Mandatory Skills & Expertise required: 2.6 to 4.5 years of experience in ICSR case processing (booking & Triage) Spontaneous / CT/ Literature case processing experience will also be considered. Good communications skill. Good understanding of medical terminology. Tools: Argus Data base / Aris-G / Life Sphere Multi - Vigilance (LSMV) (Optional)

Job Description JOB TITLE: Senior Medical Writer JOB SUMMARY Serves as a senior medical writer on clinical study or regulatory or publication project teams. Writes, edits, and coordinates content for clinical/regulatory/scientific while serving as primary technical contact with the internal team and the client. JOB RESPONSIBILITIES Mentors and leads less experienced medical writers on complex projects, as necessary. Acts as lead for assigned writing projects. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Develops or supports a variety of documents that include, but not limited to: Clinical journal manuscripts, clinical journal abstracts, posters, and oral presentations. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Serves as peer reviewer on internal review team providing review comments on draft and final documents. Adheres to established regulatory standards, including but not limited to Journal/congress specific 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. Familiarity with figure-creation and data visualization software, including tools such as GraphPad Prism and Adobe Illustrator, for developing high-quality scientific figures and graphics. Familiarity with publication planning software e.g. Datavision and PubConnect (VeevaVault Promo mats) Reviews deliverables for scientific accuracy, data and referencing quality, appropriate style, and correct branding of scientific/medical assets. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing. Maintains awareness 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%). QUALIFICATION REQUIREMENTS Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach. Strong proficiency in Word, Excel, PowerPoint, email, and Internet. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

Description Safety & PV Specialist I (Gurgaon / Hyderabad Location) 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 Looking for min 2.5 yrs of experience in PV Should have ICSR case processing and Argus experience. Office based opportunity 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: Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job. Safety Database systems and knowledge of medical terminology required. Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet. Ability to work independently and in a team environment. Excellent communication and interpersonal skills, both written and spoken. Good organizational skills with proven ability to prioritize and work on multiple tasks and projects. Detail oriented with a high degree of accuracy and ability to meet deadlines. 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. Summary Roles within Pharmacovigilance & Safety job family are responsible for providing expertise on pharmacovigilance services. This includes participating in all aspects of the medical safety team's involvement in assigned trials, such as performing medical review and clarification of trial-related Adverse Events, providing aggregate reviews of safety information, and serving as an internal consultant to pharmacovigilance case processing teams. Provides and contributes trends and safety signal detection and risk management assessment and provides safety support to the clinical development teams. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Entry to developing individual contributor. Delivers work of limited scope, typically smaller, less complex projects. Requires theoretical knowledge of a professional area, typically obtained through education and/or prior experience.

Description Office Manager 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. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. 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 JOB SUMMARY Experienced and dynamic individual responsible for all service and operations for the site(s). This role will oversee all aspects of the facility’s operations, including maintenance, space planning, vendor management, safety protocols, budgeting and ensuring a productive work environment. Lead and provide strategic direction to a team of professionals. Primary focus is ensuring a safe, efficient, and comfortable working environment for all employees while providing leadership and guidance to your team. Job Responsibilities Develop and implement comprehensive facility management. Lead and manage a team of professionals, providing direction, support, and guidance to ensure the successful execution of their responsibilities and development. Oversee the day-to-day operations and maintenance of office facilities, ensuring compliance with in country regulatory requirements and industry standards. Develop and implement policies, procedures, and best practices related to office operations and maintenance. Collaborate with cross-functional teams, such as IT, HR, Legal/Compliance and Finance, to ensure seamless coordination of office-related activities. Manage vendor relationships, including procurement, contract negotiation, performance evaluation, and issue resolution. Serve as point of contact for landlord relations; address any facility-related concerns or issues with the landlord as necessary. Develop and manage the office facilities budget, ensuring cost-effective solutions without compromising quality or safety. Conduct regular inspections of the office premises to identify maintenance needs or potential safety hazards; coordinate necessary repairs or improvements. Implement energy management strategies to optimize energy usage and promote sustainability initiatives within the office. Oversee space planning initiatives, including office moves, additions, changes, and furniture procurement. Ensure proper inventory management of office consumables, equipment, and supplies. Coordinate emergency response plans and drills to ensure the safety and security of employees in case of emergencies. Maintain accurate records related to office facilities management activities, including maintenance logs, vendor contracts, and compliance documentation. Stay updated on industry trends and best practices in office facilities management; recommend improvements or innovative solutions as appropriate. Foster a positive work environment by promoting teamwork, collaboration, and employee engagement within the office facilities team. Minimum travel may be required (up to 25%). Qualification Requirements Bachelor's degree in facilities management, business administration, or a related field preferred. Require 3+ experience in office facilities management or Ops manager Strong knowledge of facility management principles and best practices. Excellent leadership skills with the ability to motivate and inspire a team. Strong organizational and time management skills with the ability to prioritize tasks effectively. Excellent communication and interpersonal skills with the ability to interact with employees at all levels of the organization. Ability to handle people, stakeholders- managing stakeholder request, facility handling Knowledge of health and safety regulations and practices. Experience in vendor management and contract negotiation. Ability to handle confidential information with discretion and maintain a high level of professionalism. Flexibility to adapt to changing priorities and handle multiple tasks simultaneously. Good to have team handling experience http://synh-my.sharepoint.com/:w:/r/personal/melissa_wilson_syneoshealth_com/Documents/CRES%20JDs/A%20-%20Syneos%20Health%20JD%20.%20Office%20Manager.docx?d=w523f8c493c7c40e3964c639d8e842e02&csf=1&web=1&e=JCigQQ 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. Summary As per the JD for this role

