Associate Director Safety Medical Writing
Associate Director Safety Medical Writing
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Job Description
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
Experienced leader to oversee Medical Device Vigilance and Safety services. This role will be responsible for developing and implementing pre and postmarket surveillance (PMS) strategies ensuring compliance with global regulations and managing safety reporting for our medical device portfolio.
Key Responsibilities:
- Develop and implement medical device vigilance strategies aligned with regulatory requirements
- Ensure compliance with global regulations for medical devices including EU MDR FDA and other market requirements
- Overall management of individual case safety reports (ICSRs) and medical device reports (MDRs) / postmarket surveillance activities
- Direct preparation and review of Periodic safety update reports (PSURs) Clinical evaluation reports (CERs) and other regulatory submissions
- Lead discussions with notified bodies and regulatory authorities on safety data for medical devices / drugdevice combination products as applicable
- Manage a unit of medical device safety professionals including implementing training programs
- Collaborate with crossfunctional teams (Clinical Affairs Quality Assurance Regulatory Affairs) on safety strategies and product development
- Oversee risk management plans and benefitrisk assessments for medical devices
- Leverage data analytics for signal detection and trend analysis in medical device safety
- Contribute to longterm strategic planning for device safety activities
Qualifications:
- Advanced degree in Life Sciences Pharmacy Medicine Medical devices or related field
- Minimum 8 years of experience in PMS / medical device vigilance with at least 5 years in a leadership role
- Extensive knowledge of global medical device regulations particularly EU MDR and FDA requirements
- Strong understanding of medical device vigilance processes and best practices
Required Experience:
Director
Employment Type
Full-Time
