Associate Safety Director
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Job Location:
Basel - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
We deliver knowledge on the safety profiles of our medicines define how to manage risks to patients and coordinate the pharmacovigilance system activities for the company providing a safe journey for each individual patient everywhere.
The Opportunity:
Contribute to shaping the future of healthcare by providing essential safety science and pharmacovigilance support across the entire Roche portfolio influencing both early and late-phase development activities.
Serve as a key member of the safety team offering crucial safety oversight and input into all aspects of study management from development through post-market.
Lead critical post-market safety activities including signal evaluation benefit-risk assessment and comprehensive safety risk management.
Take ownership of individual and aggregate case reporting encompassing ICSR case management and critical aggregate reporting activities like DSUR and PBRER.
Drive signal detection and management maintaining STAR and ISMP and contributing to the strategic review of safety assessments and drug safety reports.
Influence product safety strategy and provide vital drug safety input into the overarching Clinical Development strategy.
Contribute significantly to risk management by preparing and maintaining CCDS labeling documents (including the IB) risk communications RMP and REMS.
Act independently with minimal supervision demonstrating strong self-leadership and proactively identifying and pursuing areas for personal and professional development.
Who you are:
A qualified healthcare professional or Life Sciences graduate with a preferred postgraduate qualification (e.g. PHD/MSc in Life sciences PharmD).
Possess 4 or more years of drug development experience in the pharmaceutical or related industry with at least 2 years specifically in drug safety or a closely related field.
Demonstrate a strong understanding of GxP regulated processes and the end-to-end clinical trial lifecycle.
Exhibit excellent communication skills both written and verbal capable of effectively collaborating with remote partners on a global team.
Adept at applying complex data analysis and statistical methods to evaluate interpret and present scientific data with clarity.
Possess strong presentation skills effective at summarizing and presenting key considerations and decision points to diverse audiences.
Proven ability to act independently and with minimal supervision managing safety responsibilities on study teams and supporting safety science activities.
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Director
Key Skills
- Program assessment
- FDA Regulations
- Manufacturing & Controls
- Program Evaluation
- budget forecast
- Research Experience
- Operations Management
- Research & Development
- Strategic Planning
- Contract Management
- Leadership Experience
- negotiation
About Company
Petrochem is a market leader in chemical distribution and connecting chemical manufacturers and chemical users throughout the world. Petrochem provides business-to-business distribution solutions for industrial and specialty chemicals. With over10,000products and a highly diverse supp ... View more