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. 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. WhyBecause 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 Looking for min 2.5 yrs of experience in PV Should have ICSR case processing and Argus experience. Office based opportunity 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: Bachelors Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job. Safety Database systems and knowledge of medical terminology required. Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet. Ability to work independently and in a team environment. Excellent communication and interpersonal skills, both written and spoken. Good organizational skills with proven ability to prioritize and work on multiple tasks and projects. Detail oriented with a high degree of accuracy and ability to meet deadlines.

We are seeking a highly skilled QA Tester/Test Automation Engineer to design, develop, and maintain automation solutions across multiple applications and platforms. The ideal candidate is passionate about quality engineering, experienced in modern automation frameworks, and capable of driving automation adoption in agile delivery environments. This role will play a key part in increasing automation coverage, improving release quality, reducing testing cycle times, and ensuring a scalable and reliable automation approach across the organization. Key Responsibilities Automation Development Design and build automated test scripts for web, API, backend, and functional scenarios. Develop scalable automation suites aligned to sprint and release cycles. Contribute to reusable automation libraries, utilities, and test data components. Ensure automation scripts meet coding standards and trace back to clear requirements. Continuous Quality Execution Support CI/CD integration for automated testing execution. Configure automation execution pipelines and generate automated reports. Use automation results to proactively identify defects and quality trends. Test Strategy & Collaboration Work closely with product owners, dev teams, and QA analysts to define test coverage. Perform requirement analysis to identify automation scope early (shift-left approach). Participate in sprint ceremonies and represent automation within the delivery team. Provide estimation and effort planning for automation tasks. Documentation & Governance Maintain script versioning, execution logs, and documentation. Support traceability, risk-based testing, and validation evidence where applicable. Required Qualifications 2 5 years of hands-on experience in automation engineering. Strong hands-on experience in at least one of the following: Playwright Selenium Cypress Provar (for Salesforce projects) Strong scripting/programming skills in: TypeScript / JavaScript or Java / Python Experience with API automation tools (eg, Postman, RestAssured). Solid understanding of CI/CD platforms such as Azure DevOps, GitHub Actions, or Jenkins. Experience executing automation within agile delivery models. Good knowledge of test design techniques (boundary, equivalence, data-driven, risk-based testing). Preferred Experience Experience automating Salesforce applications (eg, Health Cloud, Data Cloud, Lightning UI). Hands-on experience building reusable automation frameworks. Knowledge of performance or accessibility automation tools. Experience in a regulated or validated environment (eg, GxP). ISTQB or QA-related certification. Exposure to cloud environments (AWS, Azure). Soft Skills Strong analytical thinking and troubleshooting skills. Excellent verbal and written communication. Self-driven with strong ownership and accountability. Able to collaborate effectively with cross-functional teams. Passionate about mentoring others on automation best practices.

