Director, Pharmacovigilance Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate strategies for pharmacovigilance (PV) operations and assist the PV Head in executing the vision and strategy for the PV function.

• Provide strategic guidance for global pharmacovigilance operations, encompassing case management, vendor supervision, and aggregate reporting.

• Oversee the implementation of the MPLT safety system, including safety databases and processes, ensuring regulatory compliance in ICSR case processing.

• Manage PV vendor relations and contract oversight, including third-party CROs and partners.

• Supervise safety-related alliance management, including Safety Data Exchange Agreements (SDEAs).

• Coordinate information and data exchange between clinical and PV vendors, collaborating closely with Clinical Operations.

• Ensure quality and compliance in ICSR case processing and reporting on key performance indicators (KPIs).

• Develop, review, contribute to, and maintain current ICSR case-processing standard operating procedures (SOPs), forms, and safety management plans (SMPs).

• Collaborate with safety surveillance and cross-functional teams to facilitate the timely dissemination of safety deliverables.

• Partner with the Quality team to lead PV contributions during audits and inspections.

• Manage deliverables and projects within the PV function.

• Oversee the contributions of the PV function to Trial Master Files (TMFs).

• Administer the PV budget and vendor resources effectively.

• Mentor and coach associates in PV Operations.

• Report directly to the Vice President of Pharmacovigilance.

⛳️ Requirements

• A healthcare professional degree (e.g., RN, BSN, PharmD) or an advanced degree (Master's/PhD) in biomedical sciences, pharmaceutical sciences, or a related life science field.

• At least 8 years of experience in pharmacovigilance within the biopharmaceutical industry, with a minimum of 3 years in a leadership role in PV operations.

• Proficient in conducting safety data reviews, vendor management, preparing aggregate reports, and developing signal detection and risk management plans for investigational and/or post-marketed products.

• Experience with MedDRA and drug coding reviews.

• Proven expertise in global PV regulations, Good Pharmacovigilance Practices (GVP), ICH guidelines, safety systems, and drug development processes.

• Familiarity with PV processes for individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections.

• Demonstrated project management capabilities in a dynamic organization within the PV realm.

• Outstanding communication skills and the ability to collaborate across functions.

• Strategic thinker with the capability to convert complex safety data into actionable insights for regulatory and clinical decision-making.

• Ability to thrive within a growing organization and contribute to its evolution over time.

• Capacity to engage in open, constructive, and ongoing dialogue with company stakeholders, fostering equality and mutual respect.

• Highly motivated, self-sufficient, and reliable.

• Strong commitment to MapLight's Core Beliefs and Values.

• Willingness to travel as required, up to 10%, for corporate and departmental meetings.

🏝️ Benefits

• Opportunity for annual bonuses.

• Comprehensive medical insurance.

• Dental coverage.

• Vision care.

• Life insurance policy.

• Accidental Death and Dismemberment (AD&D) insurance.

• Short-term disability benefits.

• Long-term disability coverage.

• 401(K) plan with matching contributions.

• Stock options available.

• Flexible non-accrual paid time off.

• Parental leave benefits.

• Travel opportunities as required (up to 10%) for corporate and departmental meetings.