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Clinical Safety Manager

vor 3 Monaten

Lausanne, Schweiz Debiopharm Vollzeit

Description

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.

For our Clinical Safety and Pharmacovigilance organization based at our Headquarters in Lausanne, we are looking for a

Clinical Safety Manager

**Mission**:
Reporting to the Head of Clinical Safety, the mission of the Clinical Safety Manager is to lead a team of Clinical Safety Officers (CSOs) ensuring high-quality performance of clinical safety activities in clinical trials for a portfolio of Debiopharm compounds under clinical development.

**Your responsibilities will be but not limited to**:
TEAM LEADERSHIP

Manage, organize, lead, motivate, develop, and retain a high performing team of CSOs to ensure operational excellence of clinical safety activities in clinical trials in line with SOPs and regulations.
Set goals, actively coach, and provide performance feedback to team members, ensuring that their targets are aligned with business priorities. Hold teams accountable for the timely achievement of their objectives.
Ensure that the appropriate staffing levels, capabilities, and competencies are in place to secure the sustainable achievement of short and long-term program & study milestones and department goals.
Improve clinical safety processes, identify issues, proposes solutions/action plans and escalate appropriately to the Head of CS.
Liaise with the Head of CS to identify projects needs and requirements for clinical safety activities (including launch of new clinical trials, budget review, headcount review) and ensure appropriate workload distribution between CSOs to secure operational activities.
Ensure that clinical safety activities (case processing, safety reporting, SAE reconciliation and safety surveillance activities) are conducted according to trial-specific Safety Management Plans (SMPs).
Manage clinical safety vendors and generate compliance metrics / Key Performance Indicators (KPI).
Participate in audits / inspections.
Manage CAPA for clinical safety related activities.
Contribute to instil a culture aligned with Debiopharm Values, Signature and Winning Behaviours

CLINICAL SAFETY OPERATIONS

**Requirements**:
Scientific Degree (Biology, Pharmacy )
More than5 years of experience in Clinical Safety and Pharmacovigilance with good knowledge of GCP and GVP as well as pharmacovigilance and global clinical safety methodology, EU and US regulations, guidelines, and standards
At least 1 year of line management experience
Strong communication, listening and motivating skills.
Team leader, flexible and willing to support and work with employees at all levels in the organization and across all functions.
Positive can-do attitude, ability to face challenges and solve problems.
Knowledge and experience of safety monitoring and signal detection methodology
Experience in Oncology
Solid experience in drug development and clinical research at different phases (mainly I-II)
Proficient with use of coding dictionaries and safety database
Strong analytical and organizational skills, as well as familiarity with medical terminology
Excellent time management skills and capability to prioritize.
Excellent written and verbal communication skills and ability to interact with a wide range of people.
Ability to work independently and as a team-player,
Fluent in English

**Benefits**:
**Debiopharm offers employees**:
International, highly dynamic environment with a long-term vision.
Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities.

Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create an