Position Title: Project Manager Pharmacovigilance
Work Location: Cambridge MA USA 02142
Assignment Duration: 06 Months (Possibility of extension)
Work Arrangement: Hybrid, 5 days per month
 
Position Summary: Partners with our organization Safety Board (TSB) Chair to enable its operational excellence
 
Key Responsibilities:

• Provides project management leadership to facilitate TSB processes and activities including escalation and company-wide communication
• Ensure training on TSB processes, and continuous improvement by incorporating learnings into ways of working and performance measurement
• Functions as Business Process Owner (BPO) for Data Monitoring Committee (DMC), Internal Review Committee (IRC), and First in Human Committee (FiH)
• Takes the lead on additional assigned projects to drive organizational goals and operational excellence
• Acts as SME overseeing the Reference Safety Information (RSI) CAPA-related activities
• Oversees PSPV business continuity plan, monthly department meetings, and PSPV Satori Council
• Partners with Global Project Leaders, Global Safety leads, PSPV Therapeutic Areas Heads, and other senior leaders to collect and analyze information supporting the decision-making process to trigger a TSB interaction (e.g. ad hoc Meeting, Milestones Review or Forum)
• Collaborate with the TSB Chair, PRC office & PSPV Therapeutic Area Heads to initiate and triage TSB interactions in alignment with established governances and processes (e.g. Other Important Safety Information, Safety Management Team, GLOC, QAM, PCMC).
• Oversees logistics and project management of TSB activities
• Maintains TSB materials in centralized location, ensuring adequate access to information such as pre-read, meeting minutes, and closeout of all action items
• Maintains TSB processes (e.g. SOP, training slides, playbook), and oversees training to ensure understanding of TSB readiness and operating model
• Expedites escalation, decision making and communication related to TSB activities.
• Analyses and reports TSB performance based on strategic and business goals, working with TSB Chair to measure against Key Performance Indicators (KPIs).
• As a member of the Strategy and Operations Team, provides input to key strategic & portfolio activities that may include:
• Project management support for PSPV initiatives, change-management activities and organization of department meetings.
• Supports business analytics and key initiatives enabling operational deliverables aligned with organizations goals.
• Supports PSPV business continuity plan and PSPV Satori Council
• Foster and maintain an engaging culture and continuously improve PSPV’s ways of working.

Qualifications & Experience:

• Bachelor’s Degree Science or business-related field
• Advanced degree in science or business is desired
• 5 years direct experience in the pharmaceutical industry or related field required
• Previous experience influencing senior-level management and key stakeholders is a plus
• Health care business acumen with a comprehensive understanding of the pharmaceutical industry
• Demonstrated ability to work across functions, regions, and cultures
• Demonstrated leadership with the ability to inspire, motivate and drive results
• Demonstrated strong project management capabilities
• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
• Demonstrates leadership presence and confidence across all levels of the organization, including Executive level leaders

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 90.00/hr.