach, evaluation, and contracting support. Analyze spend and market data to identify cost-saving and value-creation opportunities; support negotiation planning and execution. Collaborate with Stakeholders Engage cross-functional stakeholders including R&D, medical affairs, market access, and procurement to ensure alignment and adoption. Support Supplier Selection and Contract Finalization Conduct TCO and value-based supplier evaluations, facilitate supplier negotiations, and support transition to contract execution. Provide Market and Category Intelligence Leverage internal benchmarks and SME support to bring best practices and insights into client decision-making. Ensure Governance and Compliance Monitor sourcing project performance, support KPI tracking, and ensure alignment with contractual and regulatory frameworks. Categories Supported: Clinical Trial Services, CROs, Laboratory Supplies, Pharmacovigilance, Regulatory Services, Medical Affairs, Market Access, Pricing & HEOR Interested canidates please share your CV on mehek.shaikh@gep.com

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0 years

0 Lacs

Chennai, Tamil Nadu, India

On-site

PV Reporting Associate 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 Associate to join our diverse and dynamic team. As a Pharmacovigilance Associate at ICON, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. Your attention to detail and understanding of regulatory requirements will be essential in supporting the organization’s commitment to patient safety and compliance. What You Will Be Doing Collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. Conducting signal detection and risk assessment activities to identify potential safety issues. Collaborating with cross-functional teams to support safety-related inquiries and investigations. Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. Assisting in the preparation of safety reports and regulatory submissions. Your Profile Bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred. Experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment. Strong analytical skills with attention to detail in data collection and reporting. Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders. A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities. 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. 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

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2.0 years

0 Lacs

Chennai, Tamil Nadu, India

On-site

This job is with Pfizer, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. 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

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0 years

0 Lacs

Hyderabad, Telangana, India

On-site

Responsible for research and authoring of scientific response documents under the direction of the Global Medical Information (GMI) team in support of global and local medical information activities. Responsible for the execution of activities as required in alignment with GMI colleagues. Achieved through a combination of product knowledge, along with editing, writing, and document management proficiency. Essential Job duties and responsibilities: 1) Conducts literature searches and reviews, and extracts/summarizes complex data from the scientific literature. 2) Generates evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of scientific response documents for products in designated therapeutic area(s). 3) Adapts global scientific response documents for assigned countries. 4) Develops responses to escalated inquiries for assigned countries. 5) Develops contributions to US NDA Annual Reports. 6) Contributes to US compendia reviews. 7) Contributes to peer reviews. 8) Demonstrates resolve and urgency to accomplish tasks without direct authority or control. Participate in cross-functional project teams as needed. Ensure that assigned projects are completed on schedule. 9) Develops and maintains Therapeutic Area expertise. 10) Reviews the content created by peer writers. 11) Collaborates effectively with Global Medical Information teams to execute content plans People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical information content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical information writers in developing knowledge and sharing expertise. Performance: Provide deliverables (scientific response documents, US NDA Annual Reports, US compendia reviews) as per agreed timelines and quality Process: 1) Act as an expert in the field of medical information writing and maintain on the regulatory requirement for countries supported. 2) Assist the assigned medical information team in conducting a comprehensive medical writing needs analysis. 3) Implement relevant elements of content plans and associated activities for the year identified for the assigned countries. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. Stakeholders: 1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Liaise with the Medical department to prepare relevant & customized deliverables. null Pursue Progress . Discover Extraordinary . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

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2.0 - 4.0 years

0 Lacs

India

On-site

ProductLife Group is looking for Medical Reviewers having 2-4 years of experience in Pharmacovigilance Medical Reviewing. 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 organization skills Punctual Database experience

