Safety Scientist - PHARMA

Highly Competitive
  1. Contract
  2. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP)
  3. Switzerland
Basel
Posting date: 13 Mar 2019
QA.AR.22011_1552493592

ProClinical is advertising a vacancy for a Safety Scientist position with a multinational healthcare organisation who provide an innovative range of diagnostic solutions and medicines. This is an exciting opportunity to join this leading company in their office in Switzerland. This is a contract position covering an employee's maternity leave.

The Safety Scientist will support early and late phase development activities as a member of the safety team under the leadership of the Safety Science Leader (SSL), providing essential safety oversight and input into all aspects of study management across the entire development portfolio. In the post-market setting, this role contributes to safety science deliverables required to maintain a license to operate, manage, and communicate the evolving safety profile.

Job Responsibilities:

  • Representing Safety Science with business process owners on processes executed by Safety Science.
  • Coordinating and collaborating with vendors servicing Safety Science In collaboration with the SSL.
  • Responsible for individual and aggregate case reporting activities, including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER).
  • Overseeing signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance, and drug safety reports.
  • Contributing to risk management activities, including preparation and maintenance of CCDS, labelling document maintenance, risk communications, RMP, and REMS.
  • Contributing to study management through SMT/PET and document review across the development continuum (early phase to post marketing studies), including PASS.
  • Interfacing with business process owners on processes executed by Safety Science.
  • Coordinating and assisting in responding to Health Authority requests.
  • Responsible for supporting processes involving safety science such as the expected terms list, MedDRA baskets, ICF process, etc.
  • Supporting product quality issues.
  • Carrying out activities related to quality system management for safety science.

Skills and Requirements:

  • Bachelor's degree in healthcare related field or equivalent experience.
  • Proven work experience in pharma safety, pharmacovigilance or other related pharmaceutical development area preferred.
  • An appreciation of GxP (GVP) and regulated processes and end to end clinical trial lifecycle.
  • Strong orientation towards cross-functional teamwork.
  • Capable of working with remote partners and teams across global sites.
  • An understanding of application of data analysis / statistical methods to evaluate, interpret and present scientific data with clarity.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.
  • Mid-Senior Level.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Andrea Rotmistrovsky at +44 203 854 0675 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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