1759 Pharmacovigilance Jobs - Page 41

We are looking for a Life Science Senior Content Specialist to join our team in Hyderabad/Noida. This is an amazing opportunity to work on OFF-X, a translational drug safety intelligence portal. The team consists of 20 people located in Spain and India and is reporting to the India-based Team Manager. We have a great skill set in the analysis of drug safety and toxicity data and we would love to speak with you if you have skills in that area About You – Experience, Education, Skills, And Accomplishments Degree in Life Sciences (Pharmacy, Pharmacology, Toxicology, Biology, Biomedical Sciences, etc.) Min 5 years of experience in drug safety, toxicology, pharmacovigilance Excellent English written and oral communication skills Attention to detail, results orientated, enthusiastic, determined to achieve and shows commitment It would be great if you also had . . . Ability to analyze large volumes of structured or unstructured data. Ability to delve deep into content and results. Interpersonal skills and the ability to work independently and collaboratively with a team Self-starter with the ability to multitask and prioritize across projects to meet deadlines Good skills of problem-solving and good judgment in decision-making and setting priorities. What will you be doing in this role? Selection of appropriate scientific articles and conference content for the project. Analysis and interpretation of published data (clinical trials, journal articles, reviews, meta-analysis, congress communications, drug approval reports, etc.) Collection and curation of information on risks and safety of drug products (recording, archiving, updating and evaluating the information) Writing case studies, reports and reviews Maintain informed discussions with experts and customers About The Team Our editorial team is a group of 20 people creating and delivering content for OFF-X, a translational drug safety intelligence portal that allows user to easily identify new safety liabilities. We are a global team based on India and Spain with more than 50 years of experience in the sector. We create and classify content for more than 300 references every week, including Journals, Congress publications and Regulatory documents. In this team you will have the opportunity to be up-to-date with all the new advances in the drug development industry and you will be constantly learning new things. Location - Hyderabad / Noida At Clarivate, we are committed to providing equal employment opportunities for all qualified persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations. Show more Show less

Description Safety & PV Specialist I-Japanese -Pune Office Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications, and tests. Compiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. Maintains safety tracking for assigned activities. Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required. Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA. Manual recoding of un-recoded product and substance terms arises from ICSRs. Identification and management of duplicate ICSRs. Activities related to SPOR / IDMP. Quality review of ICSRs. Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process. Fosters constructive and professional working relationships with all project team members, internal and external. Participates in audits as required/appropriate. Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities. Qualifications Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS/MD Years of Experience: 3 to 5 years Language - Ability: English(International) - Proficient About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.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 world’s 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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? Performs Medical Assessment activities related to drug safety Pharmacovigilance for the Individual Case Safety Reports - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals - Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP - Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables - Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable - Performs labelling of events of applicable cases - Provides Medical Expertise to case processing team whenever required - Provides training/mentoring to the team members wherever applicable 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? Understanding of Pharmacovigialnce Experience in Medical Review of ICSRs Medical Review Roles and Responsibilities: - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals - Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP - Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables - Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable - Performs labelling of events of applicable cases - Provides Medical Expertise to case processing team whenever required - Provides training/mentoring to the team members wherever applicable Show more Show less

The Clinical Trial Physician is responsible for providing medical input within the organization as well as to external partners and performing medical review tasks within the context of clinical trials. Furthermore, the Clinical Trial Physician is responsible for undertaking scientific/medical writing tasks within the organization. Role & responsibilities Is responsible for the development of: All study related documents that fall under the Clinical Science Department scope (e.g., Study Protocols, ICFs - in collaboration with other departments e.g., Clinical Operations, Regulatory, as required -, Pharmacy Manuals, Medical Review Plans, etc.), Scientific presentations and manuscripts, Medical training material (i.e. therapeutic area and study protocol training material) Delivers internal and external study protocol and therapeutic area training courses Provides medical expertise and consultation within the Company on key therapeutic areas of the clinical development program Provides guidance to all involved departments on the medical and scientific aspects of the assigned clinical trials/projects. Responds to medical queries from all involved parties in assigned clinical trials (e.g., CRAs, Project Managers, Clinical Operations Managers, Investigators) and collaborates with all concerned staff in maintaining an up-to-date study-specific Q&A log Is available 24/7 to respond to urgent medical/protocol related issues derived from an Investigational Site, as applicable Performs periodic medical review of the data from clinical trials according to the study-specific Medical Review Plan requirements (e.g., review of eligibility, review of efficacy and safety data). Performs real-time medical review on urgent medical and safety issues, as needed Collaborates with and provides medical input to the Data Management staff to ensure the successful development of the study-specific eCRF Attends Investigator Meetings and Conferences, as applicable Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection and ICH GCP requirements Preferred candidate profile Required Medical Degree (MBBS, MD) Preferred: Clinical experience in the therapeutic area of the assigned study or of the Companys clinical development program - Preferred: 2 years of experience in a CRO or in the pharma industry in a relevant role (Clinical, Medical Information, Medical Affairs or PV) Key competencies Exceptional written and oral use of English In-depth knowledge of medical and drug terminology Good medical judgement and ability to make medical decisions Excellent communication skills Excellent business acumen Initiative taking and team working attitude Excellent Organizational skills Innovative thinking Excellent IT skills Deep understanding of the Clinical Development industry

