Associate Director, Pharmacovigilance Scientist

Company: Moderna Theraputics
Location: Cambridge
Posted on: May 13, 2022

Job Description:

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. By joining our Clinical Safety Science Team, the Associate Director, Clinical Safety Scientist is responsible for performing core pharmacovigilance activities in partnership with the Global Medical Lead by supporting the process for signal management activities and analyses, aggregate report contributions, responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial activities.

Here's What You'll Do:

* Partner with the PV physicians to provide scientific/clinical expertise, strategic input, and support for deliverables and activities associated with signal management activities, management of potential safety issues, evaluation of databases for safety signals, and drafting of responses to regulatory inquiries/IRB/EC requests on product safety issues for assigned product(s) during all phases of the product life-cycle


* Effective communication skills for close collaboration with colleagues from other functions including but not limited to Clinical Development, Biostatistics, Regulatory Affairs, and Medical Affairs


* Review safety sections and provide safety content for study protocols, statistical analysis plans, eCRFs, ICF and other clinical study-related documents as well as standard design of tables, figures, and listings for safety data from clinical studies


* Support updates to Investigator Brochure, Company Core Safety Information, and other Reference Safety Information


* Review and prepare adverse event data, literature, and other safety-relevant data for the purpose of signal analyses


* Contribute to safety contents for aggregate reports and risk management plans



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

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


* Minimum 6 years pharmacovigilance experience including safety signal management, clinical trial support and aggregate report


* Expertise in Argus Safety Database, MedDRA, Sharepoint, Microsoft Office, and Excel.


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


* Excellent time management skills


* 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 in global pharmacovigilance regulations



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
* Volunteer time to participate within your community
* Discretionary winter shut down
* Paid sabbatical after 5 years; every 3 years thereafter
* Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
* 401k match and Financial Planning tools
* Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
* Complimentary concierge service including home services research, travel booking, and entertainment requests
* Free parking or subsidized commuter passes
* Location-specific perks and extras!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. 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 and approval 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 autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven 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.

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Keywords: Moderna Theraputics, Cambridge , Associate Director, Pharmacovigilance Scientist, Executive , Cambridge, Massachusetts