We are seeking a highly skilled QA Tester/Test Automation Engineer to design, develop, and maintain automation solutions across multiple applications and platforms. The ideal candidate is passionate about quality engineering, experienced in modern automation frameworks, and capable of driving automation adoption in agile delivery environments. This role will play a key part in increasing automation coverage, improving release quality, reducing testing cycle times, and ensuring a scalable and reliable automation approach across the organization. Key Responsibilities Automation Development Design and build automated test scripts for web, API, backend, and functional scenarios. Develop scalable automation suites aligned to sprint and release cycles. Contribute to reusable automation libraries, utilities, and test data components. Ensure automation scripts meet coding standards and trace back to clear requirements. Continuous Quality Execution Support CI/CD integration for automated testing execution. Configure automation execution pipelines and generate automated reports. Use automation results to proactively identify defects and quality trends. Test Strategy & Collaboration Work closely with product owners, dev teams, and QA analysts to define test coverage. Perform requirement analysis to identify automation scope early (shift-left approach). Participate in sprint ceremonies and represent automation within the delivery team. Provide estimation and effort planning for automation tasks. Documentation & Governance Maintain script versioning, execution logs, and documentation. Support traceability, risk-based testing, and validation evidence where applicable. Required Qualifications 2 5 years of hands-on experience in automation engineering. Strong hands-on experience in at least one of the following: Playwright Selenium Cypress Provar (for Salesforce projects) Strong scripting/programming skills in: TypeScript / JavaScript or Java / Python Experience with API automation tools (eg, Postman, RestAssured). Solid understanding of CI/CD platforms such as Azure DevOps, GitHub Actions, or Jenkins. Experience executing automation within agile delivery models. Good knowledge of test design techniques (boundary, equivalence, data-driven, risk-based testing). Preferred Experience Experience automating Salesforce applications (eg, Health Cloud, Data Cloud, Lightning UI). Hands-on experience building reusable automation frameworks. Knowledge of performance or accessibility automation tools. Experience in a regulated or validated environment (eg, GxP). ISTQB or QA-related certification. Exposure to cloud environments (AWS, Azure). Soft Skills Strong analytical thinking and troubleshooting skills. Excellent verbal and written communication. Self-driven with strong ownership and accountability. Able to collaborate effectively with cross-functional teams. Passionate about mentoring others on automation best practices.

The Technology & Data Solutions (TDS) business unit is the Syneos Health accelerator for life sciences innovation. TDS houses advanced technology acquisitions, homegrown products and applications, actively participates in new M&A and partnership activities, delivers critical insights as part of our integrated strategy for customers, and drives enterprise-wide adoption and change management for innovative tech and data solutions. Our work supports bringing meaningful new medicines to patients faster, with greater positive impact. The Senior Director, Engineering (Data & Master Data Management) supports these goals by leading global engineering teams that design, build, and maintain high-quality data-centric and master data solutions addressing complex business and customer needs. This role is heavily focused on Master Data Management, data engineering, data integrity, and foundational data capabilities, while partnering closely with product and business stakeholders in a highly dynamic environment. Core Responsibilities Lead and develop teams of managers and engineers across onshore and offshore locations, including line management, performance management, professional development, interviewing, and onboarding. Combine strong technical depth with people leadership skills to effectively lead teams of teams. Set clear goals aligned to business strategy and customer expectations; facilitate resourcing and coordination of work across multiple initiatives. Lead engineering teams to deliver high-quality, scalable, and timely data and master data solutions. Own and prioritize the technical backlog, with a strong focus on master data, data engineering, and data quality initiatives. Partner closely with product management, engineering leadership, and technical leads in strategic planning and execution. Drive technical decision-making and work with product managers to manage backlogs supporting multiple engineering teams. Oversee technical architecture for master data platforms, data pipelines, analytics enablement, dashboards, and custom tools, ensuring data integrity and governance. Support teams in presenting findings and recommendations to internal and external stakeholders in a clear, concise, and business-relevant manner; assist with client queries or escalations as needed. Oversee production schedules, test plans, documentation, and presentation materials that define project milestones and delivery standards. Mentor and coach junior team members across the organization, fostering autonomy, accountability, and strong engineering practices. Foster collaboration across global teams toward shared objectives and outcomes. Stay current with industry trends in data engineering, master data management, and life sciences data, sharing relevant insights with senior leadership. Communicate and collaborate effectively across internal functions to drive optimal business outcomes in a fast-paced, change-oriented environment. Qualifications Education BS/BA required; MS/MA preferred in Information Systems, Computer Science, Software Engineering, Data Science, Engineering, Statistics, or a related field. Additional Qualifications Proven experience in a senior engineering leadership, data engineering, or solutions architecture role delivering data-centric and master data driven solutions. Strong experience with Master Data Management platforms (eg, Reltio strongly preferred). Hands-on experience with modern cloud data ecosystems such as Azure, Databricks, and Snowflake. Strong background in data modeling, data quality, data governance, and data integrity. Experience leading high-performing, globally distributed teams and working across multiple stakeholders to deliver results. Ability to influence, align, and partner effectively with peers and senior leadership. Excellent verbal and written communication skills, with the ability to translate complex technical concepts into business-relevant insights. Experience working within life sciences, clinical research, pharma, or CRO environments is highly preferred. Familiarity with healthcare and clinical data domains (eg, Rx data, medical claims, ICD, HCPCS, NPIs) is a strong plus. Comfortable operating in environments with evolving requirements and ambiguity, demonstrating sound judgment and adaptability

