USA – Project Manager Pharmacovigilance
Project Manager Pharmacovigilance
Location: Hybrid, 5 days per month, 650 E Kendall, Cambridge, MA
Pay rate:- $75-80/Hour on W2
6 months contract
Top Skills needed:
Strong organization and project management skills, with ownership of cross functional processes.
Understanding of Pharmacovigilance and impact in the organization.
Proven track-record in working across R&D to support organizational deliverables.
Excellent communication and presentation skills, ability to work with executive leadership.
Ability to collaborate with Team members on cross-functional projects/tasks.
Bachelor s degree in Science or business-related field. Advanced degree preferred. 5 years of experience in the pharma industry or related field.
Position Title: Associate Director, *** Safety Board Office
Function: PSPV Strategy & Operations Office
Department: Patient Safety and Pharmacovigilance (PSPV)
Reports To (Position Title): Head Patient Safety & Pharmacovigilance (PSPV) Strategy &
Operations Office)
Role Level: 4
Job Code: USA_60061487
OBJECTIVE:
* Partners with *** Safety Board (TSB) Chair to enable its operational excellence
* Provides project management leadership to facilitate TSB processes and activities including escalation and company-wide communication
* Ensures 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
ACCOUNTABILITIES:
* Partners with Global Project Leaders, Global Safety leads, PSPV Therapeutic Areas Heads, and other senior leaders to collect and analyse information supporting the decision-making process to trigger a TSB interaction (e.g. ad hoc Meeting, Milestones Review or Forum)
* Collaborates 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).
* Functions as the Business Process owner for Data Monitoring Committee (DMC), Internal Review Committee (IRC) and First in Human Committee (FiH)
o Sets the strategic direction for the process, in coordination with functional experts.
o Leads developing, authoring, maintaining & approving procedural document (SOP), operating model RACI, associated templates / forms, training material, technology capabilities.
o Liaises with other stakeholders (peer function, quality), ensuring cross-function alignment and escalating issues to sponsors.
o Develops global training needs in collaboration with Process, Training and Digital Solutions (PTDS).
* As a member of the Strategy and Operations Team, provides input to key strategic & portfolio activities that may include:
o Project management support for PSPV initiatives, change-management activities and organization of department meetings.
o Supports business analytics and key initiatives enabling operational deliverables aligned with organizations goals.
o Supports PSPV business continuity plan and PSPV Satori Council
o Foster and maintain an engaging culture and continuously improve PSPV s ways of working.
* Acts as SME overseeing the Reference Safety Information (RSI) CAPA-related activities
SCOPE OF SUPERVISION:
NUMBER SUPERVISED WORKERS Direct In-Direct
Employees 0 0
Non-Employees 0 0
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
* 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
PHYSICAL DEMANDS:
* N/A
TRAVEL REQUIREMENTS:
* Some domestic and international may be required on an infrequent basis
Manager Approval
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