Senior Safety Data Specialist
hace 2 semanas
Job Description:
Our Quantitative Sciences team use big data to analyze the safety and efficacy claims of our potential medical breakthroughs.
We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.
Responsibilities and Primary Activities (may include but are not limited to):
- Performs all core responsibilities of the Senior Safety Data Specialist (SSDS) in addition to processing of the most complex AE reports.
- Independently and consistently meets Key Performance Indicators (KPIs) for quality and compliance.
- Assists GPVCM Management to identify opportunities for business and/or operational process improvement to ensure/improve Quality and Compliance as well as increase efficiency and effectiveness.
- Assists GPVCM Management to prepare and respond to Regulatory Agency inspections as well as internal and external audits.
- Monitors and analyzes key performance indicators to ensure adherence at process level and overall GPVCM team level. Assists with root cause analysis and oversees implementation of action plans when appropriate.
- Serves as a GPVCM expert to effectively interact and communicate with internal and external stakeholders for the resolution of complex issues. Organizes and/or actively participates in the global network within GPVCM or with stakeholders to discuss process issues or inconsistencies, to create solutions, and works with Global Pharmacovigilance as appropriate to improve, standardize and optimize processes.
- Provides process expertise and conducts periodic assessments (if needed) to ensure established processes are being followed consistently and appropriately.
- Coordinates and performs quality and compliance assurance/control related processes and tasks.
- Initiates and coordinates updates of guidance documents to guarantee global deliverables and alignment. Assists managers with the development and implementation of departmental procedures and educational programs.
Education and other Qualifications:
- Bachelor's Degree in Health Care or role related discipline
- Master's degree desired
- Advanced writing/reading and advanced speaking/listening English language skills
- Minimum 2 years' experience in in Pharmacovigilance or role related field
Professional Competencies:
- Working Across Boundaries (Applying).
- Strategic Thinking (Learning)
- Project Management (Applying).
- Productive Communication (Applying).
- Problem Solving (Applying).
Core Functional Competencies:
- Data Analysis, Interpretation & Communication (Applying).
- Competitive Decision Making & Execution (Learning).
- Collaboration & Partnering (Applying).
- Business & Operations Management (Applying).
- Regulatory & Compliance Management (Applying).
- Disease Area Knowledge (Sub Competencies) (Learning).
Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world.
We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
LI-DNI
Search Firm Representatives Please Read Carefully
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
**Valid Driving
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