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS/MD Years of Experience: 3 to 5 years Language - Ability: English(International) - Proficient About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.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 world’s 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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? Performs Medical Assessment activities related to drug safety Pharmacovigilance for the Individual Case Safety Reports - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals - Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP - Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables - Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable - Performs labelling of events of applicable cases - Provides Medical Expertise to case processing team whenever required - Provides training/mentoring to the team members wherever applicable 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? Understanding of Pharmacovigialnce Experience in Medical Review of ICSRs Medical Review Roles and Responsibilities: - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals - Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP - Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables - Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable - Performs labelling of events of applicable cases - Provides Medical Expertise to case processing team whenever required - Provides training/mentoring to the team members wherever applicable MBBS,MD Show more Show less

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 3 to 5 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.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 world’s 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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.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 world’s 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. You will be expected to coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for? Commitment to quality Agility for quick learning Adaptable and flexible Ability to work well in a team Ability 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 Bachelor of Pharmacy Show more Show less

Job Description Technical Support Engineer - Python About ArisGlobal ( www.arisglobal.com ): ArisGlobal is empowering life science organizations to deliver breakthroughs faster , accurately , and with precision. This is paramount for the passage of lifesaving medications and products VIA clinical trials, using our software and technology. As an industry leader, ArisGlobal provides our SaaS leading technology and services to 40/50 top Bio-pharmaceutical corporations, 4/5 of the most advanced global pharmaceutical companies and nine government-health authorities, including the FDA, Health Canada and the NMPA, for example, around the world. 2021 has presented simultaneous developments in the global Drug Safety and Pharmacovigilance Software Market, projecting unfaltering growth through 2027. Effectively harnessed by prominent market drivers, ArisGlobal is named a Key Player. Located in Miami, New Jersey, Budapest, Dublin, Darmstadt, Rome, Tokyo, Shanghai, Bangalore, Mysore, our global presence is clear, and we are growing faster than ever . Requirements: Bachelor s degree in computer science, Information Technology. 2-6 years of experience in Technical Support/Application Support and IT service management, preferably in a global organization. Minimum 1+ Years of strong experience in Python (Mandatory) Good SQL (OR) PL/SQL skills To fetch case data based on customer requirements. To write update statements on scenario basis for case correction. Should be ready work in 24X7 shift based support team Strong knowledge of IT service management frameworks (ITIL) and best practices. Proven track record in driving support excellence and customer satisfaction. Experience in managing customer service level agreements. Excellent analytical, problem-solving, and decision-making skills. Strong leadership and interpersonal skills, with the ability to collaborate effectively across teams and influence stakeholders. Collaborative mindset and the ability to work seamlessly within diverse teams and drive concept implementation. Exceptional communication and presentation skills, both written and verbal. Working knowledge with ticketing tools like Jira, ZenDesk, ServiceNow. Roles & Responsibilities: As Tier-2 engineer for you would be responsible for providing application functionality support and technical support for ArisGlobal Life Sphere applications, associated interfaces or any other product of ArisGlobal. Take ownership of tickets logged by customer and delivery excellent customer experience that meets ArisGlobal organizational values Collaborate with cross-functional teams and support Service Delivery managers to establish service delivery standards and best practices, ensuring alignment with business objectives. Monitor and analyse service performance using industry-leading methodologies, identify areas for improvement, and implement corrective actions. Lead/Collaborate in service improvement initiatives, leveraging continuous improvement methodologies and frameworks. Oversee incident and problem management processes, ensuring timely resolution and minimizing impact on operations. Foster a culture of customer-centricity within the organization, promoting a high level of customer service and engagement. Good To have skills: Good understanding of Pharmacovigilance Added advantage if you possess the below listed experience or similar enterprise products experience. Working knowledge with case processing life cycle from case creation to distribution.