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0.0 - 8.0 years

0 Lacs

Worli, Mumbai, Maharashtra

On-site

Site Name: India - Maharashtra - Worli Mumbai Posted Date: Jul 23 2025 Job Title: Patient Support Program (PSP) Manager – Oncology Location: Mumbai Role Summary: As the PSP Manager – Oncology, you will be responsible for the seamless execution of GSK’s Patient Support Program (PSP) and Value-Added Services for oncology products. This includes overseeing patient onboarding, ensuring program compliance, enhancing patient centricity, and ensuring eligible patients gain timely access to GSK’s innovative oncology therapies. You will work closely with PSP partners, Patient Assistance Program (PAP) service vendors, and PAP distributors to ensure high-quality, compliant, and patient-focused delivery. Key Responsibilities: Program Execution & Oversight: Ensure the end-to-end implementation of the PSP in alignment with GSK policies and access strategy. Oversee the operations and deliverables of the PSP partner to ensure adherence to SLAs, timelines, and patient care standards. Patient Onboarding & Governance: Monitor patient onboarding processes to ensure robust due diligence and documentation in compliance with applicable SOPs and regulations. Conduct periodic audits and quality checks to verify eligibility, authenticity, and completeness of patient records. Vendor Management: Coordinate effectively with the PSP service provider and PAP distributor to ensure smooth supply chain and access management. Evaluate vendor performance periodically and initiate improvements where necessary. Governance & Compliance: Uphold governance standards related to data privacy, pharmacovigilance, and ethical conduct within the PSP framework. Ensure timely reporting and resolution of any discrepancies, risks, or deviations. Patient-Centric Approach: Enhance patient experience by ensuring empathetic, timely, and clear communication through the PSP. Identify and implement opportunities to improve service quality, reduce delays, and address barriers to access. Cross-functional Collaboration: Work closely with Access, Medical, Legal, Regulatory, and Commercial teams to ensure aligned execution and continuous improvement of the PSP. Qualifications & Experience: Bachelor’s degree in Life Sciences, Pharmacy, or related discipline; MBA or post-graduate qualification preferred. 5–8 years of experience in managing PSPs or access-related programs in the pharmaceutical/healthcare industry. Strong knowledge of oncology therapies and patient access challenges. Experience with vendor governance, auditing, and compliance practices. Skills & Competencies: Deep understanding of patient access models and reimbursement landscapes. High attention to detail and integrity in patient handling and documentation. Strong project management and coordination skills. Excellent stakeholder engagement and communication abilities. Ability to handle sensitive patient information with discretion and compliance. Why GSK Oncology? At GSK, we are transforming the treatment paradigm in oncology by delivering innovative, science-driven therapies to patients in need. Join us in ensuring that every eligible patient has access to life-changing innovation with empathy, integrity, and excellence. 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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.

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0.0 years

0 Lacs

Mumbai, Maharashtra

On-site

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. Sr Medical Advisor - Oncology POSITION PURPOSE: The position is responsible for the medical and scientific support, including technical advice to the Business Units and Pharmacovigilance/ Medical Information and Clinical Research teams in their assigned therapeutic areas. The position holder oversees the Medical Affairs function in India in their assigned therapeutic/product areas and cooperates with Regional Medical Affairs functions and relevant Global Medical Affairs functions. This position holder is responsible for ensuring that marketing and sales functions have appropriate medical scientific support and training (the latter in co-operation with the Training department). To enable this support, product and development project information is to be kept up to date based on internal publications and communication with regional and global Medical Affairs functions as well as based on review of pertinent scientific publications. In addition to this, the position holder is responsible for the review process of promotional materials in the respective area according to the global SOP and local laws and compliance. The tasks also include monitoring of medical marketing activities of competitors locally and worldwide and close interaction especially with regional medical affairs functions. The position holder will further support regulatory, PV/MI and CR teams in medical scientific questions and prepare and give internal (mainly marketing and sales functions) and possibly external presentations (local advisory board meetings, launch symposia and others) to enhance the medical knowledge of development projects and marketed products. This also includes interaction and relationship-building with TLs. YOUR TASKS AND RESPONSIBILITIES : Medical Marketing Provide timely and appropriate medical review of all promotional material as well as challenging promotional activities of competitors where appropriate. Support BUs in transforming medical data into marketing strategy Work closely with other members of the medical team (especially the MSLs) to support the business Build up good relationships with customers and TLs Build strong relationships with internal customers (marketing and sales) and with regional / global Medical Affairs Provide development project and product training internally to marketing and sales functions and externally to doctors Support and educate internal customers in compliance with the Country’s Code of Conduct Provide a comprehensive and proactive Medical service that encompasses, as appropriate, including Medical Support, Medical Information and Pharmacovigilance As Senior Medical Advisor, is responsible for overall medical inputs to Integrated Brand Plans of assigned therapeutic areas, provision of scientific expertise, review of promotional materials, thought leader management, speaker development and training. Takes responsibility for study development programmes of the Business units within portfolio (included local studies NIS, IIR). Identifies, initiates and completes agreed study development activities in a timely manner, be IIR responsible of local IIR. Takes responsibility for all study development activities that they are running in accordance with all applicable external and internal regulations and guidelines. Play a role as local medical expert for Global Clinical Development by providing inputs for medical queries related to trials; participate in site feasibility. Respond to all external scientific and medical queries from physicians, regulatory authorities and public alike in an accurate, transparent and convincing manner in order to position Bayer as a credible, trustworthy and professional leader in the industry. Support the Local Safety Issue and Crisis Management in collaboration with the Headquarters. Support the local Safety Management Team. Reviews all local patient support programs and other undertakings of the local organization with potential consequences on PV obligations (e.g. Market Research, Active-Online-Listening programs) to ensure Pharmacovigilance principles are applied in the interaction with patients. Develops, maintains and strengthens strategic partnership with relevant TLs, societies and associations. Act as medical contact for TL and external Medical experts. In collaboration with local marketing to develop, conduct Advisory Board meetings, Congress and Symposia. WHO YOU ARE: Certified Medical Doctor from a recognized Medical University (MBBS and MD in Pharmacology). More than three (3) years’ of experience as Medical Advisor in Oncology or Hematology Have in depth Disease Area expertise and technical knowledge in the assigned therapeutic areas. For the role is desirable: Experience in driving and managing the medical strategy for Specialty therapy area like Oncology or Hematology. Clinical trial management experience, and be able to interact authoritatively with key stakeholders and investigators. Excellent presentation and teaching skills and to represent the company in a professional manner at medical, scientific and public events. Independent, self-driven, pro-active, collaborative and customer focused. Ability to form relationships quickly and have demonstrable persuasive abilities Highly effective communicator both orally and in writing; can get ideas across one-on-in, in group settings as well as in presentations Highly organized with attention to detail Strong team player and know how to collaborate and engage many stakeholders across a large organization Solid negotiation and decision-making skills Good analytical and numerical abilities Adaptability Innovative Strategic thinking Results-oriented attitude Experience in working with MS office in a Windows environment Willing to travel Ever feel burnt out by bureaucracy? Us too. That's why we're changing the way we work- for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https://www.bayer.com/enfstrategyfstrategy Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext. Please don’t rely upon any unsolicited email from email addresses not ending with domain name “bayer.com” or job advertisements referring you to an email address that does not end with “bayer.com”. For checking the authenticity of such emails or advertisement you may approach us at HROP_INDIA@BAYER.COM. YOUR APPLICATION Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination. Location: India : Maharashtra : Mumbai Division: Pharmaceuticals Reference Code: 850670 Contact Us + 022-25311234

