Safety Specialist I

2 days ago

Bengaluru, Karnataka, India Precision for Medicine Full time ₹ 9,00,000 - ₹ 12,00,000 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 I

    2 days ago

    Bengaluru, Karnataka, India Precision Value & Health Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Safety Specialist I -Location: Bangalore Karnataka IndiaBangalore Karnataka IndiaJob Type: Regular Full-timeDivision: Precision for MedicineBusiness Unit: Clinical SolutionsRequisition Number: 6002Position SummaryThe Safety Specialist I is an integral part of the safety team at Precision and performs all aspects of the collection, processing, and reporting...

  • Safety Specialist I

    7 days ago

    Bengaluru, Karnataka, India Precision for Medicine Full time ₹ 9,00,000 - ₹ 12,00,000 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...

  • Client Services Support Specialist I

    7 days ago

    Bengaluru, Karnataka, India WHITE HORSE MANPOWER CONSULTANCY (P) LTD Full time ₹ 32,40,000 - ₹ 35,00,000 per year

    Client Services Support Specialist I / II | International Inbound Voice | 14 Yrs | Up to 35K | Night Shift | Immediate Joiners Job Description Client Services Support Specialist I / II We are hiring Client Services Support Specialists (Levels I & II) with international inbound voice process experience. This is a 100% work-from-office role for...

  • Environment, Health and Safety Manager

    2 days ago

    Bengaluru, Karnataka, India Frutta - Corporate Refreshment & Experience Specialist Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Frutta is South India's most preferred one-stop corporate refreshment & experience partner. We aim to do the same by providing an exciting assortment of refreshments and events by seamlessly integrating technology to provide unparalleled hospitality. With an extensive network of top-tier vendors spanning from culinary delights to event management, we deliver...

  • I&E Facility Engineer

    5 hours ago

    Bengaluru, Karnataka, India Chevron Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    About The PositionInstrumentation and Electrical Facility Engineer is a member of Chevron's ENGINE Facilities Designs Engineering team providing instrumentation, controls, and electrical designs support to Chevron's Refining and Liquified Natural Gas (LNG) assets. This role is responsible for supporting the troubleshooting, analysis and development of I&E...

  • Commis I

    9 hours ago

    Bengaluru, Karnataka, India Naukri Hospitality Jobs Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    We are looking for a highly skilled and experienced Commis I - Tandoor to join our team in the hospitality industry. The ideal candidate will have a strong background in cooking and experience working with tandoors.Roles and ResponsibilityPrepare and cook a variety of dishes using tandoors, including pizzas, bread, and other Italian cuisine.Maintain high...

  • Client Services Support Specialist I

    2 weeks ago

    Bengaluru, Karnataka, India White Horse Manpower Consultancy Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Client Services Support Specialists (Levels I & II) with international inbound voice process experienceThis is a 100% work-from-office role for candidates with strong communication skills, customer service mindset, &willingness to work in US shifts Required Candidate profileInternational inbound voice calls resolve queriesExcellent customer service with...

  • Safety Surveillance Adviser I

    4 days ago

    Bengaluru, Karnataka, India Novo Nordisk Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year

    Job Description Department: Global Safety - Global Business Services (GS-GBS). Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your...

  • Safety Surveillance Adviser I

    2 days ago

    Bengaluru, Karnataka, India Novo Nordisk Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year

    Job Description Department: Global Safety - Global Business Services (GS-GBS). Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your...

  • Digital Production Specialist I

    4 weeks ago

    Bengaluru, Karnataka, India Kaplan Full time

    Job Title Digital Production Specialist I Hybrid For more than 80 years Kaplan has been a trailblazer in education and professional advancement We are a global company at the intersection of education and technology focused on collaboration innovation and creativity to deliver a best in class educational experience and make Kaplan a great place to work...