Job Description Technical Support Engineer About ArisGlobal ( www.arisglobal.com ): ArisGlobal is empowering life science organizations to deliver breakthroughs faster , accurately , and with precision. This is paramount for the passage of lifesaving medications and products VIA clinical trials, using our software and technology. As an industry leader, ArisGlobal provides our SaaS leading technology and services to 40/50 top Bio-pharmaceutical corporations, 4/5 of the most advanced global pharmaceutical companies and nine government-health authorities, including the FDA, Health Canada and the NMPA, for example, around the world. 2021 has presented simultaneous developments in the global Drug Safety and Pharmacovigilance Software Market, projecting unfaltering growth through 2027. Effectively harnessed by prominent market drivers, ArisGlobal is named a Key Player. Located in Miami, New Jersey, Budapest, Dublin, Darmstadt, Rome, Tokyo, Shanghai, Bangalore, Mysore, our global presence is clear, and we are growing faster than ever . Requirements: Bachelor s degree in computer science, Information Technology. 2-4 years of experience in Technical Support/Application Support and IT service management, preferably in a global organization. Good SQL (OR) PL/SQL skills To fetch case data based on customer requirements. To write update statements on scenario basis for case correction. Should be ready work in 24X7 shift based support team Strong knowledge of IT service management frameworks (ITIL) and best practices. Proven track record in driving support excellence and customer satisfaction. Experience in managing customer service level agreements. Excellent analytical, problem-solving, and decision-making skills. Strong leadership and interpersonal skills, with the ability to collaborate effectively across teams and influence stakeholders. Collaborative mindset and the ability to work seamlessly within diverse teams and drive concept implementation. Exceptional communication and presentation skills, both written and verbal. Working knowledge with ticketing tools like Jira, ZenDesk, ServiceNow. Roles & Responsibilities: As Tier-2 engineer for you would be responsible for providing application functionality support and technical support for ArisGlobal Life Sphere applications, associated interfaces or any other product of ArisGlobal. Take ownership of tickets logged by customer and delivery excellent customer experience that meets ArisGlobal organizational values Collaborate with cross-functional teams and support Service Delivery managers to establish service delivery standards and best practices, ensuring alignment with business objectives. Monitor and analyse service performance using industry-leading methodologies, identify areas for improvement, and implement corrective actions. Lead/Collaborate in service improvement initiatives, leveraging continuous improvement methodologies and frameworks. Oversee incident and problem management processes, ensuring timely resolution and minimizing impact on operations. Foster a culture of customer-centricity within the organization, promoting a high level of customer service and engagement. Good To have skills: Good understanding of Pharmacovigilance Added advantage if you possess the below listed experience or similar enterprise products experience. Working knowledge with case processing life cycle from case creation to distribution.

Work Schedule Second Shift (Afternoons) Environmental Conditions Office Job Description Purpose: Subject matter expert of day-to-day application configuration and maintenance activities of the Pharmacovigilance (PV) Safety database Oracle Argus, ensuring that performed tasks comply with SOPs and policies, industry standards, and applicable regulations. Provides technical solutions, support systems implementation and testing following change control procedures and provide systems administration to support the requirements and initiatives of the PV Safety group. Responsibilities include but are not limited to: Collaborates with PV business users to understand the requirements and recommend solutions. Creates custom and ad-hoc reports from the PV Safety database using built in tools, OBIEE, or SQL. Develops and validates aggregate safety reports. Assists with internal and external audits of the PV Safety database. Interacts with project team or client and seeks feedback on deliverables. Provides programming support to project teams and clients for safety data review, ad-hoc reports and other activities. Leads project initiatives as needed, ensures desired outcome is achieved on time and in scope. Reviews and makes recommendations for process development and improvement. Manages assignment to meet timelines and deliver high quality work. Estimates effort to assist in bidding activities or cost construction. Qualifications: Education and Experience: Bachelors degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) Knowledge, Skills and Abilities: System administration experience in Oracle Argus including current knowledge of safety system configuration, database structure, mappings requirements and transformation rules Strong experience generating reports Strong SQL programming skills Knowledge of relational data base structure and experience working with complex data systems Proficient of one or more programming languages Strong attention to detail Problem solving skills Good written and verbal communications skills Ability to independently and effectively organize and manage multiple assignments with challenging timelines Ability to adapt and adjust to changing priorities Demonstrated leadership, initiative and motivation Ability to mentor and direct the work of junior staff Ability to communicates effectively within a multi-disciplinary team Ability to complete assigned tasks on time and within budget

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 Bachelors 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 Let s stay connected. Sign up to receive alerts when new opportunities become available that match your career ambitions.