Description Market Analyst 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. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life. 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 This position will serve as the primary point of contact for data and insights requests from marketing leadership. Will partner closely with data stakeholders and manage data tools. Focused on delivering both marketing and business development metrics and insights. Must have experience using data aggregation tools to build insight-driving and reporting at scale with the ability to work directly across digital platforms, be facile with analytics from various sources and be able to extract actionable business insights. Role will regularly report out to business identifying opportunities, establishing metrics to measure performance and identify opportunities for optimization. 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. Summary This position will serve as the primary point of contact for data and insights requests from marketing leadership. Will partner closely with data stakeholders and manage data tools. Focused on delivering both marketing and business development metrics and insights.

Description Market Analyst 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. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life. 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 This position will serve as the primary point of contact for data and insights requests from marketing leadership. Will partner closely with data stakeholders and manage data tools. Focused on delivering both marketing and business development metrics and insights. Must have experience using data aggregation tools to build insight-driving and reporting at scale with the ability to work directly across digital platforms, be facile with analytics from various sources and be able to extract actionable business insights. Role will regularly report out to business identifying opportunities, establishing metrics to measure performance and identify opportunities for optimization. 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. Summary This position will serve as the primary point of contact for data and insights requests from marketing leadership. Will partner closely with data stakeholders and manage data tools. Focused on delivering both marketing and business development metrics and insights.

Description Medical Writer II (Clinical Trial Transparency) 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 1 to 3 years of experience in Disclosure. Knowledge of Clinical Research, Clinical Trial, clinical registries (CT.gov, CTIS- Clinical Trial information System, EUDRACT). Experience in clinical registries, clinical trial Disclosure is mandatory. Experience in databases like Pharma CM/ Disclose. Good understanding of protocol registration process. Fine with candidate with combination of redaction Disclosure. Mentors less experienced medical writers on projects, as necessary. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format. 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. Working knowledge of drug development process and regulatory guidelines. Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing. Stays 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: Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred. Client interaction experience. Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required Experience writing relevant document types required Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style Necessary Skills: Strong presentation, proofreading, collaborative, and interpersonal skills Strong project and time management skills Strong proficiency in MS Office Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information 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.

