4 Pharmacovigilance Regulations Jobs

Safety Analyst (Intern) **Good communication is must This position supports of the Pharmacovigilance (PV) Department as both a key team member and contributor in the scheduling and development of aggregate safety reports, generation of project and safety or signal report specific line listings, risk management materials, and safety data compilation from clinical trials and spontaneous post-marketing reports and other sources. ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: Plays an essential role supporting PV Operational Delivery to facilitate and meet client project deadlines for various aggregate and signal reports, line listings, and safety data compilation as required by client. Manages the operational aspects of aggregate safety reporting . Provides pharmacovigilance data analysis, authoring, and quality control (QC) expertise for the preparation of Periodic Adverse Drug Experience Reports (PADER) Support drafting of assigned sections of other aggregate reports like Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR) / Periodic Benefit Risk Evaluation Reports (PBRER), Annual Safety Reports (ASR), and IND Annual Reports and client specific signal detection reports. Generate aggregate reports line listings as required to meet regulatory requirements and contracted deliverables for client projects Collaborates with various stakeholders to ensure that outputs from the safety database meets the need for preparation through submission of aggregate safety reports, while maintaining compliance with regulatory timeline(s). Thorough understanding and adherence to aggregate safety reporting processes and procedures, safety management plans (SMP), and safety data exchange agreement(s) (SDEA) / Pharmacovigilance Agreement(s) (PVA). Knowledge of clinical trial methodology, pharmacovigilance regulations, safety data analysis, benefit-risk assessment, drug development, and post-marketing requirements. Familiar with safety database(s) (e.g., ARGUS, ARISg) and MedDRA. Strong attention to detail with a proactive persistence approach to following tasks through to completion. Support PV Operations, PV audits and inspections Draft other safety writing deliverables as needed. All other duties as assigned. Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias. All other duties as assigned. EXPECTIONS OF THE JOB: Responsible to deliver CLIENT DELIGHT Responsible to identify, deploy, oversees, mentor direct reports and consultants supporting various clients Responsible to work collaboratively with EVERSANA PV team and take direction and feedback from management and clients Responsible to ensure management and compliance with industry standards and codes of practice Able to work independently to develop high-quality, scientifically accurate, strategically aligned, ethical, and compliant medical content Responsible to proactively flag and manage any quality issues, and ensure timely corrective and preventive actions MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. BS degree in a life science discipline (e.g., pharmacy, nursing) is preferred Broad knowledge of domestic and international drug safety regulations, industry practices and standards Strong attention to detail, teamwork, and initiative Strong understanding of drug development, drug safety reporting, as well as an appreciation for the importance of regulatory compliance Familiarity with FDA and international adverse event reporting regulations per ICH guidelines Understanding of medicalterminology and familiarity with principles of adverse event reporting in the pharmaceutical industry is a plus Must be quality oriented and demonstrate consistent attention to detail Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required Show more Show less

Serves as a Subject Matter Expert (SME) within the PS Technical Solutions Team for reporting systems, ensuring they are capable of delivering high quality expertise and services across the PV systems estate, ensuring prioritized requirements and the strategic goals of stakeholders are understood and supported. Manages applicable tools, documentation and methodologies to ensure the reporting needs of organization are fully addressed and supported. Responsibilities of PV systems inclusive of relevant system processes, ensuring that the: System is changed in an effective and timely manner to meet new health authority requirements and / or changed business demands (e.g. divestment, in-licensing, partnership etc.). Technical components of the system are upgraded in a compliant and risk-minimized manner. Lead and coordinate routine system maintenance activities (e.g. MedDRA, WHODD, Ontology updates) System enhancement requests are identified and prioritized (change control and major change projects). Access to data is controlled, training requirements are defined and use of the system is compliant with all applicable regulations. User support arrangements (e.g. training, helpdesk) and Service Level Agreements are in place, irrespective of whether delivered internally or by external vendors / providers. Supports the ongoing business utilization of PS systems, including troubleshooting problems and developing solutions. Provides technical input and guidance on the development of strategic plans for PS systems across the enterprise. Evaluates new modules and software upgrades and assesses the impact on system validation, the user community and PV processes. Retains a global perspective around the business need for accurate, high-quality, effective and efficient information, while maintaining a focus on regulatory and corporate compliance needs. Anticipates business, regulatory and wider industry trends, and apply these in the evolution and development of safety solutions. Accountable for ensuring the quality of business-related content of relevant improvement project proposals and associated documentation in line with Company goveranance process requirements. Contributes to the development of