This role is responsible for creating and validating ad hoc reports and queries needed to support Pharmacovigilance and signal detection activities as well and the review of these reports and queries to verify that they are accurate and consistent with the request from the subject matter expert This role encompasses many of the operational aspects within the System Support and Data Management unit. This role works directly with all GPV stakeholders, including GSOs, PV Scientists, to accurately interpret and translate business needs into the appropriate technical language to ensure that configuration, operations, validation, and/or analytic reporting deliverables meet business needs. This role is responsible for the oversight and management of various aspects of the safety database system as well as direct involvement and oversight of projects designed to deliver enhancements, change controls and future tools to support GPE. Additionally, the role will have oversight for multiple vendor activities supporting the SSDM team. The incumbent works with all Safety System and Data Management stakeholders to ensure accurate planning and execution of critical database system activities The role can also participate in the configuration of the safety database as well as the development, validation and maintenance of the system enhancements including the generation and approval of documentation to support the customer methodology PUMA (Project Unified Methodology Approach). It is important that the role has a strong PV knowledge and working relationships with the user community as well as the Information Technology (ITS) department. . 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

This role is responsible for creating and validating ad hoc reports and queries needed to support Pharmacovigilance and signal detection activities as well and the review of these reports and queries to verify that they are accurate and consistent with the request from the subject matter expert This role encompasses many of the operational aspects within the System Support and Data Management unit. This role works directly with all GPV stakeholders, including GSOs, PV Scientists, to accurately interpret and translate business needs into the appropriate technical language to ensure that configuration, operations, validation, and/or analytic reporting deliverables meet business needs. This role is responsible for the oversight and management of various aspects of the safety database system as well as direct involvement and oversight of projects designed to deliver enhancements, change controls and future tools to support GPE. Additionally, the role will have oversight for multiple vendor activities supporting the SSDM team. The incumbent works with all Safety System and Data Management stakeholders to ensure accurate planning and execution of critical database system activities The role can also participate in the configuration of the safety database as well as the development, validation and maintenance of the system enhancements including the generation and approval of documentation to support the customer methodology PUMA (Project Unified Methodology Approach). It is important that the role has a strong PV knowledge and working relationships with the user community as well as the Information Technology (ITS) department.

Description Medical Writer I Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Compiles, writes, and edits medical writing deliverables, and serves as medical writer within and across departments with moderate supervision. Develops or supports, a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinicalstudy reports; o Patient narratives; o Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency. Provides feedback to further define statistical output required. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. Performs on-line clinical literature searches, as applicable. Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills. Is aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. Completes required administrated tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications 1. Any Life Science postgraduate-Prefer M.Pharm,PharmD 2. Candidates having experience in Clinical Trial Disclosure, Regulatory Medical Writing, Pharmacovigilance (Safety Narrative Writing). 3. Responsibilities include drafting CTD documents for clients and performing quality checks (QC) documents 4. Preferred experience with results posting for regulatory bodies such as US FDA, ClinicalTrials.gov (ct.gov), EUCTR 0. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

PLEASE NOTE - THIS IS A HEALTHCARE MARKET RESEARCH ROLE (NOT AN IT OR A SOFTWARE DEVELOPMENT ROLE) Konovo is a global healthcare intelligence company on a mission to transform research through technology- enabling faster, better, connected insights. Konovo provides healthcare organisations with access to over —the largest network of its kind globally. With a workforce of over 200 employees across 5 countries: India, Bosnia and Herzegovina, the United Kingdom, Mexico, , we collaborate to support some of the most prominent names in healthcare. Our customers include over 300 global pharmaceutical companies, medical device manufacturers, research agencies, and consultancy firms. As we transition from a service-oriented model to a product-driven platform, we are expanding our hybrid Bengaluru based team. We are looking for a Data Quality Analyst, Compliance to contribute to our mission by by ensuring the highest standards of data quality and compliance for global research studies, monitoring patient safety events, conducting thorough data reviews, and collaborating with Client Services and Compliance teams to meet client requirements. Your role will directly impact patient safety and data accuracy, supporting the timely reporting of safety events and the organisation's training programs. How You'll Make an Impact: Partner closely with the Client Services team to proactively monitor both domestic and global research studies, ensuring data integrity and adherence to quality standards. Collaborate with the Compliance team to swiftly identify and escalate adverse events, product complaints, and other special situations involving client products, particularly those impacting patient safety. Ensure accurate and timely submission of patient safety events and reconciliation reports, in strict alignment with client pharmacovigilance requirements and regulatory expectations. Act as a Quality Analyst, specializing in patient safety and data quality oversight across a high volume of survey data. Conduct thorough daily reviews to validate data accuracy, enforce compliance protocols, and deliver actionable insights to the Client Services and Compliance teams. Maintain accountability for timely and accurate reporting of safety-related findings to client pharmacovigilance departments. Contribute to the success of the organization's Patient Safety Reporting Training Program by supporting its execution and ongoing development. Execute responsibilities that consistently require sound judgment, independent decision-making, and a high level of discretion in a fast-paced, data-driven environment. What We're Looking For: 1+ years of experience in Data Quality Control, preferably within the Healthcare Market Research industry Demonstrated commitment to excellence, with the ability to adapt quickly to evolving needs. Exceptional analytical capabilities, coupled with outstanding written and verbal communication skills, including strong comprehension and articulation. Fluent (speaking, reading, writing) in English Strong communication skills, both written and verbal, and the ability to work in cross-functional teams. Proven ability to multitask, prioritize effectively, and navigate ambiguity with confidence. Meticulous attention to detail, with strong record-keeping and document management skills. Highly self-motivated and capable of working independently with minimal supervision. Willingness to maintain a flexible schedule to meet project timelines, including coverage during U.S. Eastern Time Zone hours (9:00 AM to 5:00 PM EST) and occasional weekend shifts as part of a rotating schedule. High attention to detail and proven ability to work in a fast-paced environment. Proficiency in Microsoft Office Suite Why Join Konovo? Be part of a mission-driven organisation that is empowering life science researchers and data scientists with the broadest ecosystem of healthcare audiences and an intelligent, AI-enabled platform — so insights aren't just collected, they're connected. Join a fast-growing global team with opportunities for professional growth and advancement. Enjoy a collaborative and hybrid work environment that fosters innovation and flexibility. Experience a workplace that puts employees first, offering a workplace designed for growth, well-being, and balance. Become a part of an organisation that prioritizes your well-being with comprehensive benefits, including group medical coverage, accident insurance, and a robust leave policy. Our employee-centric policies ensure a rewarding and fulfilling work experience. Make a real-world impact by helping healthcare organisations innovate faster. This is just the beginning of what we can accomplish together. Join us at Konovo and help shape the future of healthcare technology! Apply now to be part of our journey. Show more Show less

