Safety Scientist (partly remote)

Posted 19 Jeudi mai
SalaireVerhandelbar
LieuBâle
Type d'offre Temporaire
secteurScienceLife Sciences
RéféreneBBBH534878_1652965354

Job description

The world market leader in pharmaceutical industry is looking for highly experienced Pharmacovigilance/ Safety experts, with hands-on experience in clinical trial/ mature products safety and risk management, protocols e.g., for its headquarter in Basel, Switzerland. The Portfolio Safety Scientists (PCS-Sci) provide Safety Science and Pharmacovigilance support to molecules across the portfolio. As a group, they are responsible for all aspects of Safety Science/ Pharmacovigilance, with accountability being held by PCS leadership or SSLs (Safety Strategy Program Leaders) depending on the deliverable/activity

Safety Scientist (partly remote)

To support internal team movements, we are looking for 3 Clinical Safety Scientist to join the group and hit the ground running. We need senior profiles, able to be independent, without extensive training. We are looking for someone with a minimum of 5 to 7 years of relevant experience in Safety (DSR, CSR, IB, DSUR, etc.) and with a Life Science education background.Portfolio Safety Scientists (Level 4) are recognized to have strong expertise in drug safety and will be expected to work with minimal oversight and apply strong self-leadership. They will bring safety expertise to interactions with internal stakeholders, Regulatory Authorities and Data Monitoring Committees and must have the ability to interact effectively in a multifunctional and multicultural team setting. The job holder will be expected to identify areas of development and complete the required training. The SSL is the lead safety accountable for the molecule safety strategy

Your tasks

  • Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action)
  • Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance. Contribute to the review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
  • Provide expert contribution to the development of the product safety strategy
  • Take independent responsibility for risk management activities including preparation and maintenance of CCDS, labeling document maintenance (including IB), risk communications, RMP, REMS
  • Review of clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication
  • Take responsibility for safety science contributions to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations,
    Renewals, etc.)
  • Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB
  • Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
  • In partnership with the SSL, support presentation of important safety issues to the Drug Safety Committee (DSC), Development Review Committee (DRC) and other internal and external review and governance committees as needed
  • May be expected to support non-molecule projects, due diligence evaluations and other projects as needed
  • Perform specialized roles within PCS. These may include, but are not limited to: Functional business process owner, subject matter expert, safety committee member
  • Responsible for coordination and collaboration with vendors servicing Safety Science

Additional responsibilities, under the delegated accountability of the SSL:

  • Contribute and/or lead the development of the safety components of the Target Product Profile (TPP), key claims and other lifecycle strategic planning documents (e.g., IDCP, CDP)
  • Accountable for the safety components of study reports, aggregate reports and high level regulatory documents
  • Acquire and contribute knowledge of relevant drug class and/or competitor safety issues. Lead development of the safety surveillance strategy, identify potential clinical safety issues and recommend appropriate safety monitoring measures
  • Lead the development of scientific publications (abstracts, posters, papers) for scientific meetings/journals and approve the submissions from a safety perspective
  • Enable/facilitate the transition of appropriate drug candidates from EMS to LMMS

Behaviours and responsibilities:

  • Understands how safety activities contribute to company development and commercialisation goals and takes measures to maximize safety value to the organization
  • Establish and maintain collaborative working relationships with all key stakeholders, and internal and external customers and ensure the same across relevant teams
  • Trains and mentors more junior PCS scientists
  • Takes on team leadership responsibility in order to manage and complete medium and high priority projects
  • Seen by peers and cross-functional colleagues as an expert in many safety science activities
  • Contributes to embedding the agreed organizational models, and the necessary mindsets
  • Brings critical, systematic thinking to shape current issues and opportunities into meaningful, deliverable actions
  • Willing to challenge embedded behaviors/mindsets, in order to bring new and agile approaches to ways of working, and/or to improve quality and efficiency

Your qualifications

  • Education in Life Sciences
  • Minimum 5 to 7+ years of relevant hands-on experience in Safety/Pharmacovigilance
  • 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.
  • Ability to demonstrate a broad understanding of the scientific aspects of safety, PV and Cllinical/ Patient Risk Management (e.g. via demonstrable knowledge of the application of GVP, GCP & CTR requirements) is essential
  • Demonstrated ability to lead and influence, with and without authority, in a global matrix environment
  • Excellent written and verbal communication skills in English

Your application
Please apply online. For further information about the position, please contact your Kelly consultant, Mr. Andreas Danner, Dr. med. Dipl.-Biol. (+41 44 225 41 07/ +41 76 310 760 9)

About Kelly We connect people to jobs in ways that enrich lives. Kelly Services® is a leading global provider of human resources solutions, operating in over 40 countries. Together with its subsidiaries, Kelly offers a wide range of outsourcing and consulting services; temporary, permanent and management positions as well as flexible forms of employment at all hierarchy levels. Kelly Services (Schweiz) AG has been present in Switzerland since 1979 and counts more than 200 employees in over 40 Talent Offices and Centers.