Senior Safety Associate

3 weeks ago


Cambridge, United States Randstad Life Sciences US Full time

Sabr Associate III / Senior Safety Associate III

6 Month Initial Contract

Cambridge, MA (Hybrid possible)

Max PR: $57.58


MUST HAVE - Willingness to work ONSITE in Cambridge, MA +

  • BS in Nursing, Pharmacy, Healthcare or Lifesciences
  • Direct End-to-End Case Processing experience (data entry and quality review)
  • Experience with both Clinical Trial and Post-marketing ICSRs
  • Vendor Workflow Management


SUMMARY

The Senior Safety Associate III will be responsible for supporting Global Case Management with ICSR quality review, controlled document updates and creation, training material edits and creation and associated tasks, and other case processing oversight activities as delegated. The Senior Safety Associate III supports the Case Processing Oversight and ICSR Processes and GCM Systems teams and is responsible for ensuring AE case processing is compliant with regulatory requirements and corporate and departmental procedures.


ROLE

  • Perform quality review of ICSRs
  • Monitor case processing workflow for vendors and escalate cases at risk of missing timelines.
  • Perform review and updates in controlled documents.
  • Recording meeting minutes and team notes.
  • Participate in testing and conference room pilots for Global Safety Database (GSD) upgrade project.
  • Support other tasks as assigned by manager.


Education & Qualifications

  • Bachelor's Degree in nursing, pharmacy, or other health care related profession or life sciences
  • Must have direct experience with end-to-end Case Processing (data entry and quality review) of both Clinical Trial and Post-marketing ICSRs
  • Advanced proficiency in Microsoft Office applications
  • Exceptional organizational skills and attention to detail
  • Ability to successfully and efficiently multi-task
  • Excellent communication skills (written and verbal)
  • Knowledge of common safety database systems
  • Ability to work collaboratively in a team environment


  • Senior Manager, PV

    2 weeks ago


    Cambridge, United States The Steely Group Full time

    Job DescriptionJob Description*HYBRID OPPORTUNITY, ON-SITE ROUGHLY 3 AYS A WEEK DURING CORE HOURS* This Senior Manager-level role oversees the effective delivery of and continued evolution of Pharmacovigilance (PV) activities related to the organization’s clinical development programs. The Purpose of this Role:Develops and designs pharmacovigilance...


  • Cambridge, United States Repertoire Immune Medicines Full time

    Job DescriptionJob DescriptionResearch Associate II/Senior Research AssociateProtein Engineering & Molecular SciencesCompany OverviewRepertoire Immune Medicines is a biotechnology company working to unlock and direct the remarkable power of the human immune system to treat cancer, autoimmune disease and infectious disease. The company was founded by Flagship...


  • Cambridge, Massachusetts, United States Biogen Full time

    Job Description What you’ll do: The Associate Medical Director, Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials, identification and investigation of safety signals, management of benefit-risk profile for assigned...


  • Cambridge, United States Randstad Life Sciences US Full time

    Immediate opportunity for an Environmental Health & Safety Specialist II to work with multi-national pharmaceutical company dedicated to pharmaceutical research and vaccine development. The HSE Associate Level Service Provider serves an important and highly visible role helping to ensure that site HSE Management System (HSE-MS) requirements are appropriately...


  • Cambridge, United States Randstad Life Sciences US Full time

    Immediate opportunity for an Environmental Health & Safety Specialist II to work with multi-national pharmaceutical company dedicated to pharmaceutical research and vaccine development. The HSE Associate Level Service Provider serves an important and highly visible role helping to ensure that site HSE Management System (HSE-MS) requirements are appropriately...


  • Cambridge, United States Randstad Life Sciences US Full time

    Immediate opportunity for an Environmental Health & Safety Specialist II to work with multi-national pharmaceutical company dedicated to pharmaceutical research and vaccine development. The HSE Associate Level Service Provider serves an important and highly visible role helping to ensure that site HSE Management System (HSE-MS) requirements are appropriately...