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission. Job Title - Medical Reviewer Location: Gurgaon Summary: The Medical Reviewer (MR) is responsible for: Provide medical review for individual case safety reports, including: coding, seriousness, expectedness, Baxter causality assessment. Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment. Potential review of periodic documents, and product labels. Essential Duties and Responsibilities: Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment. Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities. Support the Safety Operations team, providing expertise for the case processing team for medical questions e.g., coding of events, understanding coding conventions, splitting of cases etc. Maintain knowledge of global regulatory authority regulations (especially FDA and EMA). Contribute to the training, leadership and continuing education for all departmental staff. May perform benefit-risk safety analysis, including: safety surveillance activities for potential safety signals, aggregate safety data review, risk management plans and REMS, Regulatory Authority assessment reports and queries, and periodic documents, such as PSURs, PBRERs, and PADERs. Qualifications: Knowledge of industry regulations and drug safety practices globally. Knowledge of adverse event case report triage processing. Experience with commercial databases and safety coding dictionaries (MedDRA, WHOART, COSTART, etc.). Excellent oral and written communication skills. Excellent teamwork and interpersonal skills are required. Strong skills in presenting drug safety topics for regulatory authorities or at conventions, meetings, etc. Education and/or Experience: A medical degree (or equivalent) and board certification/eligibility are required. Two years of experience post-residency, with at least one year of experience in pharmaceutical/biotechnology company. Exposure to working relationship with FDA, EMA, or other regulatory authorities is preferred. Knowledge and understanding of national and international regulatory guidelines are a plus. Knowledge of medical aspects of drug safety in pre- and post-marketing safety practice. At Baxter, we offer a dynamic and future focused work environment offering workplace flexibility, additional annual leave and a strong value driven culture. Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. EEO (Equal Employment Opportunity) Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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 #LI-REMOTE

