Associate Director, Pharmacovigilence

bluebird bio; Somerville (MA); Remote; USD 120,000 - 150,000; Full time

Job summary

Join a leading biotechnology company as a Pharmacovigilance Expert. This role focuses on ensuring safety monitoring of clinical trials and regulatory submissions, contributing to the success of innovative gene therapies. Ideal candidates will have significant pharmaceutical industry experience and a strong ability to collaborate effectively in a fast-paced environment.

Qualifications

• Minimum 8 years in pharmaceutical industry; 5 years directly in Pharmacovigilance.
• Experience in preparing safety reports and knowledge of global safety regulations.
• Thorough understanding of drug development processes.

Responsibilities

• Oversee safety monitoring activities for clinical trials.
• Provide PV expertise on cross-functional teams.
• Prepare aggregate safety reports like DSURs and PSURs.

Skills

Communication

Teamwork

Problem Solving

Education

Degree in Pharmacy, Nursing, Epidemiology or Biosciences

Job description

Somerville, Massachusetts, United States, US Remote

About bluebird bio

At bluebird every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more bluebird days. We are doers, thinkers and collaborators who embrace and live by our values:

• Persist for Purpose
• Stay humble and curious
• Keep it real
• Celebrate (sm)all wins

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

ABOUT US

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. Working in our growing Pharmacovigilance team, as an individual contributor PV expert you will provide strategic and operational PV support for bluebird’s developmental products in close collaboration with senior PV and Medical staff.

RESPONSIBILITIES

• Oversight of day to day safety monitoring activities and safety operations of clinical trials for the assigned product
• Provide PV subject matter expertise on Program Teams and other cross-functional platforms throughout the company
• Facilitate cross-functional Safety Review Committee meetings; includes coordinating materials, data presentation and all outputs, and agenda
• Review and provide PV input for development of protocols, IBs, CSRs and other relevant study documents
• Participate in writing of aggregate safety reports, e.g., DSURs, PSURs
• Provide subject matter expertise and input for regulatory submissions, e.g., NDA, MAA and regulatory responses, collaborating with cross-functional areas as appropriate

QUALIFICATIONS

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV
• Minimum8 years of pharmaceutical industry experience, including a minimum of 5 years of working directly in PV
• Knowledge of global safety regulations, MedDRA terminology and its application, and principles of data entry and data extraction with global safety databases
• Experience reviewing cumulative safety data with ability to interpret, synthesize, communicate, and present complex clinical /pharmaceutical information
• Experience in the preparation and authoring of pre- and post- aggregate safety reports
• Thorough understanding of the drug development process and context applicable to safety surveillance activities
• Ability to execute and follow-through to completion
• Ability to work 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 good problem solving ability
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
• Excellent communication skills and ability to influence across multiple functions.
• Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

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