Description Regulatory Consultant/Sr. Consultant - RIM/Veeva Business Analyst (US timeshift) 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 General Responsibilities : Look for system/process-focused analysts with RIM/Veeva experience. Excellent communication and stakeholder management skills. Master’s degree with overall 8+ years’ experience Experience in system requirement gathering, validation, and user acceptance testing. Ability to collaborate across cross-functional teams (Reg Ops, IT, Process Development etc). Note: Exclude candidates whose experience is limited to regulatory publishing/submissions. Availability in EST timezone for collaboration purposes. Core Responsibilities: Act as the primary liaison between Regulatory Operations teams and IT/Tool Management teams. Focus on technology enablement and process optimization. Gather and document requirements from key users (business partners, RIM superusers, technical leads). Ensure requirements are maintained and updated in alignment with business needs. Collaborate with DTE and Validation teams. Support user testing activities, including preparation of test scripts and execution oversight. Serve as SME for RIM systems. Provide guidance, communication, and training to users on business tools and processes. Work closely with IT and process development teams to manage RIM system enhancements. Collaboration with global teams to coordinate system inputs, validate data, resolve missing fields or gaps, and support end-to-end system workflows. Contribute to continuous improvement initiatives. 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.

Description Sr. Medical Writer Clinpharm (CSR, IB, protocol) 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 Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client. Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. 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, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget. Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads team document reviews, and reviews documents as needed. Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format. 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 and document needs. Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. Performs online clinical literature searches and complies with copyright requirements. Identifies and proposes solutions to resolve issues, escalating as appropriate. Provides technical support, training, and consultation to department and other company staff. May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities. Mentors and leads less experienced medical writers on complex projects, as necessary. Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership. Completes required administrative tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications: 3-5 years of relevant experience in science, technical, or medical writing. Experience working in the biopharmaceutical, device, or contract research organization industry required. Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required. Experience writing relevant document types required. Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style. 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. Summary Roles within the Medical Writing job family are responsible for writing and editing manuscripts and other medical communications on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication such as screening, analyzing, and summarizing additional data from other sources as needed. Conducts systematic literature searches and reviews. Prepares literature for new products and revises existing medical communication. Reviews and analyzes statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. Supports engagement and interaction with regulatory agencies through preparation of briefing books and response documents to health authority questions. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Individual contributor with developing subject matter expertise and responsibility for processes. In-depth knowledge and skills within a professional discipline, understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.

Description Regulatory Consultant/Sr. Consultant - RIM/Veeva Business Analyst (US timeshift) 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 General Responsibilities : Look for system/process-focused analysts with RIM/Veeva experience. Excellent communication and stakeholder management skills. Master’s degree with overall 8+ years’ experience Experience in system requirement gathering, validation, and user acceptance testing. Ability to collaborate across cross-functional teams (Reg Ops, IT, Process Development etc). Note: Exclude candidates whose experience is limited to regulatory publishing/submissions. Availability in EST timezone for collaboration purposes. Core Responsibilities: Act as the primary liaison between Regulatory Operations teams and IT/Tool Management teams. Focus on technology enablement and process optimization. Gather and document requirements from key users (business partners, RIM superusers, technical leads). Ensure requirements are maintained and updated in alignment with business needs. Collaborate with DTE and Validation teams. Support user testing activities, including preparation of test scripts and execution oversight. Serve as SME for RIM systems. Provide guidance, communication, and training to users on business tools and processes. Work closely with IT and process development teams to manage RIM system enhancements. Collaboration with global teams to coordinate system inputs, validate data, resolve missing fields or gaps, and support end-to-end system workflows. Contribute to continuous improvement initiatives. 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.

Description HR Analyst II 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. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. 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 Design, develop, and maintain interactive dashboards and visualizations using Power BI to support strategic initiatives. Extract, analyse, and interpret data from Workday and other HR systems to generate custom reports for leadership. Perform trend analysis, headcount tracking, and workforce metrics reporting. Collaborate with cross-functional teams to understand reporting needs and translate them into actionable insights. Ensure data accuracy, integrity, and consistency across all reports and dashboards. Automate recurring reports and streamline reporting processes using Advanced Excel techniques (e.g., pivot tables, macros, formulas). Present findings and recommendations to leadership in a clear and compelling manner. Support ad-hoc data requests and special projects as needed. 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.