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 #LI-REMOTE

Summary In this role you will lead an impactful deliverable across the pharma value chain from drug discovery to commercialization by leveraging Indepth understanding in business process and Generative AI About The Role Major accountabilities: Domain Expertise: Possess a knowledge across the end-to-end pharmaceutical value chain, including drug discovery, preclinical and clinical trials, regulatory affairs, pharmacovigilance, technical operations (manufacturing, supply chain, and quality assurance), and commercial operations (market access, sales, and marketing), to lead AI-driven initiatives. Stay updated on advancements in Generative AI and their applications to optimize processes across the pharmaceutical value chain, from R&D to commercialization. Business Analysis: Partner with senior stakeholders across R&D, manufacturing, and commercial teams to gather, document, and analyse complex business requirements, ensuring alignment with strategic organizational goals. Conduct in-depth analyses of business processes across the E2E value chain, identifying opportunities for Generative AI to enhance efficiency, quality, and market competitiveness. Develop detailed business cases, feasibility studies, and cost-benefit analyses to prioritize AI initiatives in drug development, manufacturing optimization, and commercial strategies. Create comprehensive business requirements documents, process flow diagrams, and solution blueprints to guide AI implementation across the value chain. Stakeholder Engagement: Translate complex AI concepts into actionable insights for technical and non-technical stakeholders in R&D, technical operations, and commercial teams, securing buy-in and alignment. Facilitate workshops, strategy sessions, and cross-functional meetings to drive consensus on AI projects spanning discovery to commercialization. Mentor junior analysts to build team capability in AI-driven business analysis within the pharmaceutical value chain. Generative AI: Leverage Generative AI to analyse large, complex datasets across the value chain, uncovering patterns, trends, and insights for applications like drug candidate identification, manufacturing process optimization, and market demand forecasting. Collaborate with data scientists and AI engineers to design, develop, and deploy AI models tailored to specific needs in R&D, manufacturing, and commercial operations. Ensure AI solutions are interpretable, scalable, and integrated into workflows across the E2E value chain, from lab to market. Regulatory & Ethical Compliance: Ensure AI solutions comply with global regulatory requirements (e.g., USFDA, EU, PMDA) and ethical standards across all stages of the pharmaceutical value chain, including manufacturing and commercial activities. Identify and mitigate risks related to AI deployment, such as data privacy, model bias, and compliance with Good Manufacturing Practices (GMP). Minimum Requirements Possess 6–8 years of core Business Analyst experience in the life sciences domain, with at least 3 years focused on AI technologies across the pharmaceutical value chain (R&D, manufacturing, and commercial operations), complemented by a master’s degree in Life Sciences, Biomedical Sciences, Computer Science, Data Science, or a related field. A PhD is a plus. Strong understanding of Generative AI, machine learning, and their applications in drug discovery, clinical trials, manufacturing, and commercial strategies. Proficiency in data analysis and visualization tools (e.g., Python, R, Tableau) to interpret complex datasets. Proven project management skills, with a track record of leading AI-related projects in at least one segment of the pharmaceutical value chain. Strong analytical and problem-solving abilities, with a strategic mindset and attention to detail. Exceptional communication and interpersonal skills, with the ability to mentor teams and influence stakeholders across R&D, technical operations, and commercial functions. Familiarity with pharmaceutical regulatory requirements (e.g., FDA, EMA, PMDA) and industry standards, including GMP and commercial compliance. Why consider Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn More Here https://www.novartis.com/about/strategy/people-and-culture Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Summary Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products’ life cycle. Provides safety support to the clinical development teams. About The Role Major accountabilities: Monitors the clinical safety of projects /products including activities such as literature review, evaluation of individual cases or signal detection, and responds to safety related questions appropriately . Performs medical assessment and related activities for cases whenever required, including collecting additional follow-up information as necessary, medical evaluation of product quality defects with adverse events, review of line listings of single cases, and preparation of investigator notifications and periodic medical assessments for ethics committees. Identifies safety signals based on the review of solicited or unsolicited single cases. Performs signal detection, monitoring and evaluation of all safety signals. Provides inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues. Prepares safety data for Health Authority review boards. Provides inputs to responses for legal queries and Country Organization requests involving safety issues. Provides expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on Novartis products. Collaborates productively on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments. Contributes to the development of departmental goals and objectives. Distribution of marketing samples (where applicable) Key Performance Indicators Timeliness and quality of safety analyses, interpretations, and presentations -Compliance with internal and external regulations and procedures -Compliance, consistency and quality of safety deliverables Minimum Requirements Work Experience: People Challenges. Critical Negotiations. People Leadership. Collaborating across boundaries. Operations Management and Execution. Skills Clinical Trials. Functional Teams. Literature Review. Management Skills. Medical Information. Medical Records. Medical Strategy. Pharmacovigilance. Regulatory Compliance. Risk Management. Safety Science. Languages English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Work Schedule Second Shift (Afternoons) Environmental Conditions Office Job Description Purpose: Subject matter expert of day-to-day application configuration and maintenance activities of the Pharmacovigilance (PV) Safety database Oracle Argus, ensuring that performed tasks comply with SOPs and policies, industry standards, and applicable regulations. Provides technical solutions, support systems implementation and testing following change control procedures and provide systems administration to support the requirements and initiatives of the PV Safety group. Responsibilities include but are not limited to: Collaborates with PV business users to understand the requirements and recommend solutions. Creates custom and ad-hoc reports from the PV Safety database using built in tools, OBIEE, or SQL. Develops and validates aggregate safety reports. Assists with internal and external audits of the PV Safety database. Interacts with project team or client and seeks feedback on deliverables. Provides programming support to project teams and clients for safety data review, ad-hoc reports and other activities. Leads project initiatives as needed, ensures desired outcome is achieved on time and in scope. Reviews and makes recommendations for process development and improvement. Manages assignment to meet timelines and deliver high quality work. Estimates effort to assist in bidding activities or cost construction. Qualifications: Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) Knowledge, Skills and Abilities: System administration experience in Oracle Argus including current knowledge of safety system configuration, database structure, mappings requirements and transformation rules Strong experience generating reports Strong SQL programming skills Knowledge of relational data base structure and experience working with complex data systems Proficient of one or more programming languages Strong attention to detail Problem solving skills Good written and verbal communications skills Ability to independently and effectively organize and manage multiple assignments with challenging timelines Ability to adapt and adjust to changing priorities Demonstrated leadership, initiative and motivation Ability to mentor and direct the work of junior staff Ability to communicates effectively within a multi-disciplinary team Ability to complete assigned tasks on time and within budget

