What are the responsibilities and job description for the Senior Manager - Compliance and Drug Safety and Pharmacovigilance Operations position at Apex Systems?
Job Details
Job#: 2062348
Job Description:
Senior Manager - Compliance and Drug Safety and Pharmacovigilance Operations
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 Directors 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:
Bachelors in nursing, pharmacy, or life sciences required; Masters 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 Google Cloud Platform/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.
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable 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 our Employee Services Department at or .
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
Job Description:
Senior Manager - Compliance and Drug Safety and Pharmacovigilance Operations
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 Directors 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:
Bachelors in nursing, pharmacy, or life sciences required; Masters 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 Google Cloud Platform/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.
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable 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 our Employee Services Department at or .
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
