1759 Pharmacovigilance Jobs - Page 42

Mega Walk-in Interview for Medical Record Summarizer - Day Shift @ Taramani(Chennai) Position : Associate Job Location: Chennai - Taramani Job Type : Permanent Role Duration : Full - Time Work Timings : Work From Office - Day Shift - 8AM to 5PM Working Days: Monday - Friday Salary - 15K Takehome + Incentives Job Specifications:- Need to review medical records. Eliminate non medical documents as per process guideline. Prepare document as per client specification. Should have good knowledge in Anatomy and Physiology. Eligibility:- Fresh graduates are only eligible. Only Life Science Graduates UG/PG both can apply ( Bio-Technology, Microbiology, Bio-Chemistry, Bio-Medical Engineering & Pharmacology / Physiotherapy). Walkin Interview details Date: 14-June-2025(Saturday) Time - 10am to 3pm Location: eNoah iSolution India Pvt Ltd, Elnet Software City, Admin Block, 1st floor , Rajiv Gandhi Salai, Tharamani, Chennai, Opposite to Thiruvanmiyur Railway Station. Near ICICI ATM Regards, Pavithra V HR - eNoah Ph: 7708660402

Job description: Job Description Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. ͏ Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLA’s defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements ͏ Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers’ and clients’ business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs ͏ Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks ͏ Deliver NoPerformance ParameterMeasure1ProcessNo. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback2Self- ManagementProductivity, efficiency, absenteeism, Training Hours, No of technical training completed Mandatory Skills: Pharmacovigilance & Drug Safety(Pharma) . Experience: 1-3 Years . Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome. Show more Show less

Job description: Job Description Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. ͏ Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLA’s defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements ͏ Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers’ and clients’ business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs ͏ Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks ͏ Deliver NoPerformance ParameterMeasure1ProcessNo. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback2Self- ManagementProductivity, efficiency, absenteeism, Training Hours, No of technical training completed Mandatory Skills: Pharmacovigilance &DrugSafety(Med Device . Experience: 1-3 Years . Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome. Show more Show less

