Associate Safety Director(f/m/d)

Associate Safety Director(f/m/d) - drug development / safety/PV/ Safety Database/ product safety/ signal detection/ risk management (RMP/CCDS)/ complex data analysis/Stakeholder Management/ English

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Associate Safety Director.

Background:
Portfolio Safety Scientists (PCS-Sci) provide safety science and pharmacovigilance support to molecules across the Roche portfolio. As a group, they 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. The Associate Safety Director will be expected to work with minimal supervision and apply strong self-leadership. The job holder will be expected to complete the required training.

The perfect candidate is an Associate Safety Director with at least 4 years of drug development experience, including a minimum of 3 years in drug safety/pharmacovigilance, and is a qualified healthcare or life sciences professional. This individual must possess the expert understanding required to proactively manage all aspects of product safety, including signal detection, risk management (RMP/CCDS), and complex data analysis, while ensuring all documentation and regulatory submissions adhere to GxP standards..

Tasks & Responsibilities:
Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas. 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).

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p>? 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. Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (incl, 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.
? 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.
? Acts independently to manage safety responsibilities on study teams and in activities supporting clinical safety.
? Take on the responsibility for specialised roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert.
May be expected to support non-molecule projects, due diligence evaluations and other projects as needed.
? Perform specialized roles with 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.
Understanding of GxP and regulated processes and end to end clinical trial lifecycle .
? Strong orientation towards process improvement and cross-functional teamwork.
? Effectively work with remote partners on a global team.
? Excellent communication skills, both written a j4id9886124a j4it1041a j4iy25a