Beschreibung
Harvey Nash is looking for a Pharmacovigilance Leader for a 3 + month project in Switzerland.
The role is for performing pharmacovigilance activities for assigned projects or products including identification and analysis of safety signals based on a comprehensive evaluation of post-marketing data and Serious Adverse Events (SAEs) from clinical trials..
You are responsible for
Monitoring the clinical safety of projects/products including medical assessment and related follow up activities for single cases, medical evaluation of quality defects, reviewing of line listings of single cases, and preparation of investigator notifications Contributing to the iodic safety update report (PSUR) including analytical input to PSUR for known and potential risks defined in the RMP Assisting in the development, maintenance and implementation of the RMP including the coordination with other line functions for associated activities such as updates, management of large datasets for analysis purposes and the ongoing tracking of commitments and effectiveness measures Contributing or leading creation of other safety deliverables including but not limited to clinical overviews, ad hoc health authority queries, drug safety product profile (DSPP), drug safety update report (DSUR) Providing safety input to DRA and clinical documents (eg core data sheet, clinical study protocols and investigator brochure) Performing sig triage, signal detection, and evaluation based on single cases, aggregate data and signal detection tools Preparing safety data for health authority review boards; Providing input to responses for legal queries and CPO requests involving safety issues Providing pharmacovigilance input to initial development of the core data sheet (CDS) and associated documents such as the clinical overview Providing guidance as appropriate to Clinical Safety Operations for the coding and causality/expectedness assessment of adverse event reports Collaborating productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments Participating in review of clinical study protocols/reports/other clinical documents and data from ongoing clinical trials as needed Mentor newly recruited colleagues supporting their integration into the PVE role Requirements
3 years clinical experience postdoctoral (after graduation from pharmacy/nursing/medical school) At least 3 years in drug development in a major pharmaceutical company including 2 years in drug safety at an operational or medical position Bachelor of Science in Pharmacy/Bachelor of Science in Nursing/PharmD/PhD in relevant field or Medical Degree (MBBS or MD), required Medical degree with specialization preferred Proven ability to analyze, interpret, discuss, and represent safety information both in writing and orally Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information Experience with (safety or others) issue management Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications Fluent in spoken and written English. Understanding in another major language (eg French, German, Spanish) preferred. Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred)
For further details feel free to call me. I am looking forward to receiving your application.
