Website Lenox Executive Search
Lenox Executive Search is seeking a Pharmacovigilance Scientist to serve as a Project Manager in the Signal Management Center of Excellence of a leading global pharmaceutical company in Cambridge, MA. This is a 6++ month contractual role with potential to extend or convert, Position is Remote for now and slated to become onsite post Covid. Possibility exists to remain as a Remote position.
Note: Position requires full Covid vaccination.
This position is responsible for critical activities in support of Signal Management in line with Global Patient Safety Evaluation’s (GPSE) mission to ensure patient safety. This position supports the development, implementation and maintenance of the applications and tracking systems, and helps drive business and operational efficiency. Primary responsibilities include but are not limited to:
• Provides expert project/program management and leadership skills to ensure internal, cross-functional, cross-divisional project plans are in place for the Signal Management Center of Excellence related initiatives.
• Provides project management of the Signal Management processes (e.g., KPIs, metrics, dashboards).
• Supports key initiatives that have cross-functional impact and that are critical to Signal Management business objectives.
• Ensures Signal Management processes meet highest standards by working cross functionally and supporting the development of required processes (e.g., with Global Regulatory Affairs, Quantitative Sciences).
• Promotes interactions with other PV functions including QPPV, Global Medical Safety to ensure processes are regularly updated and are fit for purpose.
• Collaborates with GPSE sub-functions and with partners vendors engaged on Signal Management activities.
• Supports projects/initiatives and change-management activities.
• Identify and execute opportunities for infrastructure enhancements and efficiencies, including process improvement.
• Supports interactions with other relevant functional areas both within and outside of global PV to ensure standards are maintained.
• Supports vendor engagement by working with stakeholders to identify and support implementation of opportunities for efficiency gains.
• Utilizes project and program management expertise to drive project teams to achieve clarity on issues and focus on effective contingencies; interface with management and influence decision-making, monitor progress, gaps, risk management to ensure progress and business continuity.
• Assists in the development of processes and job aids as it relates to signal management.
• Any other tasks assigned by manager to assist in departmental activities
• Bachelors required. Post-graduate degree or equivalent (Master’s Degree/MBA) preferred.
• Bachelors with minimum 6 years’ experience in pharmaceutical/biotech industry (at least 4 years’ experience in pharmacovigilance, clinical research, regulatory or alliance management role).
• Post-graduate degree or equivalent (Master’s Degree/MBA) with minimum 4 years’ experience in pharmaceutical/biotech industry (at least 3 years’ experience in pharmacovigilance, clinical research, regulatory or alliance management role).
• Experience in program and/or project management, preferably in the Pharmaceutical or Biotech industry in clinical development, regulatory affairs, pharmacovigilance, or related function.
• An understanding of and experience in the drug development process, including post-marketing and life-cycle management, with a focus on drug safety/pharmacovigilance.
• Project management abilities and insights required to work productively in a global company and across multiple functions.
• Strong ability to proactively identify areas for process improvement and lead infrastructure-related projects efficiently and within given time constraints.
• Ability to proactively identify and anticipate project risks, including those associated with non-adherence to the regulations, and a keen understanding of when to escalate issues quickly and efficiently.
• Capacity to manage time and priority constraints as well as manage multiple priorities simultaneously
• Excellent time management skills.
• Ability to lead meetings and teleconferences, both internally as well as externally to technical groups and vendors.
• Excellent oral and written communication skills.
• Ability to handle confidential information appropriately.
• Excellent presentational skills.
• Excellent level of computer literacy , including EXCEL, MS Project, and Visio.
• Some domestic and international travel may be required on an infrequent basis.