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Senior Manager, Drug Safety & PV, Quality Standards & Training

Net2Source

Princeton, NJ

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JOB DETAILS
SALARY
$70–$76.19 Per Hour
SKILLS
Agile Programming Methodologies, Analysis Skills, Biology, Business Continuity Planning (BCP), Calendar Management, Clinical Research, Clinical Trial, Communication Skills, Cross-Functional, Customer Relations, Customer Support/Service, Data Analysis, Detail Oriented, Develop Methodologies, Establish Priorities, Event Management, FDA Requirements, ICH Regulations, Industry/Trade Analysis, International Health, Interpersonal Skills, Interpret Regulations, Leadership, Maintain Compliance, Marketing, Medical Affairs, Organizational Skills, Performance Analysis, Performance Metrics, Pharmacovigilance, Physical Demands, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Process Improvement, Project Evaluation, Quality Management, Quality Metrics, Regulations, Regulatory Requirements, Risk Management, Safety Standards, Schedule Development, Standard Operating Procedures (SOP), Strategic Planning, Surveillance, Time Management, Training Program, Willing to Travel
LOCATION
Princeton, NJ
POSTED
2 days ago
Join a Global Leader in Workforce Solutions – Net2Source Inc.
Who We Are
Net2Source Inc. isn't just another staffing company, we're a powerhouse of innovation, connecting top talent with the right opportunities. Recognized for 300% growth in the past three years, we operate in 34 countries with a global team of 5,500+. Our mission? To bridge the talent gap with precision—Right Talent. Right Time. Right Place. Right Price.

Job Description:
Job Title: Senior Manager, Drug Safety & PV, Quality Standards & Training
Location: Princeton, NJ 08540
Duration: 12+ Months (Extendable)
 
Duties:            
In support of client and fulfillment of global legislation and regulations, the Senior Manager will be responsible for the global oversight for quality and compliance of the Pharmacovigilance (PV) and risk management activities. This is accomplished through setting and articulating the vision for the PV system including but not limited to development and execution of global processes, standards, training programs and compliance monitoring.
Primary Responsibilities
• Supports all compliant PV system related activities, by ensuring appropriate processes are in place for the collection, collation, evaluation and submission of individual case safety reports and aggregate reports in accordance with international regulatory requirements.
• Assists with implementation of drug safety standards across other areas that input to the PV system such as clinical research, medical affairs, commercial, etc.
• Contributes to the preparation and presentation of Key Performance Indicator (KPI) reports.
• Supports Drug Safety & PV (DSP) Training administration and management. Liaise with client stakeholders to ensure all vendors are also properly trained and training is documented.
• Maintains all required SOP training matrices for all DSP roles.
• Supports PV inspections and audits; collaborates cross-functionally in preparation of responses to findings.
• Leads monitoring and management of DSP quality events/deviations investigations.
• Evaluate adequacy and completeness of CAPAs and Effectiveness Checks (ECs) originated from audits, and/or quality events/deviations.
• Supports Quality Management Reviews for all DSP deliverables.
• Supports DSP procedural development and maintenance; collaborating with Subject Matter Experts (SMEs); liaises with other departments on cross-functional procedures that involve DSP.
• Supports Regulatory Intelligence for DSP
• Contributes to documents describing the PV system as required by regulations (e.g., EU PV Masterfile).
• Assist in preparation and execution of DSP Business Continuity Plan in collaboration with other stakeholders (e.g., IT, Regulatory).
• Other duties as assigned.
 
Skills:
  • Experience in quality systems, establishing and tracking performance metrics, compliance monitoring, development and maintenance of SOPs and training programs, and PV systems/databases.
  • Experience with Veeva and ARGUS is preferred.
  • Solid knowledge of and experience with FDA and EU regulations and ICH guidelines related to pharmacovigilance including safety monitoring and reporting in clinical trials, post-marketing surveillance, case processing, and reporting to Health Authorities worldwide.
  • Ability to assess evolving regulatory landscape, weigh possible courses of action, provide advice and make sound decisions.
  • Ability to drive standards and change across functional areas and sites.
  • Strong attention to detail in establishing priorities, scheduling and meeting deadlines.
  • Ability to work independently, take initiative and complete tasks to deadlines.
  • Excellent interpersonal, communication, analytical and organizational skills.
  • Demonstrated ability to motivate, lead and train others.
 
Scope
  • Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives. Establishes strategic plans for designated function(s).
  • Develops methods, techniques, and evaluation criteria for projects, programs, and people. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives.
  • Erroneous decisions will have a serious impact on the overall success of functional area and may impact the long term success of the Company.
 
Physical Requirements
  • While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations.
  • Employee must occasionally lift and/or move up to 15 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business issues.
 
Education:    
  • Bachelor’s degree in Life Science or related field.
  • Targeting 5 years of progressively responsible experience within the pharmaceutical or biotech industry, including 3 years in Pharmacovigilance with prior oversight of PV compliance, quality and training.
  • Must have experience with industry interpretation of regulatory expectations and with pharmacovigilance inspections by major global Health Authorities.
  • An equivalent combination of relevant education and experience may be considered.

Why Work With Us?
We believe in more than just jobs—we build careers. At Net2Source, we champion leadership at all levels, celebrate diverse perspectives, and empower you to make an impact. Think work-life balance, professional growth, and a collaborative culture where your ideas matter.
Our Commitment to Inclusion & Equity
Net2Source is an equal opportunity employer, dedicated to fostering a workplace where diverse talents and perspectives are valued. We make all employment decisions based on merit, ensuring a culture of respect, fairness, and opportunity for all, regardless of age, gender, ethnicity, disability, or other protected characteristics.
Awards & Recognition
• America's Most Honored Businesses (Top 10%)
• Fastest-Growing Staffing Firm by Staffing Industry Analysts
• INC 5000 List for Eight Consecutive Years
• Top 100 by Dallas Business Journal
• Spirit of Alliance Award by Agile1
Ready to Level Up Your Career?
Click Apply Now and let's make it happen.

About the Company

N

Net2Source

Net2Source Inc. is a Global Workforce Management Solutions Company, headquartered in New Brunswick, NJ with its local offices in Texas, California, Florida, Illinois, Colorado and Michigan and its global operations in Canada, UK, Europe, UAE, Malaysia, Australia, China, Singapore and India. Net2Source offers a wide gamut of consulting solutions customized to specific client needs including but not limited to Application Development, Workforce Management and Project Consulting. Whether it’s a Fortune client, whether it’s a System Implementer or whether it is a Start -up, our recipe to success – Exceed expectations! Under promise, over deliver.
COMPANY SIZE
50 to 99 employees
INDUSTRY
Other/Not Classified
WEBSITE
http://www.net2source.com

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