  • Cambridge, United States Mount Auburn Hospital Full time

    **Job Type**:Regular **Time Type**:Full time **Work Shift**:Day (United States of America) **FLSA Status**:Non-Exempt **When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives.** The Public Safety Management Program is followed to ensure a safe and secure environment for patients, staff, and...


  • Cambridge, United States Biogen Full time

    Job Description You could be just the right applicant for this job Read all associated information and make sure to apply.About This RoleThe Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials,...


  • Cambridge, United States The Fountain Group Full time

    Onsite role in Cambridge, MA W2 Candidates onlyManager Updates/Required Skills Must have Safety related experience within Research and Development or Pharma Employers Bachelor's degree Min of 3+ years of experience - direct safety-related experience Senior HSE level experience required Self-driven, ability to take on projects Preferred / Nice to Have...


  • Cambridge, Massachusetts, United States Proclinical Staffing Full time

    Proclinical is seeking a (Senior) Research Associate, Oligonucleotide Chemistry to join a n established research organization in Cambridge, MA, in their oligonucleotide chemistry team. Job Responsibilities:Supporting the synthesis, purification and characterization of oligonucleotidesSupport ordering and general upkeep of RNA synthesizers and other related...


  • Cambridge, Massachusetts, United States Editas Medicine Full time

    At Editas, we are united by a common goal: to deliver groundbreaking therapies to individuals facing severe illnesses with the most critical needs. This ambition propels us to strive for excellence in scientific advancement, enabling us to leverage the potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.We firmly believe that our team members are...


  • Cambridge, United States Delphia Therapeutics Full time

    About Us:Delphia is igniting a new field of therapeutics in hopes to transform the care of cancer patients. Together, we are working to advance first-in-class targeted cancer medicines leveraging Activation Lethality, a new field of cancer biology centered on cancer’s surprising vulnerability to oncogene overactivation. While a bold idea, activation...


  • Cambridge, United States Delphia Therapeutics Full time

    About Us:Delphia is igniting a new field of therapeutics in hopes to transform the care of cancer patients. Together, we are working to advance first-in-class targeted cancer medicines leveraging Activation Lethality, a new field of cancer biology centered on cancer’s surprising vulnerability to oncogene overactivation. While a bold idea, activation...


  • Cambridge, United States Delphia Therapeutics Full time

    About Us:Delphia is igniting a new field of therapeutics in hopes to transform the care of cancer patients. Together, we are working to advance first-in-class targeted cancer medicines leveraging Activation Lethality, a new field of cancer biology centered on cancer’s surprising vulnerability to oncogene overactivation. While a bold idea, activation...


  • Cambridge, United States Agios Pharmaceuticals Full time

    Senior Manager, Medical Coding Who we are: Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient...


  • Cambridge, Massachusetts, United States Philips Full time

    Job TitleSenior Clinical Research AssociateJob DescriptionYour role:Owning the overall study process and adherence to clinical trial procedures by keeping oversight, identifying possible problems/risks, creating mitigation plans, and taking actions or corrective actions using timely communication for daily monitoring and site mgmt.Supporting site...


  • Cambridge, United States Agios Pharmaceuticals Full time

    Senior Manager, Medical CodingWho we are: Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient...


  • Cambridge, Massachusetts, United States Editas Medicine Full time

    As a member of the Process and Analytical Development (PAD) department, the Senior Development Associate contributes to Editas’s efforts to develop safe and effective cellular therapies using CRISPR-based gene editing technologies. Key Responsibilities and Accountabilities: Perform experimentation to develop cellular processes to support gene-edited cell...


  • Cambridge, Massachusetts, United States Editas Medicine Full time

    At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...


  • Cambridge, United States Repare Therapeutics Full time

    Description Reporting to the Vice President of Clinical Development, the Senior Medical Director, is responsible for strategic planning and execution of the assigned clinical program(s) from an end-to-end clinical development perspective, covering phases from IND preparation to approval. You will have experience in the drug development process, particularly...