Safety Specialist II
1 day ago
Position Summary:
Responsibilities will include, but may not be limited to; safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel.
Essential functions of the job include but are not limited to:
- Interfacing with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems.
- Participate in the assessment and set-up of a safety database to capture SAE data.
- Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures.
- QC of documents and safety reports.
- Preparation and/or review of project‑specific safety reporting plans and medical coding plans.
- Preparation and/or review of safety training materials.
- Provide safety training and oversight for consultants, contractors and/or staff.
- Review and/or draft standard operating procedures and work instructions.
- Assist clients and/or other departmental staff with safety-related reviews and other services.
- Other duties as assigned.
Qualifications:
Minimum Required:
- BA/BS degree
- Minimum 5+ years safety experience
Other Required:
- Health care professional
- Hands on experience with global safety database(s), SAE case processing including narrative writing, and safety reports generation
- Working knowledge of MedDRA and WHODrug
- Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations.
Preferred:
- Nursing or pharmacy degree preferred
- Clinical trial safety experience
- Hands on experience with Argus
- Industry experience in CRO or pharmaceutical company preferred
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 weeks ago
Bengaluru, Karnataka, India Precision Value & Health Full time ₹ 5,00,000 - ₹ 12,00,000 per yearSafety 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...
-
Finacial Administrator Specialist II
2 weeks ago
Bengaluru, Karnataka, India Computershare Full time ₹ 5,00,000 - ₹ 12,00,000 per yearLocation: Hyderabad/Bangalore , India (Hybrid)In this position, you'll be based in the Hyderabad/Bangalore office for a minimum of three days a week, with the flexibility to work from home for some of your working week. If you have a remote location recorded in Fusion this arrangement will continue to be honored if you are successful in your application,...
-
Environment, Health and Safety Manager
2 weeks ago
Bengaluru, Karnataka, India Frutta - Corporate Refreshment & Experience Specialist Full time ₹ 9,00,000 - ₹ 12,00,000 per yearFrutta 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...
-
Safety Specialist I
2 weeks ago
Bengaluru, Karnataka, India Precision for Medicine Full time ₹ 9,00,000 - ₹ 12,00,000 per yearPosition 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...
-
Product Safety Certifier II
2 weeks ago
Bengaluru, Karnataka, India CSA Group Full time ₹ 9,00,000 - ₹ 12,00,000 per yearEmployment StatusRegularTime TypeFull timeBUILDING A WORLD CLASS TEAM STARTS WITH YOUAt the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It's been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500 standards, codes &...
-
Onboarding Specialist II
1 week ago
Bengaluru, Karnataka, India Diligent Corporation Full time ₹ 9,00,000 - ₹ 12,00,000 per yearPosition Overview: As an Onboarding Specialist II, you will work as part of the global Customer Success Team, with the expectation to deliver outstanding experiences during the client's onboarding journey. You will collaborate cross functionally with Customer Success, Marketing, Sales, and Product and own the critical early phase of the client lifecycle....
-
Certifier II
2 weeks ago
Bengaluru, Karnataka, India CSA Group Full time ₹ 1,04,000 - ₹ 1,30,878 per yearEmployment Status:RegularTime Type:Full timeBUILDING A WORLD CLASS TEAM STARTS WITH YOUAt the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It's been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500 standards, codes &...
-
Certifier II
2 weeks ago
Bengaluru, Karnataka, India CSA Group Full time ₹ 9,00,000 - ₹ 12,00,000 per yearEmployment Status:RegularTime Type:Full timeBUILDING A WORLD CLASS TEAM STARTS WITH YOUAt the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It's been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500 standards, codes &...
-
Safety Science Coordinator II
2 weeks ago
Bengaluru, Karnataka, India Fortrea Full time ₹ 9,00,000 - ₹ 12,00,000 per yearJob Overview:Assist with the overall Clinical Safety and/or PSS operations associated with products including the adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expendable adverse events to the required standard and submit them to the client and...
-
Safety Science Coordinator II
5 days ago
Bengaluru, Karnataka, India Fortrea Full time ₹ 4,00,000 - ₹ 8,00,000 per yearJob Overview:Assist with the overall Clinical Safety and/or PSS operations associated with products including the adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expendable adverse events to the required standard and submit them to the client and...