We are looking for an MSL- Oncology for a Global Pharmaceutical MNC Profile: Medical Science Liaison- Oncology Location: Delhi/ Kolkata (2 openings) Qualification: MD Pharmacology with minimum 6 months of experience in solid cancers MDS/ PhD with minimum 1yr of Oncology experience as MSL/RMA MD Pharmacology with clinical experience in Oncology can apply too Job Purpose: The Medical Science Liaison (MSL) will establish the company’s medical affairs presence with external stakeholders through scientific exchange and research support in oncology. The focus will be on licensed and non-licensed products for hard-to-treat cancers, including metastatic pancreatic cancer, cholangiocarcinoma, digestive cancers (such as stomach cancer, pancreatic cancer, and cholangiocarcinoma), glioma, brain tumors, hematologic cancers (acute myeloid leukemia, acute lymphoblastic leukemia, and lymphoma), and pediatric cancers. This role is field-based, covering the India region. The MSL will communicate balanced therapeutic area-related, product-related, and clinical information to external stakeholders (e.g., physicians, academic institutions, hospital formulary committees), respond to unsolicited requests for medical information, facilitate research discussions, and bring key insights from the medical and scientific community to internal stakeholders. The role also involves ensuring compliance with all company procedures, confidentiality standards, and contributing to business success with a focus on patient safety. Principal Accountabilities: 1. Exchange of Medical and Scientific Information: Responsible for communicating fair and balanced therapeutic area-related, product-related, and clinical information to external stakeholders. Execute the scientific engagement plan in alignment with the Therapy Medical Plan. Proactively develop long-term peer-to-peer relationships with opinion leaders and relevant stakeholders. Respond to unsolicited requests for medical information, including off-label data, related to marketed products and pipeline products. Provide clinical and medical presentations to external stakeholders as needed. Disseminate updates from scientific meetings and report information of strategic interest to cross-functional teams. 2. Supporting Clinical Research: Support ongoing and future Medical Affairs Company-Sponsored Studies, providing country-level review of proposed research site lists, attending site visits if necessary, and providing feedback to the line manager. Support unsolicited requests for investigator-initiated trials (IITs) proposals by offering appropriate investigator support as per company SOPs. Assist in the development and support of national disease registries and Real-World Evidence (RWE) projects as necessary. 3. Contributing to the Organization through Medical Expertise & Market Insights: Maintain up-to-date knowledge of scientific/medical developments in the relevant therapeutic area through literature searches, clinical papers, conferences, and other relevant events. Capture and share in-field insights to develop territorial Field Medical Plans and support medical and scientific strategies. Provide medical and scientific expertise to commercial partners within regulatory guidelines. Act as a field-based scientific and clinical reference for internal stakeholders (e.g., sales, market access) through training and ad-hoc support. 4. Cross-Functional Collaboration: Support the development of medical/scientific materials, ensuring content is reviewed and approved according to company policies. Contribute to the development and execution of the regional medical affairs strategy and action plan in collaboration with field departments such as Sales, Clinical Research, and Market Access. Keep medical representatives and their managers informed about the latest scientific developments. Support the market access strategy at a regional level, including hospital listings, in coordination with the market access manager. 5. Compliance with External Regulations and Company Policies: Maintain a high level of scientific, clinical, and environmental knowledge through courses, self-learning, and attendance at relevant meetings. Stay informed about regulations related to medical information services in the pharmaceutical industry. Ensure all activities comply with internal and external codes of conduct, prioritizing patient safety by following pharmacovigilance processes. Support the company’s reputation in the field by adhering to industry regulations. 6. Patient-In Activities: Support patient awareness initiatives, both physical and digital. Contribute to the Patient-In strategy, understanding the patient journey in coordination with therapeutic area experts, and set up Patient Support Programs (PSPs) to improve patient outcomes as per local regulations. General Administration: Complete all required administration within the specified timelines. Submit monthly reports and expenses by the second working day of each month. Ensure timely completion and submission of all required documentation to the Head Office as appropriate. Profile Requirements A] Minimum Requirements: Education: MBBS/MD Minimum 1-2 years of working experience in oncology. B] Indispensable Qualities: Strong ability to learn new subjects and environments comprehensively. Excellent written and spoken communication and presentation skills, with the ability to build and maintain collaborative relationships with opinion leaders, physicians, and other healthcare decision-makers. Substantial business acumen and autonomy in managing priorities and activities. Strong commitment to compliance with relevant rules and procedures, as well as scientific integrity and quality. Ability to manage cross-functional projects effectively. Leadership skills, emotional intelligence, active listening, and strength of conviction. Negotiation and problem-solving abilities. Proficiency in English is essential. Ability to innovate and execute strategies effectively. Relevant candidates can share their CV at pooja.j@domniclewis.com Show more Show less

Essential Skills/Experience: Degree Qualified - Pharmacy/ Medical/ Science Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry Thorough knowledge of the current pharmacovigilance and regulatory developments Experience in working cross-functionally Ability to set and manage priorities, resource goals and project initiatives Ability to influence strategically to obtain desired outcomes while maintaining effective, positive organisational relationships Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience: Degree Qualified - Pharmacy/ Medical/ Science Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry Thorough knowledge of the current pharmacovigilance and regulatory developments Experience in working cross-functionally Ability to set and manage priorities, resource goals and project initiatives Ability to influence strategically to obtain desired outcomes while maintaining effective, positive organisational relationships

