Associate Director, Pharmacovigilence New Somerville, Massachusetts, United States, US Remote

bluebird bio; Somerville (MA); Remote; USD 100,000 - 150,000; Full time

Job summary

Join the Pharmacovigilance team at a leading gene therapy company, bluebird bio. As a PV expert, you'll oversee safety monitoring of clinical trials, ensure compliance with regulations, and contribute to safety reports. This role offers an opportunity to impact patient care through innovative therapies in a collaborative environment.

Qualifications

• Minimum 8 years of pharmaceutical industry experience, including 5 years in PV.
• Knowledge of global safety regulations and MedDRA terminology.
• Ability to work effectively in a collaborative team environment.

Responsibilities

• Oversight of safety monitoring activities and operations of clinical trials.
• Provide PV expertise on cross-functional teams.
• Participate in writing of aggregate safety reports.

Skills

Communication

Problem Solving

Organizational Skills

Education

Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree

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.

Apply for this job

*

indicates a required field

First Name *

Last Name *

Preferred First Name

Email *

Phone *

Location (City) *

Resume/CV *

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Education

School Select...

Degree Select...

Select...

Select...

Start date year

End date month Select...

End date year

LinkedIn Profile

Website

Will you now or in the future require bluebird bio to commence (“sponsor”) an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)? * Select...

Point of Data Transfer - GDPR * Select...

Your privacy is important to us. bluebird bio, Inc. will use the information provided on this form to evaluate you for the position you are applying for and stay in contact with you for recruiting and hiring purposes. Please take a moment to read the Data Privacy Consent located here and provide consent to the collection, processing, and notification of your rights regarding your personal information below. For more general information on how we will use, store, and protect the personal information provided through this form and on the website, please read our privacy policy locatedhere .

Read the Data Privacy Consent and select "I accept" to agree to the collection and processing of your personal information.