Manager Jobs

About The Position

Requirements

• Bachelor’s Degree in nursing, pharmacy, life sciences, or a related healthcare/scientific discipline, and 10+ years of experience in pharmacovigilance, drug safety, or patient safety within the biotechnology, or pharmaceutical industry; OR Master’s Degree in a scientific, healthcare, or education-related discipline (e.g. public health, clinical education, instructional design), and 8+ years of experience in pharmacovigilance, drug safety, or patient safety within the biotechnology or pharmaceutical industry; OR PharmD, or equivalent healthcare professional qualification, and 5+ years of experience in pharmacovigilance, drug safety, or patient safety within the biotechnology or pharmaceutical industry
• 5+ years of experience applying global pharmacovigilance regulations and processes (e.g., ICSRs, aggregate reporting, signal detection, PVAs, quality systems)
• 3+ years of experience supporting quality systems and quality records (e.g., deviations, CAPAs, RCA)
• 3+ years of experience supporting audits and regulatory inspections, including inspection readiness and CAPA management
• Demonstrated passion for training, learning innovation, and continuous capability development within a regulated environment, including application of adult learning principles
• Ability to translate complex clinical, regulatory, and pharmacovigilance concepts into clear, practical, and effective training solutions for diverse audiences using learner-centered and adult learning approaches
• Strong pharmacovigilance knowledge, including global regulations, processes (e.g., PV Operations, Safety Risk Management, Affiliate, Alliance, and Contracts, PV Systems), and quality systems, with the ability to apply this knowledge to training and compliance activities
• Strong communication and collaboration skills, with the ability to engage stakeholders and drive alignment across functions to support training and compliance objectives
• Ability to adapt to changing business needs and priorities within a dynamic, regulated environment
• Proven ability to drive results, including supporting CAPAs, root cause analysis, and continuous improvement initiatives, including identification of training-related gaps and learning interventions
• Apply working knowledge of pharmacovigilance processes and requirements to complex situations arising from inspections/audits
• Strong analytical thinking, including the ability to interpret data and translate insights into actionable training and process improvements, including evaluation of training effectiveness and knowledge retention
• Working knowledge of QMS, including training and GPS processes and procedures (e.g., SOPs, PVAs)
• Understanding of audit and inspection processes, including planning and inspection readiness activities
• Ability to operate effectively in a fast-paced, evolving environment and provide cross-functional support within a lean QTC team
• Strategic thinking; ability to analyze opportunities and issues from a broad, long-term perspective, including advancement of training innovation and effectiveness strategies
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook)

Nice To Haves

• Registered Nurse (RN)
• Master’s Degree in a scientific, healthcare, or education-related discipline (e.g., public health, clinical education, instructional design), or Doctor of Pharmacy (PharmD) /RPh, or equivalent healthcare professional qualification
• 5+ years of experience in pharmacovigilance training, education, or capability development (e.g., curriculum design, training delivery, training program oversight, and application of adult learning principles to enhance engagement and knowledge retention)
• Ability to design, deliver, and measure training effectiveness using data, performance metrics, quality trends, and inspection outcomes, with a focus on knowledge retention and application of adult learning methodologies
• Proficiency in pharmacovigilance systems and understanding of Learning Management Systems (LMS), with the ability to optimize training delivery, tracking, and reporting, including support for modern learning approaches (e.g., microlearning, spaced reinforcement)
• Experience in developing and assessing training effectiveness using metrics, quality trends, or audit/inspection outcomes
• Experience working in a healthcare professional role (e.g., nursing, pharmacy) or applying clinical knowledge to pharmacovigilance activities
• Experience implementing innovative or modern learning strategies (scenario-based training, experiential learning, spaced reinforcement) within a regulated environment

Responsibilities

• Lead the GPS Training program, including curriculum development, training assignments, training compliance, and document management, ensuring application of adult learning principles.
• Lead the end-to-end strategy for GPS training programs, ensuring alignment with global regulatory requirements, internal procedures, and adult learning principles.
• Design and implement innovative, scalable, and fit-for-purpose training approaches grounded in adult learning theory.
• Establish and maintain training effectiveness metrics, incorporating evaluation of knowledge retention and application, and report insights to leadership.
• Lead training initiatives, such as conducting training needs analyses based on deviations, CAPAs, audit findings, process changes, and regulatory updates.
• Drive continuous improvement of training curricula using industry insights, inspection/audit data, and adult learning methodologies.
• Oversee training compliance for GPS staff, vendors, and partners, including identification and escalation of non-compliance.
• Lead company-wide adverse event (AE) and serious adverse event (SAE) training for commercial and clinical programs.
• Partner with the Training and Development function to monitor training compliance and manage escalation for GPS staff and vendors.
• Partner with functional subject matter experts (SMEs) to translate complex PV processes into practical, engaging, and learner-centered training content.
• Serve as QTC support for quality records, including deviations, CAPAs, and effectiveness checks.
• Support root cause analysis (RCA) and CAPA development, ensuring alignment with training-related risk mitigation.
• Contribute to tracking and trending of quality events to identify opportunities for continuous improvement.
• Provide cross-functional coverage to ensure continuity of QTC operations.
• Contribute to the development, tracking, and reporting of compliance, quality, and performance metrics for the GPS Quality, Training and Compliance team.
• Support identification and escalation of compliance risks, and assist in implementing recommendations to strengthen quality management systems.
• Support inspection and audit readiness activities across pre- and post-audit phases, including oversight and tracking of CAPAs.
• Serve as a QTC subject matter expert (SME) during audits and inspections, supporting responses and providing training-related expertise.
• Act as the training SME or contributor for GPS quality events, including support of RCA and CAPA development.
• Contribute to the development and maintenance of systems and processes supporting the inspection and audit lifecycle.
• Support the management, development, and harmonization of GPS governing documents (e.g., SOPs, guidance documents, templates).
• Partner with GPS functional leadership to identify the need for new or revised procedures, and ensure appropriate implementation and associated training.
• Drive alignment between procedural updates and training implementation to ensure effective adoption and sustained compliance.
• Perform other duties as assigned.

Benefits

• medical / dental / vision / prescription coverage
• employee wellness resources
• savings plans (401k and ESPP)
• paid time off & paid parental leave benefits
• disability benefits