Job Description
Putnam Associates is seeking a detail-oriented Pharmacovigilance Specialist to support PV compliance and reporting. This role involves direct support to case teams, improving firm-wide PV processes, and ensuring adherence to quality standards and timelines. Responsibilities include case management, pre-audit preparations, monitoring client PV agreements, training staff, and managing compliance training. The specialist will also assist with AE/SAE reconciliation, technical issues on PV platforms, and risk mitigation.
Good To Have:
- Bachelor’s degree in Business, Marketing, or Social Sciences preferred
Must Have:
- Support the execution and management of pharmacovigilance (PV) compliance and reporting processes.
- Provide direct support to case teams.
- Focus on improving Putnam’s pharmacovigilance and compliance processes as a firm.
- Provide support to PV Manager on case management activities to ensure AE information is processed according to documented timelines and quality standards.
- Support PV Manager with pre-audit preparations and data organization.
- Help monitor the implementation of processes outlined in client PV agreements and safety management plans.
- Train consulting staff on new and updated client PV processes.
- Provide guidance and support in the review and submission of Adverse Events (AE)/SAE reconciliation, and other quality requirements.
- Manage, track and coordinate compliance training for consulting team members across various clients.
- Provide content guidance, as needed, for all safety documentation.
- Train third-party vendors on client’s PV compliance standards.
- Help consultants address technical issues with PV client platforms.
- Field various client and internal QC questions.
- Support the building of processes that will allow for a streamlined adherence to client PVAs.
- Aid/expedite market research fielding approval with clients.
- Assist with new hire onboarding PV training and documentation of completion.
- Assist with creation/revision of appropriate quality and compliance policies, SOPs, processes, and best practices as needed.
- Partner with various stakeholders to proactively identify and mitigate compliance risks, and escalate critical compliance risks to PV Manager.
Description of Role-- Pharmacovigilance Specialist
Putnam Associates is seeking a talented and detail-oriented individual to support the execution and management of pharmacovigilance (PV) compliance and reporting processes. The individual in this role will provide direct support to case teams and will focus on improving Putnam’s pharmacovigilance and compliance processes as a firm. The role requires a team-player who thrives in a fast-paced, deadline-driven environment and takes a proactive approach to problem solving. This role will operate within Putnam’s Consulting Operations and Support team, which is tasked with providing support to Putnam consulting teams.
Pharmacovigilance Specialist Tasks
- Provide support to PV Manager on case management activities to ensure AE information is processed according to documented timelines and quality standards
- Support PV Manager with pre-audit preparations and data organization
- Help monitor the implementation of processes outlined in client PV agreements and safety management plans
- Train consulting staff on new and updated client PV processes
- Provide guidance and support in the review and submission of Adverse Events (AE)/SAE reconciliation, and other quality requirements
- Manage, track and coordinate compliance training for consulting team members across various clients
- Provide content guidance, as needed, for all safety documentation.
- Train third-party vendors on client’s PV compliance standards
- Help consultants address technical issues with PV client platforms
- Field various client and internal QC questions
- Support the building of processes that will allow for a streamlined adherence to client PVAs
- Aid/expedite market research fielding approval with clients
- Assist with new hire onboarding PV training and documentation of completion
- Assist with creation/revision of appropriate quality and compliance policies, SOPs, processes, and best practices as needed
- Partner with various stakeholders to proactively identify and mitigate compliance risks, and escalate critical compliance risks to PV Manager
Background / Requirements
- 2-5 years of relevant experience
- Bachelor’s degree in Business, Marketing, or Social Sciences preferred
- Comfort working with Excel, PowerPoint, and MS Word
- Outstanding attention to detail and organizational skills
- Excellent project management skills
- Strong analytical skills and ability to use data to develop business insights
- Ability to succeed in a fast-paced, growth-oriented environment
Don't meet every job requirement? That's okay! Our company is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.
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