Director, Clinical Safety Scientist

at  Moderna

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, experience in Biotech, Pharma or a Clinical Research Organization, including at least 4 years’ experience in vaccine development Pharmacovigilance
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
Knowledge of ICH guidelines relevant to PV and of global PV regulations, including FDA, EMA, MHRA, PMDA, and Health Canada.
Strong analytical skills and an ability to synthesize complex issues into consumable, simple messages to faciliate clear, concise and tangible recommendations and/or actions.
Experience working with management and consulting with key business stakeholders (e.g., Clinical, Regulatory, Medical Affairs), including an ability to influence without authority for greater outcomes.
Excellent collaboration and interpersonal skills, an ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations.
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

THE ROLE:

Reporting to the Senior Director of Pharmacovigilance, the PV Scientist will be a key contributor focusing on strategic safety input, daily support in clinical trial activities, perform trend analysis for signal management deliverables and safety analytical support for all Moderna products throughout the life-cycle.

HERE’S WHAT YOU’LL DO:

Providing therapeutic area PV support for Moderna’s developmental and/or marketed products in close collaboration with senior PV, Clinical and Medical personnel.
Contribute to process improvements that will ensure excellence in global assessment, demonstrating accuracy, consistency and compliance with applicable global pharmacovigilance regulations.
Review and provide PV therapeutic area input for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents.
Represent Pharmacovigilance on global clinical teams and initiatives both within and across functional areas.
Contribute to pharmacovigilance activities including ongoing signal monitoring and regulatory activities.
Facilitate cross-functional Safety Governance meetings, including safety review activities.
Participate in evaluation of potential safety issues in conjunction with senior PV staff, Medical Monitors, and other functional areas as appropriate.
Review and contribute to aggregate safety reports (e.g., DSURs), and Risk Management Plans as required.
Participate in writing of safety input for regulatory submissions and regulatory responses, collaborating with cross-functional areas as appropriate.
Review of aggregate safety data to ensure accuracy, integrity and completeness .
Analyzing data and drafting documents required for safety for Moderna’s investigational products