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(Contract) Manager, Pharmacovigilance Operations

Company: Moderna Theraputics
Location: Cambridge
Posted on: June 10, 2021

Job Description:

The Role:

Moderna is seeking a Pharmacovigilance Operations Manager to provide key operational support throughout the lifecycle of Moderna's products. The successful candidate will aid Moderna's PV Operations leadership in the oversight of PV activities including, but not limited to, vendor oversight and oversight of ICSR and aggregate reports.

Here's What You'll Do:

  • Provide expertise on PV Operations processes to cross-functional teams (i.e. Data Management, Clinical Development, Medical Affairs, etc.), as required

  • Review and provide input for data entry conventions and specifications for the global safety database.

  • Aid in the development and maintenance of training materials for case processing teams.

  • Conduct and support PV Operations activities to ensure compliance with regulatory requirements and maintain regulatory inspection readiness in collaboration with Quality Assurance.

  • Monitor Clinical Trial SUSAR workflow, reviewing the quality of reports and ensuring timely PV medical review.

  • Assist the Clinical Safety and Risk Management team with maintenance of AE Data Collection forms for Safety follow-up and List of Expected Events.

  • Exchange of safety data with partners, as required.

  • Collaborate with Data Management and Clinical Development teams by reviewing and providing input into documentation and guidelines for clinical trials that impact PV activities, including Case Report Forms, CRF Completion Guidelines, SAE and Safety Events Reconciliation plans, etc.

  • Contribute to development of safety-related SOPs and guidelines and conduct training.

  • Contribute to the collection, organization, and presentation of all required global PV compliance metrics including vendor and partner oversight metrics.

  • Assist with preparation and execution of inspection activities during Regulatory Authority inspections and internal audits.

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

  • Bachelor's degree or higher in a life science required - healthcare professional preferred

  • Minimum 5 years recent experience in pharmacovigilance/drug safety, or relevant scientific/clinical, or pharmaceutical experience

  • Working knowledge of global pharmacovigilance regulations

  • Knowledge of MedDRA terminology and its application

  • In depth knowledge of safety database structure and use, including ICH E2B reporting format

  • 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

  • Outstanding written and verbal communication skills with the ability to build successful relationships with cross-functional team members

About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

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-DNI

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Keywords: Moderna Theraputics, Cambridge , (Contract) Manager, Pharmacovigilance Operations, Other , Cambridge, Massachusetts

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