procedures, work instructions, system specifications related to the use GPS information sources and toolsets. Participates in interactions with interal and external partners and health authorities on electronic safety data exchange. Supports the GPS as required in the license partner/CRO pharmacovigilance agreement (PVA) process. Essential Skills/Experience Bachelor s degree in a scientific discipline with relevant experience in supporting safety-related activities in clinical biopharmaceutical development. Significant experience (10+ years) in pharmacovigilance with a proven record of supporting safety tools/solutions. Proven competence in designing, delivering, deploying, or maintaining information/systems solutions in support of safety. Broad knowledge of safety information tools required to support drug development and marketed brands within AstraZeneca. Ability to articulate complex safety-related business needs in the context of IS systems design, architecture, and development. Significant experience in system validation, audit, and PV inspection activities and requirements. Excellent interpersonal and communication skills with the ability to efficiently communicate with all levels of the organization. Desirable Skills/Experience Higher degree in a clinical or safety-related discipline. Awareness of broader technological developments leveraged to inform the design and development of AZ PV Systems. Ability to identify opportunities for continuous improvement based on strong awareness of external competitive practice. Ability to lead diverse teams across multiple geographies to deliver on objectives. Experience across multiple therapeutic or business areas or in safety-related roles within other biopharmaceutical, regulatory, or health organizations. Knowledge of procedures governing clinical trial data with health authorities worldwide and experience implementing these within the business. Experience working across different geographic locations, organizations, and cultures.

What you will do The primary responsibility of this role is to perform quality control reviews of of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures timelines are met. Key Responsibilities: Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure content accuracy, data integrity, formatting consistency, and adherence to regulatory and internal requirements. Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases. Collaborate with Periodic Report Specialists to address discrepancies and ensure timely resolution of quality issues. Maintain up-to-date knowledge of global regulatory requirements and industry standard methodologies for periodic safety reporting. Contribute to the development and refinement of QC checklists, templates, and SOPs to ensure consistent review practices. Track QC metrics and support continuous improvement initiatives related to safety report quality and delivery. Responsible for performing QC reviews of periodic safety reports to ensure compliance with the style guide, templates, and contributor inputs. Responsible for verifying content accuracy, data integrity, and consistency across all report components. Responsible for collaborating with Periodic Report Specialist to resolve QC findings and ensure timely delivery of high-quality reports. Inspection Readiness: Support inspection readiness efforts by ensuring all QC activities are well-documented, traceable, and compliant with applicable regulatory requirements. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree and 1 to 3 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Bachelors degree and 3 to 5 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Diploma and 7 to 9 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience Strong attention to detail with the ability to identify inconsistencies and errors in complex regulatory documents. Proven ability to operate effectively in a collaborative environment requiring coordination, communication, and analytical judgment. Solid understanding of pharmacovigilance principles and global regulatory requirements related to periodic aggregate reporting (e.g., PBRERs, DSURs, PADERs). Proficiency in scientific and technical writing/editing, with an emphasis on quality control and adherence to style guides and templates. Excellent written and verbal communication skills in English, with strong organizational and time management abilities. Demonstrated ability to manage competing priorities and strict deadlines while maintaining high-quality standards. Familiarity with the structure and content of safety reports and the ability to interpret and validate data inputs from multiple contributors. Proficient in Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat, and document management systems (e.g., Veeva Vault, SharePoint). Working knowledge of AI tools and prompt use is a plus, especially for enhancing QC efficiency. Team-oriented approach with the ability to work cross-functionally to support compliance and inspection readiness efforts. Contribution: Ensures Amgen remains in compliance and becomes best in class with regard to periodic aggregate report processes Implements and maintains document standards Responsible for successful tracking of metrics, timelines, and performance indicators for PASR objectives. Preferred Qualifications: Health Care Professional with minimum 2 - 3 years of relevant work experience Including 1 to 2 years of experience in periodic aggregate safety report writing OR Bachelors / Masters degree in Health/Life Sciences with minimum 2 - 3 years of Overall 2 + years of authoring/editing experience in medical writing domain across different therapeutic areas in safety documents including Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR). Experience in preparation of safety documents necessary for national and international regulatory submissions to the US, European Union and other regulatory agencies. Knowledge of Pharmacovigilance regulations for Periodic Aggregate Safety Reports.

