Syneos Health is Hiring Safety & PV Specialist – Non Case Processing Activities

Job Responsibilities

• Assists with safety and pharmacovigilance activities including (but not limited to) literature screening and review, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding, case processing or review of individual case safety reports, authoring or review of aggregate reports and ongoing safety evaluation activities. The processing of information may include filtering, cleaning, migrating, analysing, reporting, filing or publication of data and information.
• Maintains safety tracking for assigned activities
• Fosters constructive and professional working relationships with all project team members, internal and external
• Participates in audits as required/appropriate
• Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities
• Files documents according to project specific requirements (electronically or in hard copy as applicable)
• Provides support with miscellaneous project tasks related to safety and pharmacovigilance activities
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Program Specific FIle or Pharmacovigilance System Master File for post-marketing programs as appropriate
• Maintains an understanding and compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, the drug development process and GVP

Qualifications

Experience: Should have a bachelor degree in life science industry with 2 years of experience in relevant fields.

Responsibilities

• Validating organization name and location of the industries, hospitals and universities related to medicines.
• Creating organization/location by verifying its presence in country specific business register and various other sources like DUNS, Infoclipper and Google etc.,
• Modify/update the data available in OMS database based on information received from different internal systems.
• Make sure address/location is valid based on country specific postal services.
• Coordinate with the customers in handling industry/hospital/university information’s as per their requests.
• Identify duplicate records in the system and merge them accordingly.

Apply HERE