Director, Pharmacovigilance Scientist

Moderna Theraputics Cambridge , MA 02138

Posted 2 months ago

The Role:

Join Moderna Therapeutics' enthusiastic and collaborative team and make a significant impact on the overall success of our novel messenger RNA approach to drug development. Reporting to the Senior Director of Pharmacovigilance, the PV Scientist will be a key contributor focusing on strategic input, support in clinical trial, perform signal management activities 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 in case management and aggregate reports.

  • 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 and regulatory activities.

  • 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 Pharmacovigilance Agreements.

  • Oversight of signal evaluation/safety monitoring activities.

  • Assure oversight for the review of aggregate safety data to ensure accuracy, integrity and completeness.

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 is preferred

  • 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

Here's What We'll Bring to the Table:

  • Daily on-site catered lunches

  • Company-provided iPhone

  • Free parking, monthly subway pass or a subsidized commuter rail pass

  • Free annual corporate membership to Bluebikes

  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP

  • Flexible Spending Accounts for medical expenses and dependent care expenses

  • 16 weeks of 100% paid parental leave for all new parents

  • 16 weeks 100% paid family caregiver leave

  • 20 weeks 100% paid medical leave

  • Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)

  • Adoption assistance and discounts to local childcare centers, as well as access to care.com

  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately

  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability

  • Voluntary legal assistance plan

  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

Why join Moderna:

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been named a top employer by Science for the fifth year in a row. To learn more, visit www.modernatx.com.

Our Mission:

Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

#LI-KF1

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.


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Director, Pharmacovigilance Scientist

Moderna Theraputics