Pharmacovigilance Safety Scientist

1 month ago

Atlanta, United States ProPharma Group Full time

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Pharmacovigilance (PV) Safety Scientist The PV Safety Scientist supports the activities in the Benefit Risk group by ensuring that day to day operational activities are completed. The PV Safety Scientist is expected to be professional and diligent and liaises with Director and management group members within the team on any issues, as well as coordinate the work with the Senior PV Safety Scientists. The PV Safety Scientist is also expected to lead by example and ensures quality standards are upheld within the company. Essential Functions: Coordination and performance of Literature screening activities (set-up of literature screening strategies, literature databases' activities, assessment of the results), acting as SME. Coordination and performance of preparation, review, and submission of Aggregate Reports (PSUR/ DSUR/ PADER/ ACO), acting as SME, (as applicable). Coordination and performance regarding Authoring/ updating of Risk Management Plans (RMPs), acting as SME (as applicable). Compilation and presentation of submission metrics for aggregate reports. Coordination and authoring of signal assessment reports, acting as SME. Assists with scheduling and forecasting of aggregate reports and signal management activities. Communication with internal and external stakeholders. Training/mentoring new team members. Participates in internal/external audits/inspections as SME, if required, assisting QMS team with deviations/CAPAs, as assigned. Supporting Project Managers, if required. Assisting with any other ad-hoc requests, as necessary. In coordination with the management group, assuming the responsibility for: Maintenance of Company Core Data Sheets (CCDSs). Assistance with a compilation of safety variations, if required. Coordination and responding to regulatory authority queries. Necessary Skills and Abilities: A thorough knowledge foundation in pharmacovigilance, ideally having clinical experience in various aspects of pharmacovigilance. Significant experience in literature screening activities. Significant experience authoring and reviewing aggregate reports, including PSURs, PADERs, DSURs in line with applicable templates and guidance. Significant knowledge of signal detection methodologies and modalities, and experience in authoring signal assessment reports. Preferably: Experience managing CCDSs, including the creation and update of CCDSs. Knowledge of regulatory safety variation processes. Knowledge of other pharmacovigilance processes, ability to author/update SOPs or Working instructions, to identify and author deviations/CAPAs. Knowledge of audit/inspection process and participative experience. Demonstrable ability to analyze and quantify large volumes of data concisely and scientifically, in keeping with regulatory deadlines. Keen organizational skills, with the ability to manage a dynamic workload effectively. Sound communication skills. Educational Requirements: Life science degree. Experience Requirements: 3 years' experience in Pharmacovigilance, preferably medical writing roles. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*** #J-18808-Ljbffr

  • Pharmacovigilance Safety Specialist

    1 week ago

    Atlanta, Georgia, United States ProPharma Group Full time

    About ProPharma Group:For over two decades, ProPharma has been dedicated to enhancing patient health and wellness by offering expert guidance that empowers organizations in the biotech, medical device, and pharmaceutical sectors to confidently pursue scientific advancements and launch innovative therapies. As the largest Research Consulting Organization...

  • Laboratory Scientist

    1 day ago

    Atlanta, Georgia, United States HealthTrackRX Full time

    Job SummaryHealthTrackRX is seeking a highly skilled Clinical Laboratory Scientist to join our team in the Analytical Operations department. As a Clinical Laboratory Scientist, you will play a critical role in ensuring the accuracy and quality of infectious disease testing.Key ResponsibilitiesPerform sample preparation, DNA extraction, and PCR procedures...

  • Environmental Staff Scientist

    7 days ago

    Atlanta, United States Regenesis Bioremediation Products Full time

    Job DescriptionJob DescriptionJob ResponsibilitiesThe Environmental Staff Scientist will assist in the implementation of turn‐key groundwater and soil remediation designs utilizing our custom designed injection trailers equipped with specialized tanks, pumps, hoses, flow meters, pressure gauges, and injection tooling at project sites around the United...

  • Entry-Level Engineer/Physical Scientist

    21 hours ago

    Atlanta, Georgia, United States Nuclear Regulatory Commission Full time

    Job SummaryWe are seeking highly motivated and talented individuals to join our team as Entry-Level Engineers/Physical Scientists at the Nuclear Regulatory Commission. As a key member of our team, you will play a critical role in ensuring the safe and secure operation of nuclear power plants and facilities.Key ResponsibilitiesConduct technical reviews and...

  • Clinical Laboratory Scientist

    1 month ago

    Atlanta, United States HealthTrackRX Full time

    Job DescriptionJob DescriptionJOB DESCRIPTIONClinical Laboratory ScientistDepartment: Analytical OperationsFLSA Status: Non- ExemptReports To: Technical SupervisorManages People: NoExperience: 0-1 years of testing experience in high complexity testingLevel of Supervision: Directed in all aspects of the work.Job Summary:• The Clinical Laboratory Scientist I...

  • Environmental Scientist

    1 day ago

    Atlanta, Georgia, United States Burns & McDonnell Full time

    **Job Summary**Burns & McDonnell, a leading environmental consulting firm, is seeking a highly skilled Environmental Scientist - Permitting Specialist to join our team in the Charlotte, NC, or Atlanta, GA, office. As a 100% employee-owned firm, we offer the opportunity to exercise your entrepreneurial spirit and develop professionally within a growing and...

  • Senior Staff Research Scientist IX: Computational Chemist

    1 month ago

    Atlanta, United States Recooty Full time

    Senior Staff Research Scientist IX: Computational Chemist - Hexagon Lavish® Home Job Description Senior Staff Research Scientist IX: Computational Chemist Job Description Company Description Hexagon Lavish® is an antiartificial scientific R&D startup based in Atlanta, Georgia that specializes in performance of immediate materials characterization and...