Band : TBD Position Overview: Subject Matter Expert PCI Business We are seeking an experienced Subject Matter Expert (SME) in Pharmacovigilance Research to lead drug safety monitoring, regulatory compliance, and risk assessment initiatives. This role requires deep expertise in pharmacovigilance regulations, adverse event management, and clinical trial safety assessments. The SME will provide strategic guidance, ensure compliance with global regulatory standards, and support process optimization within pharmaceutical and biotech industries. Key Responsibilities Establish and maintain production and quality control protocols for data collection, analysis, and reporting processes Develop and implement standard operating procedures (SOPs) for pharmaceutical and patent research workflows Monitor data accuracy, completeness, and consistency across all research initiatives Conduct regular quality audits and training as needed Maintain detailed documentation of quality metrics, process improvements, and validation activities Present complex analytical results to stakeholders in clear, actionable formats Lead projects while collaborating with different teams and information sources Provide pharmacovigilance expertise in clinical trial safety assessments, serious adverse event (SAE) reporting, and regulatory submissions. Evaluate and recommend the adoption of advanced technologies (e.g., AI for case processing, automation tools, predictive analytics) to streamline pharmacovigilance operations. Business acumen that helps support sales success, ongoing improvements, and relationships with internal and external stakeholders. Required Skills & Qualifications: Education: Bachelor's, Masters, or PhD in Pharmacy, Life Sciences, Medicine, or a related field. Experience: Minimum of 7+ years in pharmacovigilance, drug safety, regulatory affairs, or clinical research. Regulatory Knowledge: Deep understanding of pharmacovigilance regulations (FDA, EMA, ICH-GCP, CIOMS, WHO). Technical Proficiency: Experience with pharmacovigilance databases (e.g., Argus, ArisG, Veeva Vault), data analytics, and safety signal detection tools. Analytical & Problem -Solving Skills: Strong ability to assess risk, interpret complex safety data, and propose strategic solutions. Communication & Leadership : Ability to interact effectively with cross-functional teams, regulatory agencies, and external stakeholders. Skills & Qualifications: Education: Bachelors or Masters degree in Life Sciences (Pharmacy, Biology, Biochemistry, or related field). Advanced degrees (PharmD, PhD, MD) preferred. Experience: Extensive experience (typically 5-10 years) in pharmacovigilance, drug safety, or related roles within the pharmaceutical or biotech industries. Technical Proficiency: Strong understanding of pharmacovigilance systems and software (e.g., Argus, ARISg, Safety Database Management systems). Regulatory Knowledge: Deep understanding of global pharmacovigilance regulations, clinical safety practices, and reporting requirements. Analytical & Problem-Solving Skills: Ability to analyze complex safety data and develop evidence-based recommendations. Communication & Interpersonal Skills: Excellent verbal and written communication abilities to collaborate effectively with cross-functional teams, regulatory bodies, and external stakeholders. Why join us? Opportunity to contribute to business growth of IDS while working closely with MD Being a face of MDO for the external stakeholders Competitive compensation package with performance-based incentives and opportunities for career advancement. Dynamic and collaborative work culture that values innovation, integrity, and excellence. Chance to make a meaningful impact by building a business for IDS, client delight, and business growth.