Leads Implementation of statistical programming aspects of the protocol or clinical development program Responsible for the high quality of all project deliverables, holding partners and providers accountable for the quality of their deliverable and/or technical subject matter expert for aspect(s) of the TA, Project, or function Leads or contributes to cross-functional administrative or process improvement initiative(s) Drives the development of best practices to improve quality, efficiency, and/or effectiveness within the function Drives standards development and implementation Manages and escalates risk in complicated or novel situations within their study and/or projects Provides Programming expertise to the team Provides tactical input and/or drives ideas and improvements Contributes to the function by supporting recruiting and/or providing training and mentorship Finds opportunities to improve methodology and provides practical solutions for problems Manages activities of our external partners (i.e., Contract Research Organisations) Influences collaborators by providing subject matter expertise on programming-related items Ensures compliance with standards and automation usage Employs all project management practices in managing drug or technical projects Provides input to capacity management for all projects in scope Maintains expertise in the latest industry and regulatory requirements to stay current Essential Skills/Experience Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science or equivalent Proven programming expertise Thorough knowledge of the clinical development process Thorough knowledge of industry standards and ability to implement them Ability to apply programming expertise to problem-solving and troubleshooting for teams Current knowledge of technical and regulatory requirements relevant for the role Ability to proactively manage concurrent activities within a project Proficient ability to influence relevant stakeholders on programming-related items Ability to manage risk in complicated or novel situations Project Mindset

Essential Skills/Experience: PhD or Masters or equivalent experience in a relevant scientific field with 4+ years of industrial experience. A strong background in pharmacology (e.g., pharmacology, biology, biochemistry, toxicology, physiology) with a proven track record in driving innovative science, preferably in the pharmaceutical or biotechnology industry. Technical experience in in vitro pharmacological or biochemical assay development and screening (e.g., kinase profiling technologies, radioligand binding, enzyme activity, and functional cell-based systems) applied to various biological target classes. Excellent problem-solving and organisational skills, delivery focus, and outstanding communication skills. A true collaborator with highly effective networking skills and experience collaborating across scientific disciplines, cultures, and expertise. Desirable Skills/Experience: Experience with off-target profiling data and strategies in the pharmaceutical industry. Practical understanding of kinase profiling technologies. Experience working with CRO s, commissioning requests and driving delivery processes. Experience with being entrepreneurial taking the initiative in projects. Demonstrated leadership in scientific projects or teams. Experience in regulatory interactions or safety assessments. Knowledge of emerging trends in drug safety and pharmacovigilance.

The SMW will be responsible for authoring the signal management reports including Validations, SERs, HA requests etc. The scientist will support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting this may include and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc. Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO. Conduct/support signal detection and evaluation activities according to SOPs and guidelines Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, procedures and SOPs, and international drug safety regulations Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting Maintaining a good working knowledge of the assigned Clinical studies for narratives Attending/conducting internal, drug safety and project specific training sessions Imparting trainings to the new starts during the induction sessions and the team as required. Skills Analytical and problem-solving skills Excellent interpersonal skills Excellent verbal / written communication skills Excellent organizational and prioritization skills Ability to work collaboratively and effectively in a team environment Client focused approach to work Ability to evaluate data and draw conclusions independently A flexible attitude with respect to work assignments and new learning Ability to negotiate on behalf of the department to ensure resources, timelines and expectations are aligned Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Fluency in written and spoken English Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point) Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Provides departmental expertise and perspectives to promote prospective business opportunities. Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text Typing and transcription accuracy Knowledge And Experience Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field. Good knowledge of medical terminologies Education Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.) A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage Show more Show less

Job Purpose Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products Signal detection/analysis/evaluation and ongoing safety surveillance activities Provide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical aspects of drug safety Function as pharmacovigilance representative/safety scientist General Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and international drug safety regulations Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Maintaining excellent knowledge of the safety profile of assigned products Communicating and discussing issues related to review process with Project Manager Interacting with internal and external contacts for resolving issues Maintaining a good working knowledge of relevant regulatory guidelines Attend and present client/cross functional meetings along with other stakeholders Case report Medical review Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality Assessing seriousness and expectedness of reported events Providing medical advice to case processing team Skills Excellent interpersonal, verbal and written communication skills Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system Client focused approach to work A flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential Willingness to work in a matrix environment and to value the importance of teamwork Strong knowledge of international drug regulation including GCP, GVP Knowledge And Experience Good knowledge of medical terminology. Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred. Education MBBS/MD Show more Show less