  • Medical Laboratory Scientist I

    4 weeks ago

    Atlanta, United States Quest Diagnostics Incorporated Full time

    Medical Laboratory Scientist I - Atlanta, GA - Monday-Friday 10:00pm-6:30am (Rotational Weekends) (Microbiology Department) $10,000 Sign On Bonus - External Candidates Only Are you intrigued by the science of the human body? Curious about state-of-the-art laboratory instrumentation? Looking to join a Fortune 500 company leading the world in providing...

  • Graduate Intern, Data Scientist

    3 weeks ago

    ATLANTA, Georgia, United States Delta Airlines Full time

    Graduate Intern, Data Scientist (Spring, 2025) United States, Georgia, Atlanta Ops Control 23-Aug-2024 Ref #: 25925 LinkedIn Tag: #LI-MP2 How you'll help us Keep Climbing (overview & key responsibilities) Delta Air Lines connects the world by flying 180 million customers to 300+ destinations every year. On the predictive pod of the Operations...

  • Staff Research Scientist III: Scientific Programmer I

    1 month ago

    Atlanta, United States Recooty Full time

    Staff Research Scientist III: Scientific Programmer I - Hexagon Lavish® Home Job Description Staff Research Scientist III: Scientific Programmer I Job Description Company Description Hexagon Lavish® is an antiartificial scientific R&D startup based in Atlanta, Georgia that specializes in performance of immediate materials characterization and information...

  • Scientist I/II, Drug Delivery/Immunology

    4 weeks ago

    Atlanta, United States Piezo Therapeutics Full time

    Piezo Therapeutics has an opening for a Scientist I, Immunology to play a key role in experimental studies to transform the delivery of nucleic acid medicines (mRNA, DNA) to enable improved safety, affordability, and scalability. This scientist position will be within the broader R&D team at Piezo, performing basic and translational research at the...

  • Scientist I/II, Drug Delivery/Immunology

    1 month ago

    Atlanta, United States Piezo Therapeutics Full time

    Piezo Therapeutics has an opening for a Scientist I, Immunology to play a key role in experimental studies to transform the delivery of nucleic acid medicines (mRNA, DNA) to enable improved safety, affordability, and scalability. This scientist position will be within the broader R&D team at Piezo, performing basic and translational research at the...

  • Scientist I/II, Drug Delivery/Immunology

    4 days ago

    atlanta, United States Piezo Therapeutics Full time

    Piezo Therapeutics has an opening for a Scientist I, Immunology to play a key role in experimental studies to transform the delivery of nucleic acid medicines (mRNA, DNA) to enable improved safety, affordability, and scalability. This scientist position will be within the broader R&D team at Piezo, performing basic and translational research at the...

  • Scientist I/II, Drug Delivery/Immunology

    5 days ago

    atlanta, United States Piezo Therapeutics Full time

    Piezo Therapeutics has an opening for a Scientist I, Immunology to play a key role in experimental studies to transform the delivery of nucleic acid medicines (mRNA, DNA) to enable improved safety, affordability, and scalability. This scientist position will be within the broader R&D team at Piezo, performing basic and translational research at the...

  • Sr. Operations Research Scientist

    1 month ago

    Atlanta, Georgia, United States Norfolk Southern Corp. Full time

    Norfolk Southern offers a unique opportunity to be part of our proud legacy that spans nearly 200 years. We are a customer-centric, operations-driven team dedicated to advancing safety, serving communities, and driving innovation for tomorrow's rail. As part of Norfolk Southern, you'll join a collaborative team where there are opportunities for growth across...

  • Staff Research Scientist III: Scientific Programmer I

    1 month ago

    Atlanta, United States Hexagon Lavish Full time

    About the job Staff Research Scientist III: Scientific Programmer I Staff Research Scientist III: Scientific Programmer I*Job DetailsHexagon Lavish® is an antiartificial scientific R&D startup based in Atlanta, Georgia that has an opening full-time/permanent position for an experienced Scientific Programmer I who will direct an engaging focus in conducting...

  • Operations Research Scientist

    4 weeks ago

    Atlanta, United States Norfolk Southern Corp. Full time

    Norfolk Southern offers a unique opportunity to be part of our proud legacy that spans nearly 200 years. We are a customer-centric, operations-driven team dedicated to advancing safety, serving communities, and driving innovation for tomorrow's rail.  As part of Norfolk Southern, you’ll join a collaborative team where there are opportunities for growth...

  • Operations Research Scientist

    4 weeks ago

    Atlanta, Georgia, United States Norfolk Southern Corp. Full time

    Norfolk Southern offers a unique opportunity to be part of our proud legacy that spans nearly 200 years. We are a customer-centric, operations-driven team dedicated to advancing safety, serving communities, and driving innovation for tomorrow's rail. As part of Norfolk Southern, you'll join a collaborative team where there are opportunities for growth across...

  • Lead Computational Chemist

    1 week ago

    Atlanta, Georgia, United States Recooty Full time

    Position Title: Lead Computational Chemist - Senior Research ScientistCompany Overview:Recooty is an innovative scientific research and development organization that focuses on advanced materials characterization and the development of information retrieval techniques. Our flagship product, PIR: Premier Information Retrieval, enhances the capabilities of...

  • Senior Data Scientist

    3 weeks ago

    Atlanta, United States Kimberly-Clark Full time

    Description You’re not the person who will settle for just any role. Neither are we. Because we’re out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a difference. Here, you’ll bring your professional expertise, talent, and drive to building and managing our portfolio of iconic,...