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Precision For Medicine
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Safety Specialist I

Safety Specialist I

Precision For Medicine

2 - 7 years

4 - 9 Lacs

bengaluru

Posted:Just now| Platform:

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Skills Required

cro nursing data management pharma pharmacy reconciliation clinical trials pharmacovigilance oracle drug safety

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

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