Syneos Health Hiring Safety & PV Specialist I – ICSR (Pharmacovigilance)

Syneos Health Hiring Safety & PV Specialist I – ICSR (Pharmacovigilance)

24 February, 2022

About the job

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

Qualification: M. Pharmacy, life science equivalent degree

  • Should have very good written and verbal communication skills
  • Should have Minimum 2 years of prior experience in Pharmacovigilance and ICSR case processing (or data entry of ICSRs), MedDRA coding, drug coding, narrative writing
  • Good understanding principles laid down in the Guideline on good pharmacovigilance practices (GVP) Module VI, Directive 2001/83/EC, Regulation (EC) No 726/2004
  • Good understanding of requirements applicable to competent authorities in Member States and/or to marketing authorisation holders in the EU
  • Assessment of source data; identification of valid/invalid ICSRs; serious/non-serious ICSRs
  • Data entry of ICSRs/Cases in the agreed database (including suspect and concomitant drug coding, MedDRA coding, reaction/event details, lab data, medical history, patient details, reporter details and other related fields) from the source document
  • Submission of ICSRs/cases within defined timelines
  • Raising follow-up to obtain clarification or missing information

Primary Location

Asia Pacific – IND-Hyderabad-DLF-Cybercity

Other Locations

Asia Pacific – IND-Kinapse-Gurugram, Asia Pacific – IND-Kinapse-Bengalaru

Apply through below link

Safety & PV Specialist I – ICSR | Syneos Health | LinkedIn


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