Manager, Drug Safety Operations
and its subsidiaries develop, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, consumers and caregivers.
At Purdue Pharma and our subsidiaries, you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work. We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We welcome the opportunity to have you on our team!
Our Commitment to Diversity, Equity, Inclusion and Belonging
We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines.
Diversity, Equity, Inclusion and Belonging are important to our business and are articulated in our People and Culture strategy and represent an important component of our goals and objectives. As we build an exciting path forward, we strive to create an environment where everyone can bring their best and true self to work each day. Embracing different backgrounds, ideas, and viewpoints are valued and encouraged. We believe that Respect is grounded in our Values of Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other. Together we make an impact on our growth, our culture, and most importantly, patients.
This position supports the Executive Director, Safety Operations, Standards & Compliance in leading the Drug Safety Operations function and day-to-day oversight of third-party case processing provider. The Manager, Drug Safety Operations has responsibility for overseeing US adverse event case processing and ensures processes and procedures meet global safety reporting requirements and complaints with PVA agreements. The position manages assigned staff in performing case management responsibilities and achieving department objectives accurately and efficiently. The role has a key role in representing the US Drug Safety Operations department to the internal and external partners. The position contributes innovative ideas and implementation plans for further development and improvement of Drug Safety Operations processes.
- Manage and supervise assigned staff and Operations processes, including:
- Resource planning, recruiting, and performance management
- Training and development
- Work prioritization, resource allocation and delegation
- Initiate and/or oversee corrective action plans
- Issue resolution / escalation
- Monitor the work of outside Contract Research Organization (CRO) resources as well as contractors, including activities such as:
- Compliance with contractual agreements and applicable DS&P SOPs and Conventions
- Monitoring of case quality oversight metrics and CRO performance
- Issue / problem resolution with CRO management
- Provide education, training, and feedback to DSO and CRO resources
- Identification of training issues and propose resolutions
- Communication of CRO management activities with DS&P management
- Lead the development, implementation, and maintenance of standard operating procedures (SOPs), job aids, work instructions, training materials and other DS&P work procedures to ensure compliance with ICH guidelines and local regulatory requirements as well as ensure procedural details are applied and followed in operational DSP and outsourced activities.
- Ensure compliance with relevant policies, procedures, regulatory requirements and PV agreements.
- Review group quality, compliance and performance metrics
- Identify issues, analyze root causes, define improvement plans.
- Initiate and/or oversee corrective action plans.
- Provide operational support for generation and timely submission of aggregate reports such as PSURs, PADERs, PBRERs and IND annual reports to ensure regulatory compliance.
- Represent DS&P on company-sponsored clinical trial operational teams. Author/review safety study management plans, assist in clinical database setup, support training of external vendors on AE reporting, & ensure procedures are in place for the timely and accurate reporting of clinical trial SAE reports into the safety database.
- Perform the role of company medical coding Subject Matter Expert. Responsibilities include:
- Management of Medical and Drug Coding Dictionary global contracts and safety database updates for coding.
- Provide ad hoc coding support for Aggregate reports, DS&P database queries and Purdue clinical research activities.
- Participate in internal/external audits and regulatory inspections as required.
- Collaborate with cross-functional departments, PV partners, CROs and vendors on global projects and initiatives, and to resolve operational issues.
- Contribute to development and maintenance of Safety Data Exchange Agreements (SDEAs), PV agreements, Statement of Work (SOW), and monitor compliance with PV agreements.
- Troubleshoot and rapidly resolve operational questions/issues.
- Responsible for leading, and implement potential improvement initiatives and process efficiencies.
- Provides input and assists in the development of department objectives.
- Stay up to date with regulations, guidance and ensure they are implemented on a timely basis to avoid compliance gaps.
- Perform other duties as assigned and required
Education and Experience:
- Bachelor’s or higher degree in healthcare or life sciences
- An advanced degree such as MD, PharmD, RN or BSN is preferred
- Minimum 5 years of experience within pharmaceutical industry and/or clinical environment required
- Minimum 3-5 years Drug Safety experience required
- Minimum 5 years managerial experience required. CRO management/oversight experience preferred
Necessary Knowledge, Skills and Abilities:
- Working understanding of regulations and FDA, ICH, and GVP guidance
- Product knowledge (labeling, therapeutic class)
- Advanced knowledge of scientific terms and medical terminology
- Computer skills and understanding of Safety Databases; Argus Safety experience preferred
- Advanced knowledge of MedDRA and WHO drug dictionary
- Proficiency with basic MS Office applications
- Written and verbal communication skills; interpersonal skills
- Personnel management, including recruiting, coaching and training, evaluating performance, providing feedback, development planning
- Organization skills; analytical thinking
- Time management and ability to prioritize workload
- Quality orientation: attention to detail, accuracy
- Leading meetings
- Understanding of communicating and training concepts
- Ability to influence others
- Understanding of documentation requirements in a regulated environment
- Ability to work without appreciable direction toward long-range goals and objectives
Who we are looking for?
Someone who is...
- Highly effective with strong written and oral communication skills
- Experienced in functioning with minimal oversight
- Comfortable functioning in a matrix environment that interacts with functional groups within the company as well as internationally
- Energetic and enthusiastic with the potential to grow in an evolving and growing organization
Supervisory Responsibilities (if applicable):
- Will have direct supervision of a Drug Safety Operations Associate
- Manages the teams from external CRO and independent contractors
Our Company is an Equal Employment Opportunity/Affirmative Action employer, Minority/Female/Disability/Veteran, encouraging diversity in the workplace. Qualified applicants will receive consideration for employment without regard to their race, gender, national origin, religion, color, age, sex, sexual orientation, pregnancy, marital status, gender identity or expression, genetic information, disability, veteran or military status, or any other characteristic protected by local, state, or federal law.
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- Equal Employment Opportunity is the Law (EEO)
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- Family and Medical Leave Act (FMLA)
- Employee Polygraph Protection Act (EPPA)
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- Job Family Medical Affairs
- Pay Type Salary
- Required Education Bachelor’s Degree
- 201 Tresser Blvd, Stamford, CT 06901, USA