Description Dir, HR Business Delivery PTNR 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. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. 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 Job Summary Provides HR consulting and coaching to business leaders, addressing people and cultural challenges. Supports organizational change, including talent integration during mergers and restructuring. Advocates for HR programs by communicating value and managing smooth rollouts. Collaborates with talent management on workforce planning, succession, and development initiatives. Impact and Contribution: This role provides strategic vision and tactical direction across their area or organization. Focuses on overseeing responsibilities, planning, prioritizing, and managing the performance of direct and indirect reports. Manages both managers and individual contributors to achieve operational goals. Contributes to operational plans with measurable impact on short-term department results. Possesses deep knowledge in a specific discipline and practical experience managing processes, projects, and tactics. Core Responsibilities Lead and develop a high-performing team to deliver efficient, scalable, and globally aligned HR services fostering a high-performance culture and supporting career growth. Provide strategic operational direction to ensure consistent execution of HR processes. Foster a culture of collaboration, accountability, and continuous improvement across HR operations. Drive key business initiatives, support annual HR processes, and deliver direct-line support to select leaders. Direct the daily operations of the HR Business Delivery Partner team for the assigned business line, ensuring alignment with business unit and functional priorities. Oversee the execution of core HR processes (e.g., compensation, performance reviews, bonus cycles) to ensure consistency, compliance, and timeliness. Monitor and improve service delivery metrics, identifying opportunities for process optimization and automation. Conduct regular performance reviews, provide feedback, and implement development plans to build team capabilities. Promote a collaborative and inclusive team environment that values diversity and innovation. Support efficient and scalable HR Services. Provide high-quality HR services aligned to specific business unit and functional priorities that meet global HR standards, while reinforcing employee and manager self-service. Lead Annual HR Cycles. Oversee and ensure the successful execution of core annual HR processes—including performance reviews, compensation planning, and bonus administration— by collaborating with aligned teams to maintain consistency, timeliness, and compliance across the organization. Provide Strategic HR Support to Key Leaders. Serve as a primary HR contact for designated leaders and HR Partners, offering expert counsel on complex employee relations matters and talent strategies. Support the implementation of key business initiatives and act as an escalation point for high-impact or sensitive HR issues. Leads and coordinates the execution of annual HR processes—including performance evaluations, compensation planning, and bonus administration—to ensure timely, consistent, and effective delivery aligned with organizational goals. Provide strategic HR support to assigned leaders and HR partners by offering expert guidance on complex employee relations issues and talent strategies, while also serving as a point of escalation and supporting the implementation of key business initiatives. Understand the BU’s operating environment and apply awareness of the BU’s goals and objectives when designing workforce plans (including restructuring) Support the ongoing relationships with the aligned HRBPs and BU leaders to drive employee engagement at the business unit level. Support the HRBP/Lead with data insights regarding the workforce and solutioning business challenges to translate them into talent actions. Collaborate with PSN Team. Work closely with a diverse, global/regional PSN team to ensure alignment with organizational goals, direct in-market support and delivery at scale around the world. Work Cross-Functionally with HRBPs and Leads. Support and engage with HRBPs and other stakeholders to ensure effective, scalable and consistent delivery of core HR services, including annual programs, key metric reporting aligned to assigned teams, and talent strategies. Enhance Employee Engagement. Support initiatives that enhance employee engagement, including targeted team talent strategies and other key business initiatives. Coach Managers and Employees. Provide performance guidance and engagement counsel to managers and employees, fostering a supportive and productive work environment. Qualifications Education Requirements Min/Preferred Education Level Description Minimum 4 Year / Bachelors Degree Bachelor’s degree in human resources, Business Administration, or a related field; master’s degree preferred. Additional Qualifications Progressive HR experience, that includes leadership or managerial role. Proven track record in HR operations, team leadership, and cross-functional collaboration. Strong analytical, organizational, and communication skills. Proficient in utilizing data analysis tools, techniques and methods to interpret datasets and determine a direction forward. Ability to target communication to specific audiences demonstrating strong executive presence. Appreciation for composure under pressure. Experience working in a global, matrixed organization with diverse teams. Experience with data-driven decision making. Experience in managing cross-cultural teams and understanding of global HR practices. 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. Summary Provides HR consulting and coaching to business leaders, addressing people and cultural challenges. Supports organizational change, including talent integration during mergers and restructuring. Advocates for HR programs by communicating value and managing smooth rollouts. Collaborates with talent management on workforce planning, succession, and development initiatives. Impact and Contribution: This role provides strategic vision and tactical direction across their area or organization. Focuses on overseeing responsibilities, planning, prioritizing, and managing the performance of direct and indirect reports. Manages both managers and individual contributors to achieve operational goals. Contributes to operational plans with measurable impact on short-term department results. Possesses deep knowledge in a specific discipline and practical experience managing processes, projects, and tactics.