Key Responsibilities Deliver training sessions on Clinical Research, GCP (Good Clinical Practice), Regulatory Affairs, Pharmacovigilance, and related topics Design, update, and improve training materials, presentations, and assessments Assess and evaluate trainees' understanding through tests, assignments, and practical exercises Stay updated with the latest industry trends, guidelines, and regulatory changes Conduct both classroom and online training sessions as per company requirements Provide career guidance and mentoring to students/professionals Collaborate with industry experts to enhance training effectiveness Requirements Minimum 1 year of experience in clinical research / clinical trials / Pharmacovigilance or a related field Strong knowledge of ICH-GCP, CDSCO, USFDA, EMA, and other global regulatory guidelines Excellent communication and presentation skills Experience in training, mentoring, or teaching is an advantage Ability to engage and interact effectively with learners Proficiency in using LMS (Learning Management Systems) and online training platforms is a plus About Company: PMCTI stands for Pune Medical Coding Training Institute. We are a leading provider of medical coding training in Pune, India, dedicated to empowering individuals with the knowledge and skills necessary to thrive in this dynamic and rewarding healthcare field. Our team is comprised of passionate and experienced professionals who share a deep commitment to education and excellence. We boast certified trainers with extensive industry experience, who are equipped to guide and mentor aspiring medical coders. We believe in fostering a supportive and collaborative learning environment where students can acquire valuable knowledge, build confidence, and achieve their career goals. Show more Show less

Job Overview Provide leadership for Lifecycle Safety, Service Operations (SO), developing cross-functional integrated delivery plans for safety operations throughout all stages of the Lifecycle Safety opportunity chain. Provide leadership for a combination of designated Lifecycle safety operations service lines and direction for specified accounts. Participate actively in local and global initiatives, as needed. Provide line management for assigned staff who are deployed in Service Operations. Primary point of contact for assigned customers or account Essential Functions Accountable to monitor and track project financials/ budget to ensure agreed margins are maintained Independently engage assigned customers on escalation, scope expansion and look for additional business opportunities Lead a high quality and efficient Service Operations team. Develop and review the team reporting structure for IQVIA while adhering to governing standard operating procedures (SOPs), work instructions and applicable regulatory guidelines and regulations. Accountable to meet all project specific SLA and KPI’s Direct and support operational decisions in collaboration with senior management. Ensures financial project performance through oversight of key performance metrics. (revenue, direct costs, time-sheet costs, utilization and realization). Act as mentor and coach to less experienced managers, as appropriate. Lead and support ongoing overarching operational, strategic and tactical initiatives as assigned/ agreed, ensuring timely and complete delivery. Direct project resource assignments including staff hiring, and training in collaborations with senior management. Direct and/or participate in cross-functional teams and other process improvement initiatives. Lead and anticipate actively in local and global initiatives, as needed. Support in designing functional strategy Demonstrate and cascade the organizational vision and mission, core values Ability to independently participate in Request for proposal (RFP) and bid defense Ability to represent IQVIA in various industry forums and conference as required Qualifications Bachelor's Degree Scientific or healthcare discipline or allied life sciences Bachelor’s degree in health science or related area, and 15 years experience in Contract Research Organization or Pharmaceutical company or life science services company, including 10 years of experience in managing a workforce of up to 400+ employees, operating with senior/executive management teams or equivalent combination of education, training and experience. Ability to clearly articulate to large group and build consensus. Ability to address large audience during townhalls and other external forums. Excellent interpersonal skills, effective communication. Engagement with global delivery hubs. In-depth knowledge of Safety service lines. willingness to increase knowledge across Safety service lines and develop new skills. Proven Staff management skills, strong leadership, motivational and influencing skills. Ability to work on multiple projects and manage competing priorities. Effective mentoring and developed coaching skills. Excellent presentation, report writing skills and customer focus skills. Ability to achieve results through communication and facilitation in a matrix service delivery environment with shared accountabilities. Sound judgment, decision-making and problem solving skills. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Ability to support in drafting SOP, Operation, Technical Project documents. Ability to understand and analyze performance Metrix and numbers to support operations. End to End Project management exposure. Excellent team leadership and customer services skills. strategic customer focus. Strategic understanding of business processes across opportunity chain and all phases of product lifecycle. Strong analytical, judgment and decision-making skills. Strong innovation/solution skills. Strong communication (written and verbal) and presentation skills. Strong problem-solving, influencing, negotiation, conflict management and collaboration skills. Highly effective time management and delegation skills, ability to manage multiple competing priorities, meet multiple demanding timelines and work creatively in fast-paced environment. Strong ability to deliver results to the appropriate productivity, budgetary and quality metrics. Demonstrated flexibility, initiative, proactivity, ownership and accountability. In depth knowledge of and ability to apply GCP/ICH/Good Pharmacovigilance Practice and applicable regulatory guidelines. Strong ability to establish and maintain effective working relationships with coworkers, managers and customers. - Extensive use of keyboard requiring repetitive motion of fingers. Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Regular sitting for extended periods of time. May require occasional travel. Flexibility to operate in shifts. Flexibility to support in global time zones as required. 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 Show more Show less

