Drug Safety Specialist - GPV

SGS_JOB_2321

Scientific
Remote
Pharmacovigilance
PV Regulatory Requirements
ICSR Processing
ARGUS Safety Database
Experience with Word
Excel
PowerPoint
Microsoft Teams and SharePoint
Case Processing.

Contract - 12 Months

The Data Assurance Associate (GPV) plays a vital role in ensuring the accuracy, compliance, and quality of case processing activities within Pharmacovigilance. This role involves active communication with internal teams, external partners, and vendors to address case-related queries, oversee case corrections, and support training initiatives. The associate will contribute to maintaining the highest standards in pharmacovigilance operations while driving process improvements and compliance with global regulatory requirements.

Job Responsibilities:

  • Communicates with internal and external parties on case content and replies to case-related queries.
  • Makes decisions on case processing matters for prioritization, FU significance, seriousness, listedness, coding queries, etc.
  • Initiates case corrections, as needed.
  • Approves case corrections, as needed
  • Supports late case investigations by PV COPE team
  • Performs clinical open query investigations
  • Provides support for the creation/update of training materials in collaboration with the Data Assurance Manager and PV Training team.
  • Assists in facilitating finalized training sessions (PV processes and systems) for vendors and relevant case processing staff in collaboration with the Data Assurance Manager and PV Training team.
  • Provides support to global Data Assurance teams and other internal departments, as appropriate

Skills:

  • 5+ years relevant experience within Pharmacovigilance
  • Knowledge and understanding of PV regulatory requirements and ICSR processing procedures globally and in America’s region
  • Has the ability to recommend enhancements to internal policies, processes and procedures based on new requirements, legislation, etc.
  • Present solutions to problems that require the regular use of creativity and ingenuity, while safeguarding Client’s compliance.
  • Ensures case processing and case quality are maintained at highest standards at all times
  • Strong interpersonal skills and multi-cultural /intercultural awareness; able to develop effective relationships through collaboration.
  • Good communication skills in English (written and spoken)
  • Ability to work independently in seeking materials needed for completing daily tasks.
  • Ability to work in a fast-paced environment.
  • Working knowledge of ARGUS safety database
  • Experience with Word, Excel, PowerPoint, Microsoft Teams and SharePoint sites
  • Experience with working from home

Education/Experience:

  • BS/MS degree in life sciences or equivalent (RN preferred)

Related Jobs

Biotechnologist Associate

Scientific
 New Hampshire
12 Months

Location: Portsmouth NH. Looking for a candidate with science degree and some manufacturing experience

GMP
cGMP
lab work

USA - Quality Control Testing Technician - I - USD

Scientific
 Massachusetts
12 months Contract

This position for employment is in the Andover Quality Control Microbiology Laboratory working first shift supporting Laboratory operations Monday through Friday with occasional weekend and holiday coverage. The candidate should be flexible to support both assays performed in the Laboratory, as well as office-based work as needed to support the business. Non-Standard Work Schedule, Travel Or Environment Requirements Some rotational weekend and Holiday coverage is required to support the commercial manufacturing schedule. Adhere to safe work practices and procedures, including aseptic gowning procedures

Quality Control
Testing
Technician

QC Microbiology, Analyst I

Scientific
 Massachusetts
06 Months + (highest possibilities of contract extension)

Location: - Westborough, MA 01581 (On-site) The primary purpose of the Analyst I position is to Support Quality Control Microbiological testing of drug substances, raw materials and process intermediates in support of clinical development and commercial programs under cGMP and GLP guidelines, address excursions and conduct investigations.

lab testing data
logbooks
QC analysis

QC Specialist II

Scientific
 New Hampshire
12 months

Location (mandatory): Portsmouth NH USA 03801 Small Description: The QC Specialist II will join the Quality Control department and assist with technical transfer activities, contributing to the testing and analysis of in-process samples, final product testing, and stability studies. This role requires familiarity with GMP (Good Manufacturing Practices) systems, quality records, and testing methodologies. The individual will work collaboratively to complete complex tasks while ensuring adherence to industry regulations, contributing to method transfers, instrument qualifications, and validation activities.

QC
Capa
investigation

Food Product Manager/Food Product Evaluator II

Scientific
 California
$45 - $46
06 Months (possible extension)

Location (mandatory): Pleasanton, CA 94588 The Product Manager / Product Evaluator II supports food product development by managing product samples, documentation, testing, and evaluations across multiple categories. This role plays a key part in new product demonstrations, sensory evaluations, and finished product specifications while ensuring food safety, quality, and accurate reporting—enabling product development teams to focus on strategic initiatives.

Food Product Development & Evaluation
New Product Development (NPD) Support
Food Sample Management & Inventory Control
Sensory / Organoleptic Evaluation
Product Testing (pH
Viscosity
Texture Analysis)
Food Safety
Microbiology & GMP Practices
Finished Product Specifications & Documentation

Scientist I (Scientific)

Scientific
 Massachusetts
12 months

Location:- Cambridge, MA 02141 (Onsite) Work Schedule: Generally, Monday to Friday 08 Am to 05 Pm EST (slight flexibility in hours) potential weekends (max 40 hrs)

study design
data collection

QC Analyst I

Scientific
 California
27.93/HR
06 months

Location (mandatory): Vacaville California With limited supervision, QC Associate I, is responsible for the performance of direct materials testing in accordance with cGMP regulations. These duties include execution of laboratory testing, trend analysis, documentation review, support of discrepancies (OOS, OOT, OOE) and other laboratory support activities. In conjunction with Quality Control leadership, the QC Associate II works to meet departmental and organizational goals.

laboratory testing
trend analysis
documentation review
cGMP regulations

Lab Manager

Scientific
 Massachusetts
12 Months + (Highest Possibilities of Contract Extension)

Location : Cambridge, MA 02141. The CMC Synthetics Platform within the Client R&D organization is responsible for the process development of small molecule drug substances undergoing clinical studies. We are seeking a hands-on laboratory manager with excellent organizational skills to support our activities. The person will provide services to Client at the Cambridge Crossing (CX), Cambridge, MA site. • Provide on-site service to the Client for both laboratory functions and laboratory equipment and instrumentation maintenance and upkeep • Perform experimental protocols to support the Client’s technology platforms • Ensure compliance with health and safety teams and training as required for Client lab operations • Support inventory management, purchasing, and shipping of chemical compounds and laboratory supplies

Lab Manager
Laboratory Manager
Lab Operations
Laboratory Operations
Lab Supervisor
Laboratory Specialist
HPLC
UPLC
liquid chromatography
chemistry

USA - Research Associate - I - USD

Scientific
 California
$28.00 - $31.00
09 months Contract

Location - 11202 El Camino Real San Diego CA USA 92131 The Structural Biology and Protein Sciences group is seeking a highly motivated contractor to support recombinant protein production efforts, primarily utilizing insect cell expression systems. The successful candidate will be responsible for maintaining eukaryotic cell cultures, generating and managing high-titer baculovirus stocks, and performing multi-liter scale protein expression and harvest workflows. Additional responsibilities include executing plate-based expression and purification profiling to enable rapid screening of construct and condition variants. This role requires strong organizational skills, attention to detail, and the ability to operate efficiently in a fast-paced research environment.

quality-control baculovirus stocks
record management
logo

At SGS Consulting, we go beyond resume-job matches, creating meaningful connections and pathways for individuals to thrive in defining careers.


© 2026 All rights reserved.
logologologologo