Drug Safety Associate (USA)

Experience: 0 to 5 yrs.  | Salary: U.S Dollars 45,000 - 60,000 P.A  |  Opening(s): 10

Key Accountabilities:

-Introduction to clinical research
-Fundamentals of Pharmacovigilance
-Regulations in Pharmacovigilance: FDA, ICH
-Adverse events and its types
-Different sources of Adverse events reporting
-Different types of AE reporting forms
-Expedited reporting and its timelines
-Different departments working on Pharmacovigilance
-Roles and responsibilities of case receipt unit 
-Four factors for the reportable case 
-Seriousness criteria of adverse event 
-Expectedness or Listedness of adverse event
-Causality assessment of the adverse event 
-Introduction to safety databases and different types 
-Triage of cases 
-Forms used: AERS, Medwatch, CIOMS 
-Document management/privacy/follow-up information obtaining and -documenting for ICSRs
-Database overview & database usage
-Identifying a valid case and case processing
-MedDRA coding and WHODD
-Exercises for MedDRA coding practice 
-Pharmacovigilance event ranking/using the always serious list/rush cases card/upgrading serious to non-serious, and non-serious to serious case --.Unifying a diagnosis/lack of effect/event identification and upgrading adverse events/co-licensing partner process
- Multiple suspect products/drug interaction/overdose 
-Medical review process 
-Line listing/PSURs/SUSAR processing
-Case quality check, Medical review and its submission. 
-Narrative Writing
-Exercises and practicing with writing narratives 
-Overall workflow of a drug safety associate

Essential Function:

The Drug Safety Officer is responsible for collecting, monitoring, processing, and distributing of adverse event reports and information queries for investigational and marketed products. He or she is also responsible for safety and medical information for the assigned products, including safety components of protocols and studies for assigned drugs.

Skills:

Ability to communicate with professional medical personnel. Understanding of the drug development process. Ability to complete tasks in an accurate and timely manner.

-Act as the internal safety resource in connection with safety issues
-Support other departments in safety issues, i.e. participate in the preparation of local informed consent and 'safety-sections' of development protocols
-Active involvement in internal and external developments through close internal interactions and through participation in external safety meetings and assessment of external national safety information
-Develop and execute training programs for personnel
-Obtain and verify new information concerning pharmacovigilance.

Physical Requirements: Ability to travel an average of 60-65% all across United States and Canada.

Contact Details

Recruiter Name:

Ms.Meenu

Contact Company:

THE VERITAS CAREER SOLUTIONS PVT LTD

Email Address:

Telephone:

91-172-5044885