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About the role
- Operations Related Research Activities Specialist executing pharmacovigilance compliance oversight for market research and patient support programs. Collaborating with stakeholders to ensure compliance and improve processes.
Responsibilities
- Responsible to execute the pharmacovigilance compliance oversight process for market research, patient support programs and non-interventional studies
- Fulfill audit/inspection requests
- Gather and/or generate key performance and compliance metrics
- Address compliance issues as appropriate
- Data Analysis and Visualization: Serve as the primary monitor of RRA metrics and KPIs
- Collaborate with stakeholders to create and monitor meaningful digital dashboards that enable clear interpretation and data-driven decision making
- Review and approve Market Research, Patient Support Programs, and/or non-interventional studies program within defined system per documented procedures
- Make timely decisions to prevent noncompliance or address compliance issues
- Maintain and compile proper documentation of compliance activities
- Ensure accurate data within the system to generate key performance and compliance metrics
- Review compliance reports and other relevant data to inform decision-making on actions that need to be taken to prevent noncompliance and/or resolve issues
- Development of oversight reports
- Identify potential compliance risks within the organization and work with management to develop strategies and controls to mitigate those risks
- Perform reconciliation of safety data against the safety database
- Liaise with Global Medical Safety Organization and suppliers
- Support noncompliance process including initiating quality investigations and managing records
- Manage 3rd party vendor performing manual compliance tasks
- Collaborate with key functional partners to ensure compliance requirements are met
- Fulfill inspection and audit requests and/or provide subject matter expertise of the compliance oversight process
- Support the implementation of process efficiencies and continuous improvements to decrease cycle time and improve quality of data
- Educate Activity Owners on regulations and policies, providing guidance on compliance-related issues.
Requirements
- Minimally a Bachelor’s degree in Science, Engineering and Technical subjects
- Minimum of 2 years of pharma or clinical experience
- Understanding of relevant regulations, laws, and industry standards
- Familiar with the compliance requirements and be able to interpret and apply them effectively
- Ability to manage issues using deductive reasoning, critical analysis skills and systematic approaches
- Able to analyze data, identify potential compliance risks or noncompliance, and make recommendations based on their findings
- Ability to think in a clear, decisive manner, remains calm under adverse conditions, and reaches independent, reasoned decisions and solutions when required
- Organizational and time management skills to prioritize tasks, meet deadlines, and ensure that compliance activities are carried out effectively
- Able to build positive relationships, demonstrate effective collaboration, and work as part of a team
- Strong influence and negotiation skills
- Critical thinking and leadership skills
- Able to interact with Regulatory Authorities
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
- Excellent computer proficiency e.g MS Office, SAP
- Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution
- Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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