Summary In this role, he will drive a strategic AI transformation across the pharmaceutical value chain, from drug discovery to commercialization, by leading enterprise-wide initiatives and coaching sub-ordinates to deliver high-impact solutions. About The Role Major Accountabilities Domain Expertise: Serve as a strategic expert in life sciences, providing leadership in applying Generative AI to drug discovery, clinical trials, regulatory affairs, pharmacovigilance, and market access. Drive thought leadership by identifying and promoting innovative Generative AI applications to position the organization as an industry leader. Business Analysis: Lead enterprise-wide initiatives to gather, analyze, and prioritize business requirements, aligning AI solutions with long-term organizational objectives. Oversee comprehensive analyses of complex business processes, designing AI-driven strategies to achieve operational excellence and competitive advantage. Authorize and review business cases, feasibility studies, and ROI analyses to secure executive approval for transformative AI initiatives. Ensure the creation of high-quality business requirements documents, process flows, and strategic roadmaps to guide enterprise-level AI implementations. Stakeholder Engagement: Act as a key liaison between C-suite executives, technical teams, and external partners, driving alignment on AI strategies and initiatives. Lead enterprise-level workshops, steering committees, and governance boards to shape AI adoption and ensure stakeholder buy-in. Represent the organization in industry forums and partnerships to advocate for AI-driven innovation in life sciences. Team Management and Coaching: Manage/mentor a team of Senior Specialist Business Analysts, providing strategic guidance, setting performance goals, and fostering professional development to ensure high-impact AI business use case delivery. Coach Senior Specialists in advanced business analysis techniques and Generative AI applications, enhancing their ability to address complex challenges in the life sciences domain and ensuring alignment with organizational objectives. Generative AI: Oversee the development and deployment of enterprise-scale Generative AI solutions, ensuring alignment with business needs and technical feasibility.s Collaborate with AI architects and data science leaders to define model architectures and deployment frameworks for life sciences applications. Ensure AI solutions are scalable, reliable, and fully integrated into mission-critical workflows. Regulatory & Compliance: Establish governance frameworks to ensure AI solutions comply with global regulatory standards (e.g., USFDA, EU, PMDA) and ethical principles. Lead risk management efforts, addressing ethical, legal, and operational risks associated with AI deployment in life sciences. Minimum Requirements 10–12 years of core Business Analyst or strategic consulting experience in the life sciences domain with at least 5 years leading AI technologies, supported by a Master’s degree in Life Sciences, Biomedical Sciences, Computer Science, Data Science, or a related field. A PhD or MBA is highly desirable. Expert understanding of Generative AI, machine learning, and their applications in life sciences. Proficiency in advanced data analysis tools (e.g., Python, TensorFlow, Power BI). Exceptional project management skills, with a proven track record of leading enterprise-scale AI projects (e.g., Agile, SAFe, or PMI methodologies). Superior analytical and problem-solving abilities, with a strategic mindset and ability to drive organizational change. Outstanding communication and leadership skills, with the ability to influence C-level stakeholders and lead cross-functional teams. Deep familiarity with life sciences/pharmaceutical regulatory requirements and industry standards. Why consider Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn More Here https://www.novartis.com/about/strategy/people-and-culture Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

