What You’ll Do: 

The Director, Pharmacovigilance (PV) Operations will lead the strategy, planning, execution, and maintenance of safety databases and outsourced PV activities through partners and contract research organizations. Reporting to the Vice President, Pharmacovigilance, this person will oversee the collection, evaluation, and reporting of safety data from clinical trials, shaping the company’s safety governance framework and supporting strategic decisions related to PV operations across programs. 

Responsibilities:

• Develop strategy for PV operations and support PV Head in the implementation of strategy and vision for PV function
• Provide strategic leadership for global pharmacovigilance operations, including case management, vendor oversight, and aggregate reporting.

• Manage the implementation of MPLT safety system (safety database and process) for regulatory compliant ICSR case processing
• Oversight of PV vendor and contract management (e.g. third party CRO, partners)
• Oversight of alliance management related to safety (SDEAs)
• Manage flow of information and data between clinical and PV vendor in collaboration with Clinical operation (e.g. PV mailbox)
• Oversight of quality and compliance for ICSR case processing and reporting (KPI)
• Develop, contribute, review and maintain up to date ICSR case processing SOPs, forms, SMPs etc.
• Liaise with safety surveillance and cross-functional teams to support for timely dissemination of safety deliverables
• Collaborate with Quality function and lead PV contributions for audit and inspections
• Project management for PV functional deliverables
• Oversight of PV functional contributions to TMFs
• Manage PV budget and resources for PV vendor
• Coach and mentor PV operation associates

We consider these behaviors we seek in all ML employees.

• You can participate and work effectively with multiple cross-functional teams.
• You have strong interpersonal skills and understanding relationships are key to being successful.
• You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.
• You’re a team player who is willing to roll up your sleeves and get the job done.

 

Qualifications:

• Health care professional degree (e.g. RN, BSN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or related life science.
  • Preferred: Post-graduate training in business management or project management (MBA, PMP)
• Minimum 8 years of pharmacovigilance experience within the biopharmaceutical industry with at least 3 years in leading PV operations.
  • Preferred: Experience in neuroscience, psychiatry or neurodegenerative disease area
• Competence in conducting safety data reviews, vendor management, preparation of aggregate reports, signal detection and risk management plans for investigational and/or post marketed products.
• Experience with MedDRA and drug coding reviews.
• Demonstrated expertise in global PV regulations, GVP and ICH guidelines, safety systems, and drug development processes.
• Experience in PV processes for individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections.
• Demonstrated PV project management skills in a fast-paced organization
• Exceptional communication and cross-functional collaboration skills.
• Strategic thinker with the ability to translate complex safety data into actionable insights for regulatory and clinical decision-making.
• Able to work within a growing organization and to help the organization evolve over time.
• Able to engage in an open, constructive and continuous dialogue with the Company’s stakeholders based on equality and mutual respect.
• Highly motivated, self-driven and dependable.
• Committed to MapLight's Core Beliefs and Values.

Location: This is a hybrid position with onsite at our office in Burlington, MA.

Travel: Ability to travel as needed (up to 10%) for corporate and departmental meetings.

MapLight is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.