Job Summary The TM-Pharmacovigilance role involves ensuring the safety and efficacy of pharmaceutical products through vigilant monitoring and analysis. With a focus on regulatory intelligence the candidate will contribute to maintaining compliance and enhancing customer service. This hybrid role requires rotational shifts and proficiency in English with no travel obligations. Responsibilities Monitor and analyze adverse drug reactions to ensure patient safety and product efficacy. Collaborate with cross-functional teams to gather and interpret regulatory intelligence data. Provide expert guidance on pharmacovigilance processes to enhance customer service experiences. Develop and implement strategies for effective risk management and mitigation. Ensure compliance with global regulatory standards and guidelines in pharmacovigilance activities. Oversee the preparation and submission of regulatory reports and documentation. Conduct thorough research to support the development of new pharmacovigilance methodologies. Facilitate communication between stakeholders to ensure seamless regulatory affairs processes. Utilize advanced analytical tools to assess and improve pharmacovigilance systems. Lead initiatives to optimize research and development efforts in drug safety. Support the integration of regulatory intelligence into strategic planning and decision-making. Drive continuous improvement in pharmacovigilance practices to benefit public health. Maintain up-to-date knowledge of industry trends and regulatory changes. Qualifications Possess strong expertise in customer service within the pharmacovigilance domain. Demonstrate proficiency in regulatory intelligence and its application in drug safety. Have experience in regulatory affairs and research and development as a nice to have skill. Exhibit excellent communication skills in English both written and spoken. Show ability to work effectively in a hybrid work model with rotational shifts. Display a commitment to maintaining high standards of compliance and safety. Bring a proactive approach to problem-solving and process improvement. Certifications Required Certified Pharmacovigilance Professional Regulatory Affairs Certification - B.Pharm/M.Pharm

Job Summary The TM-Pharmacovigilance role involves ensuring the safety and efficacy of pharmaceutical products through vigilant monitoring and analysis. With a focus on regulatory intelligence the candidate will contribute to maintaining compliance and enhancing customer service. This hybrid role requires rotational shifts and proficiency in English with no travel obligations. Responsibilities Monitor and analyze adverse drug reactions to ensure patient safety and product efficacy. Collaborate with cross-functional teams to gather and interpret regulatory intelligence data. Provide expert guidance on pharmacovigilance processes to enhance customer service experiences. Develop and implement strategies for effective risk management and mitigation. Ensure compliance with global regulatory standards and guidelines in pharmacovigilance activities. Oversee the preparation and submission of regulatory reports and documentation. Conduct thorough research to support the development of new pharmacovigilance methodologies. Facilitate communication between stakeholders to ensure seamless regulatory affairs processes. Utilize advanced analytical tools to assess and improve pharmacovigilance systems. Lead initiatives to optimize research and development efforts in drug safety. Support the integration of regulatory intelligence into strategic planning and decision-making. Drive continuous improvement in pharmacovigilance practices to benefit public health. Maintain up-to-date knowledge of industry trends and regulatory changes. Qualifications Possess strong expertise in customer service within the pharmacovigilance domain. Demonstrate proficiency in regulatory intelligence and its application in drug safety. Have experience in regulatory affairs and research and development as a nice to have skill. Exhibit excellent communication skills in English both written and spoken. Show ability to work effectively in a hybrid work model with rotational shifts. Display a commitment to maintaining high standards of compliance and safety. Bring a proactive approach to problem-solving and process improvement. Certifications Required Certified Pharmacovigilance Professional Regulatory Affairs Certification - B.Pharm/M.Pharm Show more Show less