PrimeVigilance (part of Ergomed Group) is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical device. We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Job Description The Financial Project Analyst has wide ranging responsibilities of PFA related duties. Work with Project Management Team to accurately forecast future units and revenue. Manage the financial health of our projects, working closely with the project to team to accurate record all financial data, report financial data clearly to the Project team. Monitor the total project cash positions. • Responsible for all the financial aspects of assigned projects • Ongoing maintenance of the financial and operational data within the companies’ management information structure • Creation and distribution of scheduled reports • Complete month end responsibilities including revenue recognition and forecasts, variance analysis, profitability analysis, and any other reporting needs as required • Support Proposals & Contracts and Project Directors on the development of financial analysis for proposals • Work closely with the Project Manager to provide on-going financial resource planning, management and analysis • Supports the overall health of assigned projects • Perform ad hoc financial analyses as requested by Project Managers and/or Department Heads Qualifications · BA/BS degree in Business, Accounting, Finance, or equivalent education and experience. · Demonstated relevant finance or accounting experience, project accounting/analysis a plus · Pharmaceutical or CRO experience is preferable · Strong proficiency in English · Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) is essential · Proficiency with accounting software packages · Experience with Oracle Finance is preferred · Knowledge in financial modelling techniques · Excellent analytical skills Additional information We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We offer: Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships Show more Show less

Job Description Regional Medical Advisor (RMA) – General & Specialty Medicine, South Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities And Primary Activities Scientific Expertise Develop and maintain a comprehensive understanding of the company's products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the company's products and therapeutic areas. Support to Medical Strategy Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the company's strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} Preferred Skills Job Posting End Date 06/30/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R350739 Show more Show less

*Greetings From You & I Consulting ! You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India. *Hurry Do Not Miss This Opportunity To Work For Global Giant MNC. We are hiring for the below locations under Medical Reviewer Role!! *Open Locations :- * Pune/ / Chennai / Mumbai *Mode Of Interview - Virtual *Mode Of Work :- Work From Office * CTC Upto - 10 To 24Lpa *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) or email your CV to puja@careersuni.com PFB Job Insights for Medical Reviewer Role!! Author a CCC for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. Detail any requests for changes to the case, including the narrative. Skills required:- Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills * * *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com ***Note we also have open positions for the below skills :- * * *Call Now our HR Specialist for more details:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com *Aggregate Reporting / Clinical Data Management / Clinical SAS / SQL Programmer / EDC Programmer / Medical Monitor / HEOR Health Economist Role / SAS + R / Statistical Programmer / Study Data Manager *Though We Try and Answer The Calls Immediately, but Due to Heavy Call Flow The Below Numbers Might Be Busy At Times. In case you find the number busy, please whatsapp your details to us in the below format: - Name- Mobile number - Mail - Qualification - Total work experience - Current Organization- Location - Last CTC Expected CTC:- *Interested candidates can even refer their friends or relatives provided the criteria *FOR interview Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com

Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives. Job Description Position Summary This role requires working as part of the Safety System Administrator Team performing database administration activities; supporting creation and upgrade of database instances; change control and data migration activities; first line user support and troubleshooting; and training users on databases. Principal Responsibilities The Safety System Administrator is primarily responsible for: Maintenance of database libraries Involvement in system validation activities Interrogating the database and generating outputs for internal and client use Training and providing database access to internal and client users Principle Functions For the Client (may include but is not limited to the following) Set up and maintenance of project specific database libraries including: Products Licenses Studies Reporting destinations Documenting and validating any change to the project specific database Support during legacy data transfer e.g., validation Supporting/providing guidance to the Project Manager / Client / Project Start Up Team during the development of project specific data handling guidelines (to ensure project specific guidelines are necessary and will not impact line listings and report generation) Prepare line listings and tabulations and other database outputs for use in aggregate reports, signal detection, reconciliation and other activities as required Provide case processing metrics required for invoicing (e.g., number of submissions, number of spontaneous vs initial cases processed) Provide database training to clients Providing and documenting client / internal team access upon receipt of an approved access request. For the Company (may include but is not limited to the following) Coordinate user access (including maintenance and revoking access) Maintain database procedures including core data handling conventions Provide database training and certification to PrimeVigilance users Provide user support Involvement in root cause investigation of database related deviations and ensure timely and complete documentation of resulting actions in line with Quality procedures Provide case processing quality and compliance metrics to the Quality Team Identify areas for improvement and address via training, clarifying changes to data handling guidelines, user guides etc. Execute business continuity periodic testing for database failure Ensure that existing software bugs, user requests, changes to regulatory requirements etc., are considered and appropriate changes are made and validated as required Support IT, database vendor and technical colleagues in troubleshooting and implementing software fixes and enhancements as required Other Supportive Responsibilities Assist PrimeVigilance senior management on an as needed basis. Potentially provide chargeable consulting / training activities to clients regarding Argus, and if required LSSMV. Qualifications Educated to degree standard Demonstrated work experience within Argus Safety Systems. Additional Information Why PrimeVigilance? We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We Offer Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join! We look forward to welcoming your application. Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships Show more Show less