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10.0 - 14.0 years

0 Lacs

noida, uttar pradesh

On-site

As a Product Manager at RxLogix, your role will involve defining and managing use cases, business requirements, functional requirements, and acceptance criteria for RxLogix product features. You will be responsible for managing the product backlog and release scope items, including Epics, Stories, and Bugs in JIRA. Collaboration with other team leads and members is essential to ensure timely and quality release of various product deliverables using Agile methodology as per RxLogix SDLC. In this position, you will guide internal product engineering team members on domain-specific knowledge, product features, and requirements. Your responsibilities will also include conducting and leading user consortiums and workshops with clients to present upcoming product features and gather their inputs and feedback. Furthermore, you will work closely with the Engineering team to define and build prototypes that demonstrate new product features and concepts, allowing for early feedback from clients, sales team, and other stakeholders. Support for product implementation teams and clients during implementation projects is also a key aspect of this role. Your educational background should include a Bachelors/Masters degree in Technology from a reputed college, along with a minimum of 10 years of experience in the software product development industry and at least 5 years in the Pharmacovigilance domain. It is essential to have at least 3 years of experience in a product management role. A strong knowledge of the pharmacovigilance domain and key regulations such as 21 CFR Part 11, HIPAA, E2B R2/R3 from ICH, EMA, FDA, PMDA, eMDR, and eVAERS is required. Additionally, expertise in enterprise-class web-based applications and RDBMS database technologies like Oracle is essential for this role. Exceptional communication, documentation, presentation, and analytical skills are necessary, along with the ability and experience to lead and present to clients at major conferences and user group meetings. Coordination and negotiation skills are crucial for interactions within RxLogix with various departments, senior management, leads, peers, and team members from different cross-functional teams. Experience working in an Agile software development SDLC with Epics and Story-driven product management is highly valued. The ability to work effectively under pressure, handle multiple tasks simultaneously, and deliver on-time with quality is important. Personal qualities such as ownership, integrity, assertiveness, dedication, teamwork, and attention to detail will contribute to success in this role. Willingness to travel for short business trips within the country and to other countries to meet clients and internal stakeholders is a requirement for this position.,

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1.0 - 2.0 years

0 Lacs

Chennai, Tamil Nadu, India

On-site

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us. Your Role Generate or convert doctors for our product portfolio. Secondary sales – Ensuring to achieve secondary sales targets through prescription generation by each of his BE. Good at relationship with KOLs (Top Physicians, Endocrinologists & Cardiologists) Day to day sales reporting Effective query handling and customer queries. Ensuring 100% Implementation of Company’s strategies Pharmacovigilance (Adverse Event Reporting) – To collect adverse drugs reaction (ADR) incidences including lack of efficacy related to medicinal products up to the maximum possible level of completeness and forward to local Patient Safety team immediately within 24 hours of ADR awareness. The additional information can be submitted as soon as possible Who You Are Any graduate Freshers or minimum of 1-2 years of experience in any pharma company Should have strong product knowledge & communication skills What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team!

