Location: Cambridge, MA (Hybrid)
Science: Small Molecule
Job Overview: This role will ensure PV compliance and operational excellence, partner across teams to uphold safety and regulatory standards, and support the PV Quality system under the Senior Director's guidance.
Primary Job Responsibilities:
· Manages PV Quality System and ensures compliance with inspection standards.
· Provides expertise in safety operations and leads PV metrics development.
· Collaborates on document creation and safety protocols with stakeholders.
· Oversees training, vendor relations, and readiness for inspections and compliance.
Primary Job Requirements:
· Bachelor's in nursing, pharmacy, or life sciences required; Master's or Doctorate preferred.
· Over 5 years in Drug Safety/Pharmacovigilance with a focus on PV Compliance.
· 3-5 years' experience in CRO and vendor management.
· Familiar with GCP/GVP regulations and experienced in regulatory inspections.
· Strong understanding of regulatory standards, with excellent analytical and communication skills.
· Skilled in promoting teamwork and navigating challenges.
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
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