Skill required: Pharmacovigilance Services - Safety Writing Designation: Pharmacovigilance Services Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 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 Prepare and review PSUR/ PBRER/DSUR/PADER/ Addendum Statement/Addendum to clinical overview/US IND reports/ Aggregate finding safety reports/Local reports/ Cumulative Review/Health Authority requests / Health Authority assessment reports as per the applicable procedural documents on the project.Perform scheduling of reports, and author, peer review, publishing, tracking and management activities of assigned reports.Perform request for inputs activity for the reports (based on the RFI [request for information] and as per the applicable process and SOPs).Send the case closure request and request for Line Listings/ Summary Tabulations, as applicable.Initiate, organize, and lead the strategy meeting for evaluation of safety topic/request. Prepare meeting minutes and distribute final minutes with all invitees.Review the information received from contributors and obtain any missing information.Draft aggregate report using clients templates including analysis of safety, clinical and other global line function data. Summarize literature information for applicable reports.Perform peer review of the draft report.Share the draft for quality review.Address the comments from the peer reviewer, quality reviewer and incorporated into the report.Share the draft report with client (or external) stakeholders for review (as applicable).Incorporate and address the comments from stakeholders into the draft report and seek clarification where applicable.Schedule meetings with project safety physicians to resolve report related queries and prepare submission ready draft report.Perform final peer review of draft reports and provide feedback with the duly filled defect tracker.Share the final draft along with the QC scorecard results to client (as applicable).Obtain Client/ESP signature/approvals for the finalized report.Complete and finalize report according to the procedural document requirements.Ensure compliance of finalized report with applicable process and SOPs.Obtain signature/approval for the finalized reports as defined in procedural document What are we looking for Ability to establish strong client relationship Roles and Responsibilities: Prepare/compile the final report and confirm that document is complete, including it contains all the applicable annexes as needed and instructed by client, and then submit the finalized report to client.Notify client (regulatory team) that the final report has been submitted to client and confirm all prepared submission documents are uploaded into client environment.Archive AR-related information in dedicated folders on client shared drives or other electronic repositories (as agreed in the procedural document).Perform HA submission tracking of applicable Aggregate ReportsCapture quality data for metrics reporting.Responsible for knowledge sharing, coaching, review and providing feedback of reports processed by the Mentees.Complete all trainings assigned by internal and client on their LMS within due date.Notify critical and major deviations (referred as Quality Issues) within one business days and minor deviations- three business days to Accenture Quality Management team.Organize, action, and archive the communication received at and sent from AR mailbox appropriately.Share/forward product/document type relevant emails to the appropriate user/owner as required and ensure closure.Management of Accenture personal assigned to the AR function.Oversight on the AR mailbox managementEnsure teams delivery of reports within agreed timelines with SLAs and KPIs.Liaising with client or any issue mitigation and troubleshooting.Ensure the retention.Ensure training and mentoring of new associates and documentation of the same.Address any quality related issues and implementation of quality improvement initiatives for the team. Qualification Bachelor of Pharmacy

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Affiliate Team AssociateAffiliate Team Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: BSc/Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English(International) - Proficient About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. 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 BSc,Bachelor of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years Language - Ability: English(International) - Advanced 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 Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. What are we looking for Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 5 to 8 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Ability to establish strong client relationshipAbility to work well in a teamCollaboration and interpersonal skills Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy

Watson Pharma Private Limited. is looking for Medical Writing Associate to join our dynamic team and embark on a rewarding career journey Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Preparation of operating budgets, financial statements, and reports. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processe

