Senior Safety Scientist (m/f/d)

Senior Safety Scientist (m/f/d) – GxP / ICSR Case Management / Risk Management / Clinical Trial / English

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Senior Safety Scientist (m/f/d).

Background:
As a group, Portfolio Safety Scientists (PCS-Sci) are responsible for all aspects of safety science/pharmacovigilance, with accountability being held by PCS leadership and experts or SSLs (Safety Strategy Program Leaders) depending on the deliverable/activity.

The Portfolio Safety Scientists (PCS-Sci) supports early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting this may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management. A Senior Safety Scientist will be supported by supervision from one or more experienced colleagues but is expected to be able to work unsupervised on less complex deliverables.

The perfect candidate:
We are looking for a safety scientist with at least 5 years of experience in drug safety, clinical development or medical affairs. The perfect candidate holds a Masters degree in life sciences along with relevant experience within the pharmaceutical industry. Hands-on working experience with Risk Management Plan, Protocols, DSR as well as data analysis / statistical methods are a must.

Tasks & Responsibilities:

• Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas
  ● Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER)
  ● Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance. Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
  ● Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS
  ● Contributing to study management from a safety perspective through SMT/PET and document review and maintenance across the development continuum (early phase to post marketing studies), including PASS
  ● Acts independently to manage safety responsibilities on study teams and in activities supporting safety science
  ● Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with SSL and PCS Team Lead
  ● Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
  ● Responsible for coordination and collaboration with vendors servicing Safety Science
  ● Take on the responsibility for appropriate specialized roles with PCS. These may include, but are not limited to: functional business process owner, subject matter expert.
  ● Establish and maintain collaborative working relationships with all key stakeholders, and internal and external customers and ensure the same across relevant teams
  ● Consistently comply with all governing laws, regulations, Roche standard operating procedures
  (SOPs) and other guidelines

Must Haves:

• Qualified healthcare professional or Life Sciences with a relevant postgraduate qualification – minimum Masters (e.g. PHD/MSc in a Life sciences discipline; Medical qualification; PharmD )
  ● 5 or more years of drug safety, clinical development or medical affairs experience in the pharmaceutical or related industry (no safety operational activities experience accepted)
  ●Hands-on experience with clinical trial and mature products safety
  ●Hands-on working experience with Risk Management Plan, Protocols, DSR, DSUR, CSR, IB, Adverse Events, etc.
  ● Perform data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
  ● Understanding of GxP and regulated processes and end to end clinical trial lifecycle
  ● Strong orientation towards process improvement and cross-functional teamwork
  ● Excellent written and verbal communication skills in English.

Reference Nr.: 922720TP
Role: Senior Safety Scientist (m/f/d)
Industrie: Pharma
Workplace: Basel
Pensum: 100%
Start: 01.09.2023
Duration: 12 months
Deadline: 29.06.23

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.