Description L&D Trainer 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. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. 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 Delivers professional or functional training to transfer knowledge or support the development of new skills. Delivers training, in-person or virtually, via seminars, lectures, workshops or team exercises. Delivers high quality, internal training, either in-person or virtually, utilizing the best modality for the content and learning objectives. Utilizes best-in-class facilitation skills and technology to conduct training. Incorporates knowledge of cultural differences into delivery of content. Develops training delivery schedule and cadence to meet business needs. Schedules training in enterprise Learning Management System (LMS). Schedules logistics for training delivery (room, facilities, catering, etc.). Coordinates rosters of participants. Collaborates with subject matter experts / guest presenters to gather their input during training delivery. Develops / reproduces / acquires classroom materials. Provides feedback to instructional designers / course owners on content and makes recommendations for improvements. Collects course feedback forms (level one (1) evaluation). Submits roster to LMS Administrator so participants can obtain credit for the course. Responds to class inquiries and / or forwards to the appropriate representative. Creates training materials that are clear, current, meet specified training objectives and are appropriate for global audiences. 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. Summary Delivers professional or functional training to transfer knowledge or support the development of new skills. Delivers training, in-person or virtually, via seminars, lectures, workshops or team exercises.

Description Safety & PV AI and Machine Learning Specialist 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 Job Title: Safety & Pharmacovigilance (PV) AI and Machine Learning Specialist Department: Safety & Pharmacovigilance (Safety Tech / PV Innovation) Reports To: Director, Pharmacovigilance Position Overview The Safety & PV AI and Machine Learning Specialist will serve as a key technical and strategic contributor to Syneos Health's Safety & Pharmacovigilance (PV) AI enablement initiatives. This role will focus on the exploration, development, and implementation of artificial intelligence (AI), machine learning (ML), and automation solutions to enhance pharmacovigilance processes, improve efficiency, and maintain compliance with global regulatory standards. The ideal candidate brings a blend of pharmacovigilance or life sciences domain knowledge and hands-on AI/ML development experience , with strong capabilities in building proof-of-concept (POC) AI agents, writing effective prompts, and applying AI responsibly in a regulated environment. Key Responsibilities AI Solution Design & Development Design, build, and test AI/ML-based prototypes and proof-of-concept solutions for PV workflows (e.g., case intake, triage, data extraction, signal detection, narrative generation). Develop and optimize prompt engineering strategies for large language models (LLMs) to support PV automation and decision support use cases. Partner with Safety Tech, IT, and PV Operations to translate operational challenges into AI opportunities. Technical Implementation & Integration Evaluate and integrate AI technologies and APIs (e.g., NLP, generative AI, computer vision, process automation) into existing PV systems or processes. Collaborate with developers and data engineers to ensure scalable, compliant implementation of AI tools. Data & Model Governance Support model evaluation, validation, and monitoring activities to ensure accuracy, reliability, and compliance with regulatory standards. Contribute to AI governance frameworks including documentation, explainability, and risk management in line with GxP, GDPR, and 21 CFR Part 11. Collaboration & Knowledge Sharing Work cross-functionally with Safety Operations, Data Science, IT, and Business Analysts to align AI initiatives with PV business needs. Provide subject matter expertise on AI trends, tools, and best practices relevant to drug safety and life sciences. Qualifications Education Bachelor's or Master's degree in Life Sciences, Computer Science, Data Science, Engineering, or related field. Advanced degree preferred. Experience 35+ years of experience in pharmacovigilance, drug safety, or life sciences operations and/or experience developing AI/ML solutions within a regulated industry. Demonstrated experience with: AI/ML model development and deployment (e.g., Python, TensorFlow, PyTorch, Scikit-learn, Hugging Face, OpenAI API). Natural Language Processing (NLP) and Large Language Model (LLM) applications. Prompt design and optimization for LLM-based agents. Building proof-of-concept (POC) or pilot AI applications. GPT4.0+ Understanding of GxP, 21 CFR Part 11, and data privacy requirements in the pharmaceutical industry. Understanding of global AI specific regulations and guidelines. Preferred Skills Experience with safety databases, case processing systems, or pharmacovigilance workflows. Familiarity with automation and RPA tools. Strong analytical, communication, and documentation skills. Ability to communicate complex technical concepts to non-technical stakeholders. Passion for innovation, continuous improvement, and responsible AI. Location & Work Environment Remote (Serbia or Bulgaria preferred) Collaboration across global teams in multiple time zones. Why Join Syneos Health You'll be part of a forward-thinking pharmacovigilance team that's shaping the future of safety operations through ethical, compliant, and impactful use of AI. This is an opportunity to blend scientific expertise with cutting-edge technology to improve patient safety outcomes worldwide. 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. Summary The Safety & PV AI and Machine Learning Specialist will serve as a key technical and strategic contributor to Syneos Health's Safety & Pharmacovigilance (PV) AI enablement initiatives. This role will focus on the exploration, development, and implementation of artificial intelligence (AI), machine learning (ML), and automation solutions to enhance pharmacovigilance processes, improve efficiency, and maintain compliance with global regulatory standards.

