
Principal, Pharmacovigilance / Device Vigilance
Are you a highly experienced and driven leader in the field of pharmacovigilance and device vigilance? Do you have a strong background in the biotech or pharmaceutical industry? Natera is seeking a dynamic and passionate individual to join our team as Principal of Pharmacovigilance/Device Vigilance. In this role, you will play a critical role in overseeing the safety and risk management of our products, ensuring compliance with global regulations and guidelines. If you are a strategic thinker, possess strong leadership skills, and have a keen eye for detail, we want to hear from you. Join us in our mission to improve patient outcomes and make a meaningful impact on the healthcare industry.
- Develop and implement pharmacovigilance and device vigilance strategies for Natera's products in compliance with global regulations and guidelines.
- Oversee the safety and risk management of Natera's products throughout their lifecycle, including signal detection, risk assessment, and risk mitigation.
- Monitor and analyze safety data from clinical trials, post-marketing surveillance, and other sources to identify potential safety concerns.
- Lead and manage the pharmacovigilance and device vigilance team, providing guidance, mentorship, and support to ensure their professional growth and development.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, medical affairs, and quality assurance, to ensure alignment on safety and risk management strategies.
- Serve as the primary point of contact for regulatory agencies and other external stakeholders on pharmacovigilance and device vigilance matters.
- Conduct regular safety review meetings and provide updates to senior management on the status of pharmacovigilance and device vigilance activities.
- Develop and maintain relationships with key opinion leaders and external experts in the field of pharmacovigilance and device vigilance.
- Stay updated on emerging trends, regulations, and industry best practices related to pharmacovigilance and device vigilance.
- Identify opportunities for process improvement and implement changes to enhance the efficiency and effectiveness of pharmacovigilance and device vigilance activities.
- Represent Natera at relevant conferences and meetings to build awareness and credibility in the field of pharmacovigilance and device vigilance.
- Ensure compliance with company policies, procedures, and ethical standards.
- Promote a culture of safety and patient-centricity within the organization.
- Provide strategic inputs to support product development and commercialization decisions.
- Conduct audits and inspections to ensure compliance with pharmacovigilance and device vigilance requirements.
Advanced Degree In A Relevant Field: A Principal In Pharmacovigilance Or Device Vigilance At Natera Should Have A Minimum Of A Master's Degree In A Relevant Field Such As Pharmacology, Life Sciences, Or Public Health. This Advanced Degree Will Provide The Necessary Knowledge And Skills To Effectively Lead And Manage The Pharmacovigilance Team.
Extensive Experience In Pharmacovigilance: The Ideal Candidate Should Have At Least 8-10 Years Of Experience In Pharmacovigilance In A Leadership Role. This Experience Should Include A Deep Understanding Of Pharmacovigilance Regulations And Guidelines, Adverse Event Reporting, Signal Detection, Risk Management, And Safety Surveillance.
Knowledge Of Device Vigilance: In Addition To Pharmacovigilance, The Principal Should Also Have A Strong Understanding Of Device Vigilance. This Includes Experience With Medical Device Regulations, Post-Market Surveillance, And Adverse Event Reporting For Medical Devices.
Leadership And Management Skills: As A Principal, This Individual Will Be Responsible For Leading And Managing A Team Of Pharmacovigilance And Device Vigilance Professionals. Therefore, Strong Leadership, Communication, And Team-Building Skills Are Essential For This Role.
Regulatory Compliance Knowledge: Natera Is A Highly Regulated Company, And The Principal In Pharmacovigilance Or Device Vigilance Should Have A Thorough Understanding Of Regulatory Requirements And Guidelines, Including Fda Regulations, Ich Guidelines, And Other Relevant Global Regulations. This Knowledge Will Ensure That Natera Remains Compliant With All Pharmacovigilance And Device Vigilance Regulations.
Risk Management
Quality Assurance
Process Improvement
Data Analysis
Communication
Incident investigation
Team Leadership
Regulatory Knowledge
Compliance Oversight
Safety Reporting
Signal Detection
Adverse Events
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
flexibility
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Principal, Pharmacovigilance / Device Vigilance is $140,000 - $180,000 per year. However, this can vary depending on factors such as location, experience, and employer.
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Natera is a genetic testing company that operates a CLIA-certified laboratory in San Carlos, California.

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