Safety & PV Specialist- xEVMPD

Job Description

*SPVG Scientific Specialist I Come discover what our 25,000+ employees already know: work here matters everywhere. We re a growing and evolving biopharmaceutical industry leader, which means you ll have endless opportunities to work with experts around the world and build the career you ve dreamed of. As a part of the Syneos Health team, you ll help us deliver results for a rewarding reason we improve patients lives around the world. Because to us, a patient isn t just a number, they re our family, friends, and neighbors.Why Syneos Health #SyneosHealthLife means we re committed to our Total Self culture where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person s unique contributions make a difference. We believe our success is a direct result of the people who are driving it you We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives we re able to create a place where everyone feels like they belong.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, *What we re looking for
• Qualification: M. Pharmacy, life science equivalent degree
• Good written and verbal communication skills (command of English equivalent to level of B2 of the CEFR)
• Minimum 2 years of experience in handling xEVMPD data
• Population or review of xEVMPD data in product database from SmPC and other source documents (PIL/MA letter) including MedDRA and drug coding
• Experience of working on product database like RIMS, xEVMPD / Article 57 database
• In-depth knowledge of xEVMPD guidelines (e.g. Art57 Chapter 3.2, splitting of full presentation name, substance name best practice etc.)
• Database to be used - Art57 (EVWeb), any other database related to xEVMPD record submissions
• Review of xEVMPD records already submitted by MAH:
• Validation (review or quality control) of the information available in the xEVMPD record against
• the source document (e.g. SmPC, PIL, MA approval letter) attached by the MAH to product records
• Correction of product record data based on validation findings including MedDRA coding of indications
• Coding of product indications using latest version of MedDRA. Analyse and respond to queries related to xEVMPD data

Keyskills :
standard operating proceduresclinical trialscase processingaudio masteringdrug developmentwork instructions