Head of Pharmacovigilance
Company
Nimbus Therapeutics
Location
Boston MA
Type
Full Time
Job Description
In this role, you will:
- Strategically lead Nimbusā Pharmacovigilance & Drug Safety function and ensure function is an integrated component of Nimbusā development organization
- Responsible for drug safety talent: employees, contractors, consultants, and CROs to ensure a compliant Drug Safety department
- Manage internal employees and external contractors to ensure delivery of quality drug
- Oversee and direct all aspects of global pharmacovigilance & risk management activities for investigational compounds; actively participate in oversight of patient safety in all clinical trials
- Provide a clinical safety view into preclinical / discovery programs in the pipeline
- Oversee the development and maintenance of signal management, safety surveillance and risk management plans for current and future drug development programs
- Serve as the Companyās Subject Matter Expert for all strategic safety related material including providing leadership and guidance for all relevant regulatory authority safety related questions, audits, and inspections
- Ensure expert safety review and leadership of critical development program documents including protocols, ICFs, IBs, IMPDs, CSRs, INDs, CTAs, and NDA/MAA submissions.
- Provide medical review of ICSRs to ensure the accuracy and completeness of AE and SAE cases
- Direct the development, preparation, and compliance of periodic and annual safety reports
- Coordinate the development of departmental policies & SOPs (Standard Operating Procedures) that address that address the processing, analysis and reporting of safety information to ensure proactive surveillance of products in development
- Monitor industry best practices and update current global safety regulations and guidelines for investigational and marketed projects to ensure a compliant Drug Safety department
- Coordinate to ensure training of appropriate personnel and external groups of Pharmacovigilance principles, policies, and SOPs
- Manage the process of identifying, evaluating, and selecting outsourcing vendors.
- Ensures compliance with all applicable laws and regulations and as appropriate, local, and foreign regulatory reporting requirements, for the processing and reporting of adverse events in coordination with Regulatory Affairs
- Provide ad/hoc PV support & guidance for interdepartmental and/or corporate initiatives as needed
- Medical degree (MD or MBBS) with a minimum of 10+ years pharmacovigilance experience within the pharmaceutical or biotechnology industry
- Experience leading medical safety profiles for developmental products, preferably within Oncology and/or Immunology
- Previous experience managing a Pharmacovigilance team
- Oversight experience of company-wide medical safety activities, operational and risk management strategies in pre-marketing environments
- Thorough knowledge of pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities
- Demonstrated knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments
- Ability to exercise sound clinical judgment and communicate complex clinical issues in a scientifically sound and understandable way
- Strong knowledge of common safety databases (Argus, ARISg, etc.)
- Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
A Snapshot of NimbusĀ
OurĀ ScienceĀ Ā
At Nimbus, we design breakthrough medicines. Utilizing our powerful structure-based drug discovery engine, we create potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. With a decade-plus track record of success,Ā weāveĀ built a world-class team in both computationally driven drug discovery and early clinical development while continuing to move the needle for patients.Ā Ā
OurĀ CultureĀ
NimbusĀ is aĀ close-knitĀ companyĀ (our employees areĀ Nimbi, if you are curious!)Ā thatĀ values a fast-paced, entrepreneurial, intellectual-stimulating,Ā and collaborativeĀ environment.Ā We live by our Core Values: Integrity, a Passion for Excellence, Teamwork, and Authentic CommunicationĀ and strive to build a community where we bring out the best in each otherĀ professionally and personally.Ā Ā
Our CompanyĀ
Founded in 2009,Ā Nimbus is a private, growing biotechnology company headquartered in Boston, Massachusetts.Ā Learn more about us by going toĀ www.nimbustx.comĀ
Join Nimbus. We are making a difference and you can too.Ā
At Nimbus, we believe our diversity of backgrounds and experiences strengthens our community and our ability to design breakthrough medicines. We prioritize creating an inclusive, welcoming culture that promotes our core values and encourages every Nimbi to bring their whole selves to their work. Nimbus is proud to be an equal opportunity employer. We value and celebrate all our employees and recognize that our diversity and inclusion are keys to our success. Nimbus is committed to providing equal opportunity for all employees and applicants without regard to race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Nimbus does not accept unsolicited resumes from any source other than directly from candidates.
Ā
Date Posted
12/19/2022
Views
13
Similar Jobs
Fresh Connect Product Manager - About Fresh
Views in the last 30 days - 6
About Fresh is a nonprofit organization that aims to expand access to fresh food empowering individuals to make healthy choices They are seeking a Pro...
View DetailsContracts Manager - Nimbus Therapeutics
Views in the last 30 days - 14
Nimbus Therapeutics is offering a Contracts Manager position with a unique opportunity to contribute to the companys growth and interact with internal...
View DetailsEmail Marketing Performance Analyst - 1-800-FLOWERS.COM, INC.
Views in the last 30 days - 5
The Email Marketing Performance Analyst is responsible for analyzing and reporting on email marketing campaigns helping to guide strategy The position...
View DetailsAccounting Manager - Rue Gilt Groupe
Views in the last 30 days - 6
Rue Gilt Groupe is seeking an Accounting Manager to join their Finance team The role involves working with key business leaders preparing financial st...
View DetailsInbound Business Development Representative - Klaviyo
Views in the last 30 days - 12
Klaviyo values diversity and inclusivity and is committed to empowering creators to own their own destiny The company is looking for a BDR to generate...
View DetailsSr. Accountant - Mainstay
Views in the last 30 days - 5
The job posting is seeking a Senior Accountant to join the Business Operations team The role involves owning Payroll Benefits administration performi...
View Details