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Manager, Pharmacovigilance Operations Lead

Company: The American College of Radiation Oncology
Location: Cambridge
Posted on: September 15, 2020

Job Description:

(Contract) Manager, Pharmacovigilance Operations Lead

(Contract) Manager, Pharmacovigilance Operations Lead Description

The Role:

Join Moderna Therapeutics enthusiastic and collaborative team and make a significant impact on the overall success of our innovative messenger RNA drug development programs. By joining our Pharmacovigilance team, the Pharmacovigilance Operations Lead will provide critical PV quality and operational support throughout the life-cycle of all Moderna products. In this new role, the successful candidate will be responsible for the oversight of PV activities including vendor management, ongoing process improvement and aggregate reports. The anticipated time frame for this assignment is twelve months.

Here s What You ll Do:

Reporting to the Senior Director, Pharmacovigilance, the PV Operations Lead will be responsible for:

Lead and manage PV Operations activities across the company platform.

Establish successful working relationships with and provide oversight to PV Vendors/CROs with day-to-day PV operational activities for Moderna s investigational products including but not limited to ICSR activities and aggregate reports.

Assist with writing/review and maintenance of Pharmacovigilance Agreements

Ensure overall performance of the department and compliance with global regulatory requirements by assisting in implementation of applicable SOPs, processes, metrics, and monitoring of performance and compliance.

Responsible for implementing PV related activities within the scope of PV operations as outlined in relevant agreements with Business Partners and/or other parties, as required

Collaborates with other key stakeholders to provide expertise and guidance for interdepartmental and cross-functional team activities, including process improvement standards and metrics.

Liaises with financial / project management for budget planning.

Provide Subject Matter expertise (SME) during audits and inspections in the areas of case processing/case management activities, literature monitoring, metrics, vendor oversight, etc.

Here s What You ll Bring to the Table:

Bachelor s required. Candidates with advanced scientific degrees and extensive PV experience preferred.

Minimum 5 years recent experience in the pharmaceutical industry preferably in PV, or relevant scientific/clinical, or pharmaceutical experience

Working knowledge global pharmacovigilance regulations

Knowledge of MedDRA terminology and its application

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

About 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 can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna 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, cardiovascular diseases, and autoimmune and inflammatory 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, 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) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science s list of top biopharma industry employers for the past five years. 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.

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.

#LI-DNIR2907

Job Information

Job ID: 54609408

Location:

Cambridge, United States

Position Title: (Contract) Manager, Pharmacovigilance Operations Lead

Company Name: Moderna Therapeutics

Job Function: Clinical,

Operations,

Pharmacovigilance

Please refer to the company's website or job descriptions to learn more about them.

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100 Winners Circle, Suite 300 Brentwood, Tennessee 37027 (978) 624-4594

Keywords: The American College of Radiation Oncology, Cambridge , Manager, Pharmacovigilance Operations Lead, Other , Cambridge, Massachusetts

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