Skill required: Operations Support - Pharmacy Benefits Management (PBM) Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Language - Ability: English(International) - Intermediate About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Claims team which is responsible for the administration of health claims. This team is involved in core claim processing such as registering claims, editing & verification, claims evaluation, and examination & litigation.The business processes, operations and interactions of third party administrators of prescription drug programs, understanding of the processes used to manage programs for payers, process and pay prescription drug claims, develop and maintain the formulary, contract with pharmacies and negotiate discounts and rebates with drug manufacturers. What are we looking for Ability to perform under pressureAdaptable and flexibleAbility to establish strong client relationshipWritten and verbal communicationPrioritization of workload 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 Any Graduation

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Ability to meet deadlinesAbility to perform under pressureAbility to work well in a teamAdaptable and flexibleAgility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Associate Qualifications: BE/BTech/BCA Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be part of our Life Sciences R&D division, which offers a comprehensive range of services across the life sciences sector. This includes Clinical Data Management, regulatory services, pharmacovigilance, and patient services solutions. Employees within this clinical capability will join one of our sub-offerings, such as Clinical Database build and Clinical Reporting. In these roles, you will support leading biopharma companies in realizing their vision, enhancing outcomes by focusing on the patient and integrating scientific expertise with unique insights into the patient experience.The Clinical Reports Programming team is dedicated to developing and maintaining clinical reports for clinical trials. This involves utilizing PL/SQL, SQL, and Clinical SAS programming skills to create these reports. The team also integrates data from various sources such as EDC, Labs, and IRT. Ensuring that all reports comply with regulatory standards and guidelines is a crucial part of their work. They implement stringent quality assurance processes to uphold the highest levels of data integrity and report accuracy. Additionally, the team collaborates closely with clinical operations, biostatistics, and other departments to ensure the reports meet the needs of all stakeholders, facilitating informed decision-making based on accurate and timely data.Develop and review complex reports, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for Oracle Procedural Language Extensions to SQL (PLSQL)Structured Query Language (SQL)Experience in writing programs using Clinical SASClinical Database ProgrammingClinical Data ManagementSAS ClinicalAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BE,BTech,BCA

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: BCom/MCom/Master of Business Administration Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for Adaptable and flexibleAbility to perform under pressureAgility for quick learningAbility to work well in a teamCommitment to quality Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BCom,MCom,Master of Business Administration

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Specialist Qualifications: BE Years of Experience: 7 to 11 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.Develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for Generative AI, LLM (Large Language Model), Python skills along with OOPS concept. Understands framework and have understanding on agentic AI building. Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification BE

Job Overview Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members. Essential Functions To Prioritize and complete the assigned trainings on time. 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 as per internal/ project timelines. Ensure to meet quality standards per project requirements. Ensure to meet productivity and delivery standards per project requirements. To ensure compliance to all project related processes and activities. Creating, maintaining and tracking cases as applicable to the project plan. Identify quality problems, if any, and bring them to the attention of a senior team member. To demonstrate problem solving capabilities. To mentor new teams members, if assigned by the Manager. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. 100% compliance towards all people practices and processes Perform other duties as assigned. Qualifications High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req An Individual with a minimum of a Bachelor s Degree in scientific or healthcare discipline or allied life sciences graduation with 1-1.5 years of relevant experience. Req Good knowledge of medical terminology. Intermediate Working knowledge of applicable Safety Database. Beginner Knowledge of applicable global, regional, local clinical research regulatory requirements. Beginner Excellent attention to detail and accuracy. Beginner Good working knowledge of Microsoft Office and web-based applications. Beginner Strong organizational skills and time management skills. Beginner Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Ability to multi-task, manage competing priorities and deadlines. Beginner Ability to delegate to less experienced team members. Beginner Willingness and aptitude to learn new skills across Safety service lines. Beginner Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Beginner Ability to work as a Team Player, contribute and work towards achieving Team goals. Beginner Ensure quality of deliverables according to the agreed terms. Beginner Demonstration of IQVIA core values while doing daily tasks Beginner Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Beginner Regular sitting for extended periods of time. Beginner May require occasional travel. Beginner Flexibility to operate in shifts. Beginner