Director, Drug Safety & Pharmacovigilance Scientist

BioSpace; Waltham (MA); On-site; USD 150,000 - 200,000; Full time

Job summary

A leading pharmaceutical company in Waltham, MA is seeking a Director, Drug Safety & Pharmacovigilance Scientist to join their dynamic team. The role involves ensuring the safety of products, compliance with regulations, and leading collaborative efforts across departments. Candidates must possess extensive experience in pharmacovigilance and a commitment to patient safety.

Qualifications

• Minimum of 10 years in pharmacovigilance with at least 2 in leadership.
• In-depth understanding of global pharmacovigilance regulations.
• Strong analytical skills and proficiency with safety databases.

Responsibilities

• Monitor safety of pharmaceutical products and ensure regulatory compliance.
• Perform signal detection and risk management through data analysis.
• Collaborate with cross-functional teams on safety issues.

Skills

Leadership

Analytical Skills

Communication

Education

Advanced degree in life sciences (MD, PharmD, PhD)

Job description

Director, Drug Safety & Pharmacovigilance Scientist

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Company Overview

Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

Company Overview

Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

Role Summary

We are looking for an experienced and highly skilled Director, Pharmacovigilance Scientist to join our dynamic team. This person will be responsible for monitoring the safety of our pharmaceutical products, ensuring compliance with regulatory requirements, and contributing to the overall risk management strategy. The ideal candidate will have extensive knowledge of pharmacovigilance processes, strong leadership abilities, ability to work collaboratively with multidisciplinary teams, and a commitment to patient safety.

This role is based in Waltham, MA without the possibility of being a fully remote role.

Primary Responsibilities Include

• Signal Detection and Risk Management: Identify and evaluate safety signals through comprehensive data analysis. Author safety signal assessment reports and aggregate safety reports
• Write and maintain relevant SOPs and procedures in compliance with global safety regulations and guidelines, and provide training within Dyne Drug Safety and Pharmacovigilance and cross-functionally
• Regulatory Compliance: Prepare and coordinate submission of safety reports (PSURs, DSURs, CIOMS, etc.) to regulatory authorities, ensuring compliance with all local and international regulations
• Collaboration: Work closely with cross-functional teams, including clinical operations, regulatory affairs, and medical affairs, to address safety issues and develop effective risk minimization strategies
• Documentation: Maintain accurate and thorough documentation of safety data and related activities in compliance with Good Pharmacovigilance Practices (GVP)
• Training and Development: Provide training and support to internal teams on pharmacovigilance processes, regulations, and best practices.
  
  
  

Education And Skills Requirements

• Advanced degree in life sciences (MD, PharmD, PhD, or equivalent) is required.
• Minimum of 10 years of experience in pharmacovigilance, with at least 2 year in a leadership role
• In-depth understanding of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH, etc.)
• Strong analytical and problem-solving skills; proficiency with safety databases and data analysis tools
• Exceptional written and verbal communication abilities, with a proven track record of effectively presenting complex information to diverse audiences
• Demonstrated ability to manage multiple projects and deadlines in a fast-paced environment
• Proven experience in leading teams and fostering a collaborative work environment.
  
  
  

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Internet News

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