-
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 ...
-
Safety Specialist
2 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. · ...
-
Health, Safety, Environment Specialist
4 days 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 ...
-
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 ...
-
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 & ...
-
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: $113, ,000 Annually** · **Requirements**: · - Masters or Bachelors Degree · - Experience within Qu ...
-
Specialist for Occupational Safety
2 weeks ago
Spectrum Dynamics Westwood, United StatesTogether with you into the future. · Occupational Safety Specialist (m/f/d) at Westwood · Westwood is known for its exceptional service and draws on 20 years of experience. We offer a wide range of chemical-related and service-oriented services and accompany our clients on thei ...
-
Quality and Patient Safety Specialist
2 weeks ago
VBeyond Healthcare Boston, United States**Job Title**:Quality and Patient Safety Specialist (Direct Hire) · **Duration**:Full Time Permanent · **Shift**:The shift will be discussed during the interview. · **Location**: Boston, MA · **Salary Range**:$ to $ Annually · **Requirements**: · - Master's or bachelor's Degree · ...
-
Drug Safety Specialist
1 week 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 ...
-
Drug Safety Specialist
2 weeks ago
GForce Life Sciences Waltham, United StatesDuration: 6-month contract · Location: Onsite in Waltham - 3 days onsite, 2 days wfh · Start 2 weeks from an offer · Responsibilities: · Responsible for the processing adverse event reports that include but not limited to the receipt, evaluation, reviewing and reporting of adver ...
-
Drug Safety Specialist
2 days ago
Beacon Hill Life Sciences - Boston Waltham, United StatesJob Description · Job DescriptionCase Processing (CT/ PM) - 50% · 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 accord ...
-
Safety, Health and Environmental Specialist
3 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 ...
-
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 ...
-
Safety and Support Specialist, Full-time
1 day 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 ...
-
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 ...
-
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 ...
-
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 ...
-
Alkermes Waltham, United States Full timeSummary · 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 regula ...
-
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 ...
-
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 ...
Hybrid Drug Safety Specialist - Waltham, United States - Staffmark Group
Description
Hybrid- 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 reporting of adverse event information for marketed and investigational products in accordance with ICH guidelines and applicable regulatory requirements including the FDA, SOPs, and applicable licensing or partnership agreements.
Track cases from receipt to closure and work with clinical, regulatory, and contract research organizations (CROs) to ensure that all post-market and clinical safety pharmacovigilance activities are performed across ongoing projects independently.
Perform verification of safety data and will utilize clinical judgement in coding of verbatim adverse events, medical history, and medications.
Actively obtains follow-up through event resolution. Performs SAE reconciliation, ensuring completeness and closure of cases in a timely fashion.
Performs continuous quality improvement initiatives to ensure data consistency across products and a high level of data quality.
Contributes in the conduct of ongoing safety surveillance for marketed and investigational products. Assist with the identification and evaluation of events of special interests as well as aggregate data review.
Vendor Management Coordination - 25%
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.
Basic Qualifications:
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, demonstrate general medical and pharmacology knowledge
Preferred Qualifications:
Experience processing Oncology cases
Have demonstrated knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance related to pharmacovigilance and Good Clinical Practices
Ability to make clinical decisions and formulate appropriate queries based on sound medical knowledge
Competence with commercial safety application databases such as Clintrace, ArisG or Argus. Knowledge of clinical trial database (e.g., Trailmaster) is a plus
Ability to work effectively as an individual contributor and as project team safety representative
Is proactive, demonstrate ability to independently identify problems and effectively offer solutions
The ability to work independently and multi-task with attention to detail,
Excellent interpersonal, communication, and personal organization skills; ability to prioritize workload and work effectively, sometimes within resource constraints
After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities.