Safety Specialist I

2 days ago

Bengaluru, Karnataka, India Precision for Medicine Full time ₹ 6,00,000 - ₹ 8,00,000 per year

Position Summary:

The Safety Specialist I is an integral part of the safety team at Precision and performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs.

Essential functions of the job include but are not limited to:

  • Process ICSRs according to Standard Operating Procedures (SOPs) and project/program- specific safety plans
  • Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability
  • Enters data into Argus Safety Database
  • Code events, medical history, concomitant medications and tests.
  • Draft case narratives
  • Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved
  • Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements
  • Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases
  • Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects
  • Participate in audits/inspections as required
  • Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
  • Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process
  • Attends Department meetings
  • Participates in project specific teleconferences/meetings as required
  • Other duties assigned by management

Qualifications:

Minimum Required:

  • Minimum 2 years of experience in clinical trial drug safety in the Pharma/CRO industry
  • Bachelor's or first-level Degree in Pharmacy or Nursing preferred, but other Life Science, or other health-related field, or equivalent qualification.  Immuno-oncology and Advanced Therapy Medicinal Products experience a plus.
  • Experience with Oracle Argus Safety Database
  • Working knowledge of MedDRA and WHODrug
  • Working knowledge of FDA safety regulations, EMA.MHRA and other ICH guidelines, and global safety regulations

Preferred:

  • Early phase oncology clinical trial experience

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. 

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

  • Safety Specialist

    2 weeks ago

    Bengaluru, Karnataka, India Chevron Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    About the position: The Safety Specialist is responsible for providing technical support and analysis of Control of Work (CoW) activities supporting enterprise-wide activities including the development and implementation of safe work practices and standards. The Safety Specialist reports to the Workforce Safey Team Lead in the Chevron Engine in Bengaluru,...

  • Safety Engineer Civil

    3 weeks ago

    Bengaluru, Karnataka, India GMS ELEGANT BUILDERS (I) PVT LTD Full time

    Job Title: Safety Head – Civil Engineering ProjectsLocation: Tamil Nadu (Candidates from Tamil Nadu only) Industry: Civil Engineering / Construction (Buildings, Apartments, Infrastructure) Experience: 10+ years in Safety Management within Civil / Construction projectsJob Summary:Responsible for planning, implementing, and overseeing safety policies and...

  • Drug Safety Medical Specialist

    17 hours ago

    Bengaluru, Karnataka, India beBeeSpecialist Full time ₹ 1,80,00,000 - ₹ 2,50,00,000

    Pharmacovigilance SpecialistAs a Pharmacovigilance Specialist, you will play a critical role in ensuring the safety of patients by reviewing individual case safety reports (ICSRs) for accuracy and medical relevance.Comprehensive medical review of ICSR's to identify potential serious adverse events (SAEs)Second-level triaging of non-serious cases to identify...

  • System Specialist I

    3 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Department - Quality Facilities ITAre you experienced in managing IT systems and looking for a new challenge Do you have a strong background in compliance strategy and documentation We are seeking a talented System Specialist to join our Quality Facilities IT department at Novo Nordisk If you are ready to take on a key role in managing our Corporate...

  • Associate I, Patient Safety

    6 days ago

    Bengaluru, Karnataka, India Alcon Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Case Processing:· Process case files according to Standard Operating Procedures (SOP).· Work with affiliate offices to ensure required dataset has been received/requested.· Re-assess the data, ensure accurate product selection and assign required event code(s) in the system.· Complete initial and follow-up reporting assessments as information is received...

  • Tuv Functional Safety Engineer

    4 weeks ago

    Bengaluru, Karnataka, India Quest Global Full time

    We are accepting Job Applications : Please submit updated CV - Email : chetan.sp@quest-global.com;sunil.chandran@quest-global.com Experience : 10 - 20 Years Instrumentation and Controls Engineer with 8+ years' experience in Oil and Gas Industry (Upstream Oil and Gas / Downstream Refinery Units) Conducts Hazard & Risk Assessment, allocation of safety...

  • Senior Environmental Health and Safety Specialist

    19 hours ago

    Bengaluru, Karnataka, India beBeeEnvironmentalHealthSafety Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Job Title: Senior Environmental Health and Safety SpecialistWe are seeking a seasoned expert to lead the implementation of end-to-end environmental, health, and safety solutions utilizing SAP technology.Key ResponsibilitiesDesign and execute comprehensive SAP EHS strategies, focusing on Product Safety modules including Specification Master, Phrase Library,...

  • Procurement Specialist

    17 hours ago

    Bengaluru, Karnataka, India beBeeProcurement Full time ₹ 80,00,000 - ₹ 2,00,00,000

    Procurement Specialist OpportunityWe are seeking a highly skilled Procurement Specialist to manage the procurement of refurbished components, spare parts, and devices for our operations.The ideal candidate will have a strong understanding of vendor management, negotiation, and the supply chain ecosystem.Key Responsibilities:Identify and onboard new vendors...

  • Electrical Safety Specialist

    23 hours ago

    Bengaluru, Karnataka, India beBeeElectronics Full time ₹ 8,00,000 - ₹ 14,50,000

    Job OverviewAbout the RoleWe are seeking a highly skilled Functional Safety Expert to join our team.This is an exciting opportunity for a seasoned professional in electrical/electronic engineering to leverage their expertise in system development, safety analysis, and power electronics to drive success.The ideal candidate will have a proven track record of...

  • TUV Functional Safety Engineer

    4 weeks ago

    Bengaluru, Karnataka, India Quest Global Full time

    We are accepting Job Applications : Please submit updated CV - Email : ; Experience : 10 - 20 Years Instrumentation and Controls Engineer with 8+ years' experience in Oil and Gas Industry (Upstream Oil and Gas / Downstream Refinery Units) Conducts Hazard & Risk Assessment, allocation of safety requirements to the SIS, functional safety requirements...