- Responsible for the processing adverse event reports that include but not limited to the receipt, evaluation, reviewing and reporting of adverse event information for marketed and investigational products in accordance with ICH guidelines and applicable regulatory requirements including the FDA, Alkermes SOPs, and applicable licensing or partnership agreements.
- Acts as a safety representative and facilitator between external reporting sources such as call centers, CROs and investigator sites, interface with internal departments clinical operations, medical information, regulatory affairs, product development, quality assurance, biostatistics, data management, and legal.
- Participate in clinical project teams and other interdepartmental teams supporting clinical studies; reviews and provide comments on study related documents.
- Contributes to the development and writing of industry standard operating procedures and processes for pharmacovigilance activities including writing of the Safety Management Plan for assigned studies to ensure the uniform and timely processing of adverse event reports.
- Assist in responding to queries from health authorities or outside sources; Compiling and supplying as requested, safety information for Regulatory submissions such as IND (Investigational New Drug) safety reports, Annual Safety reports, PSUR, or clinical study reports.
- A clinical degree (e.g., RPh/PharmD, BSN, RN)
- 3-5 years drug safety or clinical safety experience
- Two years clinical experience in a medical setting, demonstrated general medical and pharmacology knowledge
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Safety Specialist
1 week ago
TG Gallagher Waltham, United StatesIf you're a self-starter ready to find and seize opportunity, you'll find the support and resources here to truly thrive. TG Gallagher is the leading provider of mechanical construction and maintenance services throughout New England. · TG Gallagher places great value on health a ...
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Safety Specialist
5 days ago
Mirra Construction Boston, United StatesMirra Co., LLC., has proudly served clients in the civil electric, telecommunication, and natural gas distribution industry. Mirra has been in business for over 70 years, we are continuing to grow and looking to add a Safety Specialist for our Boston and Greater Boston Region. · ...
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Health, Safety, Environment Specialist
1 week ago
Novartis Cambridge, United States**Summary**: · - In alignment with Novartis company strategy to 'Embrace Operational Excellence' and the Novartis Business Services - Real Estate & Facility Services strategy, the purpose of this role is to facilitate the implementation of the Global HSE Strategy by providing tec ...
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Mass General Brigham Somerville, United States**Project Specialist, Ambulatory and Quality Safety Team** · **Come join the Ambulatory and Quality Safety Team at Mass General Brigham and be a part of the world's most powerful force in medicine, where every role is important in changing lives** · **The Role** · The Primary Car ...
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Quality and Patient Safety Specialist
2 weeks ago
JN Salinas Boston, United States** No visa sponsorships supported** · **.** · **JOB DESCRIPTION**: · The Quality & Patient Safety Specialist plays a key role in supporting the development, implementation, management and sustainment of an organization-wide system of quality and safety. Working with the Quality & ...
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Quality and Patient Safety Specialist
2 weeks ago
VBeyond Healthcare Boston, United States**Job Title: Quality and Patient Safety Specialist** · **Duration: Full Time Permanent** · **Shift: Will be discussed during interview** · **Location: Boston, MA** · **Salary Range: $113, ,000 Annually** · **Requirements**: · - Masters or Bachelors Degree · - Experience within Qu ...
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Quality and Patient Safety Specialist
2 weeks ago
VBeyond Healthcare Boston, United States**Job Title**:Quality and Patient Safety Specialist (Direct Hire) · **Duration**:Full Time Permanent · **Shift**:The shift will be discussed during the interview. · **Location**: Boston, MA · **Salary Range**:$ to $ Annually · **Requirements**: · - Master's or bachelor's Degree · ...
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Specialist for Occupational Safety
2 weeks ago
Spectrum Dynamics Westwood, United StatesTogether with you into the future. · Occupational Safety Specialist (m/f/d) at Westwood · Westwood is known for its exceptional service and draws on 20 years of experience. We offer a wide range of chemical-related and service-oriented services and accompany our clients on thei ...
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Drug Safety Specialist
2 weeks ago
Queen Consulting Group, Inc. Waltham, United StatesOur client is seeking a Drug Safety Specialist with clinical experience. The Drug Safety Specialist will have primary responsibility for the following: Case Processing (CT/ PM) - 50% Responsible for the processing adverse event reports that include b Safety Specialist, Drug, Spec ...