Description Publisher II (CSR , IB , Protocol publishing) 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 Primary responsibility for all components of document compilation and publishing Requires good working knowledge of FDA, EU, ICH and ISO guidelines to ensure submission documents meet or exceed sponsor and regulatory requirements and guidance. Responsible for the thorough peer review of published documents created within or outside of the Company, when applicable. Interacts with medical writers and medical editors in the medical writing department Interacts with cross-functional project teams within the Company (Project Leads, Clinical, Data Management, Regulatory Consulting, and Biostatistics), and with clients as applicable. Assists in training and mentoring Publisher I staff. Performs other work-related duties as assigned. 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. Summary Provides advanced document-level compilation and publishing services for Medical Writing, including clinical study reports (CSRs); protocols and protocol amendments; investigator brochures; annual reports, and other regulatory documents that meet current ICH electronic document requirements and guidelines. Interacts with the medical writing department and with project teams within the company (Project Leads, Clinical, Data Management, Regulatory Consulting, Biostatistics), and in some cases direct contact with clients to ensure that all regulatory specified documents are complete, accurate, and compatible with sponsor and regulatory agency software programs.

Description Safety & PV Specialist I - Mandarin/Chinese Speaker 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 testsCompiles 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: Education & Experience: Bachelor's degree in Life Sciences, Nursing, Pharmacy, or an equivalent combination of education and experience providing the knowledge, skills, and abilities required for the role. Science graduates preferred; fresher candidates are welcome. Prior experience in Pharmacovigilance/Drug Safety is a plus. Language Skills: Mandarin/Chinese Proficiency: HSK 4 minimum; HSK 5+ preferred Writing: Critical Speaking: Conversational level acceptable Translating: Highly important Technical & Professional Skills: Experience with Safety Database systems and knowledge of medical terminology Understanding of clinical trial processes (Phases IIIV) and/or post-marketing safety requirements, including ICH GCP, GVP, and related regulations Proficient in MS Office (Word, Excel, PowerPoint), Visio, Outlook, Team Share, and internet tools Ability to work independently and in a team environment Excellent communication, interpersonal, and organizational skills Detail-oriented with high accuracy and ability to meet deadlines Shift Timings: Tuesday to Saturday, 3 PM 12 AM (night) Flexibility may be required based on business needs; shift extensions may be necessary 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. Summary Roles within Pharmacovigilance & Safety job family are responsible for providing expertise on pharmacovigilance services. This includes participating in all aspects of the medical safety team's involvement in assigned trials, such as performing medical review and clarification of trial-related Adverse Events, providing aggregate reviews of safety information, and serving as an internal consultant to pharmacovigilance case processing teams. Provides and contributes trends and safety signal detection and risk management assessment and provides safety support to the clinical development teams. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Entry to developing individual contributor. Delivers work of limited scope, typically smaller, less complex projects. Requires theoretical knowledge of a professional area, typically obtained through education and/or prior experience.