Senior Manager, Pharmacovigilance Scientist, Infectious Diseases - COVID

The Role:

Join Moderna and make a significant impact on the overall success of our novel messenger RNA approach to drug development. Reporting to the Head of Pharmacovigilance Operations, the Sr. PV Scientist will provide critical PV quality and operational support for all Moderna products throughout the life cycle.  In this new role, the successful candidate will be responsible for the oversight of PV activities, vendor and alliance management, and ongoing process improvement.

Here's What You’ll Do:

• Providing therapeutic area PV support for Moderna’s developmental products in close collaboration with senior PV, Clinical and Medical personnel.

• Oversight of day-to-day PV operational activities for Moderna’s investigational products.

• Develop and maintain processes that will ensure excellence in global case reporting and assessment, demonstrating accuracy, consistency, and compliance with applicable global pharmacovigilance regulations.

• Oversight of vendor case management and continued process improvement.

• Review and provide PV therapeutic area input for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents.

•      Represent Pharmacovigilance on clinical teams and initiatives both within and across functional areas.

• Assist in usual pharmacovigilance activities including ongoing signal monitoring, benefit/risk assessment, regulatory activities, and interactions.

• Facilitate cross-functional Safety Review Committee meetings, including coordinating aspects of signal evaluation/safety review activities.

• Participate in evaluation of potential safety issues in conjunction with senior PV staff, Medical Monitors, and other functional areas as appropriate.

• Participate in writing of aggregate safety reports (e.g., DSURs), as required.

• Participate in writing of PV input for regulatory submissions and regulatory responses, collaborating with cross-functional areas as appropriate.

• Assist with writing and maintenance of Safety Monitoring Plans and Safety Data Exchange Agreements.

• Oversight of signal evaluation/safety monitoring activities.

• Assure oversight for the review of safety events to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data.

• Involved in contributing to decisions regarding safety evaluation that directly impact departmental performance and regulatory compliance." Collaborates with cross-functional  teams to integrate Pharmacovigilance into relevant documents development, regulatory affairs, and medical affairs." 

Here’s What You’ll Bring to the Table:

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background

• Minimum 8 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 4 years’ experience in PV – experience in vaccine development a plus

• Knowledge of MedDRA terminology and its application

• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety information

• Experience in the preparation and authoring of individual and aggregate safety reports

• Demonstrated ability to develop, execute and follow-through complex projects to completion

• Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

• Independently motivated, detail oriented and strong problem-solving ability

• Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities

• Excellent written and verbal communication skills with the ability to interact across multiple functions

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
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