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Safety, Health and Environmental Specialist
6 days ago
Edwards Vacuum, LLC - Semiconductor Industry Haverhill, United StatesAre you interested in a career in the **SEMICONDUCTOR INDUSTRY**? Exciting things are happening at Edwards Vacuum where we manufacture a wide variety of industrial vacuum pumps for the semiconductor industry We are experiencing record sales and have moved into a brand-new facilit ...
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Hybrid Drug Safety Specialist
2 weeks ago
Staffmark Group Waltham, United StatesHybrid- 3 days minimum will be onsite. · The Drug Safety Specialist will have primary responsibility for the following: · Case Processing (CT/ PM) - 50% · Responsible for the processing adverse event reports that include but not limited to the receipt, evaluation, reviewing and r ...
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Environmental Health and Safety Specialist
2 weeks ago
The Fountain Group Waltham, United StatesW2 only. No C2C. Contract position: 1 year to start with potential for extension or conversion. Pay: Open, depending on experience. Must-Have chemical or biological safety (Ex: Lab Safety related to Pharma or R&D/ Medical), which is a key component of the job. Manager has stated ...
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Safety and Support Specialist, Full-time
4 days ago
Commonwealth Land Trust, Inc. Boston, United States Full time**Commonwealth Land Trust** · **Safety and Support Specialist** · CATEGORY: Security/Supportive Services · Location: scattered Permanent Supportive Housing sites in Boston, including Beacon Hill, South End, and Dorchester · Hours: Full-time, 40 hours per week. Work primarily duri ...
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VBeyond Healthcare Boston, United States**Job Title**:RN Quality and Patient Safety Specialist (Direct Hire) · **Duration**:Full Time Permanent · **Shift**:The shift will be discussed during the interview. · **Location**: Boston, MA · **Salary Range**:$ to $ Annually · **Requirements**: · - Registered Nurse · - Massach ...
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EHS Construction Safety Specialist
1 day ago
Bytecubit Technologies Andover, United States**Job Title**:EHS Construction Safety Specialist · **Length of Assignment**:1-2 Years · **Location**:Andover, MA · **Rate**:$48/hr - $63/hr (Depending on experience) · - MUST have Lifesciences Building Experience** · - Will be working on of Building and Lab Renovations Projects · ...
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Safety Specialist
1 week ago
QData Cambridge, United States contractRoles & Responsibilities Monitor manage and ensure delivery of projects in a deadline-driven environment. Author Technical SDLC deliverables Technical assistance for testing preparation and implementation of enhancements Contribute to the creation of operational support documenta ...
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Alkermes Waltham, United StatesSummary · Responsible for coordinating and implementing environmental, health and safety (EHS) programs that meet internal requirements as well as compliance with government regulations and/or industry consensus requirements. · Maintains knowledge of current industry and regulato ...
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eTeam Waltham, United StatesJob Title: Environmental Health and Safety Specialist II (Onsite)Location: Waltham, MADuration: 12 MonthsRequirement:Must-Have: Minimum of 5 years of direct safety-related experience Bachelors Degree required Senior HSE level experience required Self-driven, ability to take on pr ...
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eTeam Waltham, United StatesJob Title: Environmental Health and Safety Specialist II (Onsite) · Location: Waltham, MA · Duration: 12 Months · Requirement: · Must-Have:Minimum of 5 years of direct safety-related experience · Bachelors Degree required · Senior HSE level experience required · Self-driven, a ...
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Safety Specialist
1 week ago
Pine Street Inn Boston, MA, United StatesOffice: 444 Harrison Avenue · Position Type: Direct Care · Hours/Shift: Morning - First Shift · Regular Full-time · START YOUR APPLICATION ( · Position 1 -SCHEDULE: 40 hours, full time schedule, Saturday - Tuesday; 9:00am - 7:30pm, may include early mornings, nights and/or we ...
Drug Safety Specialist - Waltham, United States - GForce Life Sciences
Description
Duration: 6-month contract
Location: Onsite in Waltham - 3 days onsite, 2 days wfh
Start 2 weeks from an offer
Responsibilities:
Qualifications:
