Current jobs related to Drug Safety Senior Specialist - Waltham - Peak Performers
-
Drug Safety Manager
3 weeks ago
Waltham, United States Talent Groups Full timeNeed Independent candidates only (USC/ GC). The Senior Manager, PV Operations will support global drug safety activities across clinical development and post-marketing programs. Minimum 5 years of biotech/pharma experience, including 3+ years in drug safety/ Pharmacovigilance. Experience with CRO/vendor oversight, global PV operations, and strong knowledge...
-
Senior Global Drug Safety
3 weeks ago
Waltham, United States Talent Groups Full timeA biotechnology company based in Waltham, MA, is looking for a Senior Manager in PV Operations to lead global drug safety activities. The ideal candidate will have over 5 years' experience in biotech or pharma, with a focus on drug safety and vendor oversight. Responsibilities include monitoring vendor performance and ensuring compliance with regulatory...
-
Drug Safety
3 weeks ago
Waltham, United States Alkermes Full timeDrug Safety & Pharmacovigilance Systems and Analytics LeadThe Global Safety System Analyst role is critical for supporting, analyzing, and optimizing pharmacovigilance and drug safety systems. The candidate will leverage Oracle SQL, Snowflake, Python, Tableau, and Spotfire expertise to ensure robust data management, analysis, visualization, and reporting....
-
Waltham, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and...
-
Waltham, Massachusetts, United States Dyne Therapeutics Full time $217,280 - $266,750Company Overview:Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and...
-
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and...
-
Senior/Principal Scientist, Anti-Drug Conjugate
2 weeks ago
Waltham, Massachusetts, United States Crescent Biopharma , Inc. Full timeAbout UsCrescent Biopharma's vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company's pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance...
-
Associate Director, Drug Safety Operations
3 days ago
Waltham, United States Talent Groups Full timeJob DescriptionWe are seeking an Associate Director, PV Systems to manage and enhance its global Argus Safety platform and PV reporting systems. This role will lead end-to-end safety systems activities including configuration, validation, E2B reporting, system integrations, and vendor collaboration. The position partners closely with PV Operations,...
-
Retail Health and Safety Specialist
1 week ago
Waltham, United States Global Partners Full timeRetail Health And Safety SpecialistWorking in collaboration with the Retail Health and Safety Manager, the Retail Health and Safety Specialist will develop and manage health and safety communications necessary to ensure company standards are understood and implemented. The specialist will promote hazard awareness and mitigation through timely communications...
-
Construction Safety Oversight Specialists
4 weeks ago
Waltham, United States ERM Full timeConstruction Safety Oversight Specialists (Field Based) Join to apply for the Construction Safety Oversight Specialists (Field Based) role at ERM ERM is hiring experienced consulting Construction Safety Oversight Specialists in the US. In this critical role, you will be responsible for providing on-site observation of construction activities from an EHS...
Drug Safety Senior Specialist
4 weeks ago
OverviewPeak Performers has partnered with a pharmaceutical company to assist in their search for a hybrid Drug Safety Senior Specialist in Waltham, MA. In this position, you will participate in protocol design, safety CRF development, safety monitoring plan, support of DSMB activities, coding review as well as SAE reconciliation activities.ResponsibilitiesCoordinate and document ongoing safety surveillance activities with the safety physician. Activities will include safety data review, signal validations, signal evaluationsLead aggregate report (PSUR/PADER/DSUR) activities, including vendor oversight and project management, database requests, data analysis, report authoring, and quality checks.Manage literature review plan for assigned product(s) and provide feedback to vendor on routine literature surveillance activitiesIn conjunction with the safety physician, prepare materials for routine and ad hoc Safety Governance meetings (product- and leadership-level meetings).Coordinate responses for ad hoc safety queries (eg, health authority requests, NISS, or health hazard evaluations) in conjunction with the safety physician and cross functional team members, as needed.Perform safety data analyses, draft query responses, and prepare documents for cross functional review and finalization.Represent safety (with safety physician) and cross functional product meetingsSupport activities relevant to investigational program including (but not limited to):Routine/ad hoc updates to safety content of Investigator Brochure (IB), safety content of protocols, CRFs, ICFsRoutine DSMB presentationsOngoing data review, including lab and AE data reviewMaintain strong working knowledge of relevant regulations associated with the above activities.Contributes to initiatives for process improvement and cross-product process consistency.QualificationsMinimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience, including 3 years of experience in drug safety serving in a PV Scientist role.Demonstrated experience in analysis and interpretation of medical and scientific data and excellent verbal and written skills.Demonstrated ability to work effectively either independently or collaboratively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleaguesDemonstrated ability to prioritize multiple assignments and proactively identify solutions, as neededStrong organizational, project management and leadership skills: Leads and conducts (independently and/or collaboratively) all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.Oversees and mentors less experienced PV Scientist staff.Demonstrated clinical judgment to interpret case information.Familiarity with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.Strong knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects), MedDRA, and Argus Safety SystemOpportunity DetailsRate: $73.00/hourW2 ContractWorksite Location: Waltham, MAHybrid6 month contractThe Peak Performers differenceExcellent medical health, dental & vision insurance at 60 daysOur employees may choose to participate in a 403(b) retirement planQualified applicants with chronic medical conditions and/or disabilities receive priority placementWe pay weekly through direct depositIn business since 1994 and thousands of job placementsAll employment offers are contingent on the successful completion of a pre-employment criminal background check, in compliance with all applicable federal and state laws. Applicants for employment with Peak Performers must possess work authorization that does not require sponsorship for a visa now or in the future. Peak Performers is an equal opportunity employer and will consider all applicants without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. Peak Performers does not accept unsolicited resumes from headhunters, recruitment agencies or fee-based recruitment services. #J-18808-Ljbffr