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5.0 years

0 Lacs

Nashik, Maharashtra, India

On-site

OSS is a growing staffing and recruitment firm specializing in delivering top-notch talent solutions across industries. We are currently seeking an experienced and driven Pharma Recruiter to join our dynamic team and help our clients find the best talent in the pharmaceutical and life sciences domain. As a Pharma Recruiter , you will be responsible for sourcing, screening, and placing qualified candidates in pharmaceutical roles such as R&D, regulatory affairs, clinical research, quality assurance, pharmacovigilance, and manufacturing. You will work closely with hiring managers and account teams to understand job requirements and deliver timely recruitment solutions. Key Responsibilities: Partner with clients and internal teams to understand pharma-specific hiring needs. Source candidates through job boards, social media, professional networks, referrals, and internal database. Conduct in-depth screening interviews to evaluate technical skills, experience, and cultural fit. Maintain a pipeline of qualified candidates for current and future openings. Manage the full recruitment life cycle—from sourcing to offer negotiation and onboarding. Stay updated on industry trends, market salary data, and regulatory compliance. Ensure a positive candidate experience throughout the hiring process. Maintain accurate records in the applicant tracking system (JOBDIVA). Qualifications: Bachelor’s degree in life sciences, HR, or related field (preferred). 1–5 years of recruiting experience in the pharmaceutical/biotech/life sciences industry. Strong understanding of pharma-related roles and terminology. Proficiency with sourcing tools. Excellent communication, interpersonal, and organizational skills. Ability to work in a fast-paced and dynamic environment. Experience with Applicant Tracking Systems (ATS) is a plus. Why Join Us? Competitive salary + performance incentives Opportunity to work with leading pharma clients Collaborative and growth-oriented work culture Continuous learning & development support

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4.0 years

0 Lacs

Kukatpalli, Telangana, India

On-site

Location: Kukatpally, Hyderabad Company: ClinEdify Solutions Pvt. Ltd. Experience Required: 4+ years in EdTech Sales & Team Management Employment Type: Full-time CTC: [As per industry standard / Negotiable] About Us: ClinEdify is a dynamic and fast-growing EdTech startup revolutionizing education in clinical research, pharmacovigilance and medical domains. We’re building India’s most career-oriented life sciences training ecosystem. We are looking for a high-performing Sales Head to join our leadership team and drive the company’s sales growth from day one. Role Overview: We are seeking an experienced and passionate Sales Head with a strong track record in EdTech sales, marketing strategy, team leadership, revenue generation and startup growth handling. You will be responsible for developing and executing scalable sales strategies, building and leading the sales team and driving exponential growth from zero to scale. Key Responsibilities: Sales Leadership : Build, mentor and manage the sales team to achieve ambitious monthly and quarterly revenue targets. Revenue Generation: Take full ownership of revenue KPIs. Consistently meet or exceed sales quotas through effective pipeline management. Marketing Strategy: Collaborate with the marketing team to design and implement lead generation, funnel optimization, and campaign strategies. Startup Execution: Manage day-to-day operations with an agile mindset. Be hands-on and adaptable to startup challenges and rapid changes. Sales Funnel Management: Design, track and optimize sales funnels to improve conversion rates and lead nurturing. Lead Generation: Leverage CRM tools, LinkedIn, cold outreach and inbound channels to ensure a strong lead pipeline. Reporting: Monitor team performance, generate detailed reports and make data-driven decisions to improve results. Cross-Functional Collaboration: Work closely with Founders, Product and Training teams to align sales strategies with business goals. Client Engagement: Maintain strong relationships with B2B and B2C clients. Ensure customer satisfaction and retention. Requirements: Minimum 4 years of EdTech or B2C sales experience, with at least 2 years in a leadership/managerial role. Proven track record of revenue generation and team scaling. Strong experience in digital marketing strategy and lead funnels. Entrepreneurial mindset – must be comfortable working in a fast-paced startup environment. Excellent communication, negotiation and closing skills. Experience with CRM tools (Zoho, HubSpot, etc.) and sales analytics. High ownership and a positive, growth-oriented attitude. Ability to start and scale from Day 1 with a fresh team. Preferred Qualifications: MBA in Marketing / Sales / Business or equivalent experience. Experience in the clinical research, life sciences or education industry is a strong plus. Exposure to bootstrapped or early-stage startup environments. What You’ll Get: Opportunity to be a core part of a growing EdTech brand. Fast-track career growth into leadership or CXO roles. Performance-based incentives and ESOP opportunities (if applicable). Dynamic work environment with flexibility and ownership. To Apply : immediate joiners, send your updated resume and a brief pitch on why you're the right fit to info@clinedify.com contact: 9032560517

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