What You’ll Do:

Reporting to the Senior Director, Patient Safety and Pharmacovigilance (PSPV) Operations, the Manager, Patient Safety and Pharmacovigilance Operations will support the day-to-day safety vendor contracted activities and ensure that day-to-day activities are aligned with company standards and regulatory requirements, with a strong focus on quality, compliance, and continuous improvement.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Act as a subject matter expert on emerging global guidelines and regulations, assessing impact on existing procedures, and recommending updates
• Support PSPV Operations in the development and maintenance of safety vendor documentation (e.g., SMP, SAE/AESI, Pregnancy Reporting forms, etc.)
• Responsible for the oversight of the safety vendor ICSR case processing and reporting activities (e.g., ensuring high quality and compliant case processing and submission activities including narrative writing, coding (MedDRA), query resolution, reports generation, study closure, etc.), SAE Reconciliation support, and safety vendor metrics (e.g., KPIs and KQIs, etc.) as defined in the SMP
• Act as primary day-to-day liaison with the safety vendor project manager and team leads to ensure efficient case workflow to meet PSPV and alliance partner obligations
• Support in-line and/or retrospective case quality review (e.g., to assess coding accuracy, narrative completeness, data integrity, regulatory compliance, etc.)
• Develop and maintain a robust and easily navigable PSPV SharePoint repository
• Document, track, and escalate issues or quality trends as per process and the PV Quality Agreement. Identify process or quality gaps and contribute to effective, stage appropriate, and compliant solutions
• Collaborate with the safety vendor to provide timely delivery of internal and external safety database data extract requests and support safety database activities (e.g., database updates, processes, new study configurations, access issue escalations, case processing conventions, system implementation/transitions, etc.)
• Contribute to controlled document development and maintenance (e.g., SOPs, WIs, SAE/pregnancy forms, SMPs, etc.) and support inspection readiness activities
• Support PSPV Aggregate reporting activities (e.g., signal detection, DSUR, risk management, literature review, etc.), as required
• Promote a culture of compliance, operational excellence, and continuous improvement within the PSPV team and ensure effective communication with internal and external shareholders
• Empowered to drive and/or support initiatives to standardize procedures, improve efficiency, and manage change within operations and PSPV as a whole
• Support TMF filing activities
• Participate in internal and external team meetings (e.g., clinical study team meetings, safety vendor governance activities, alliance meetings, etc.)

Required Qualifications:

• Minimum of 6+ years of experience in Drug Safety/Pharmacovigilance Operations within the pharmaceutical or biotechnology industry
• Working knowledge of global PV regulations, including FDA and ICH guidelines
• Demonstrated working knowledge of safety databases (e.g., Argus), especially reports generation, PV dashboard, etc
• Demonstrated ability to work collaboratively in a fast-paced, cross-functional, and matrixed environment with strong organizational, time management, and project prioritization skills. Excellent verbal and written communication and interpersonal skills
• Prior PV Operations and safety vendor management experience required
• Adaptable to changing priorities
• Proficient computer skills, including Microsoft Word and Excel
• Must be able and willing to travel on occasion

Preferred Qualifications:

• Prior PV audit and/or inspection experience a plus
• Safety database data retrieval experience preferred

Education:

• Bachelor’s degree in Life Sciences (or equivalent experience) or a related field required.  (BS, RN, preferred)