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PAREXEL International Corporation

Drug Safety Specialist

PAREXEL International Corporation - Billerica, MA

Job Title

Drug Safety Specialist

Job Family

Medical Affairs

Auto req ID

40351BR

Location

USA - Massachusetts - Billerica

Why Work at PAREXEL

There are pivotal moments in every career:

Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That’s PAREXEL. We’re a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn

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, Twitter

, and Glassdoor

Job Description

The Drug Safety Specialist will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).Develop project specific safety procedures, workflows and templates

Perform project specific safety database setup, develop data entry guidelines, and perform user acceptance testing

Organization and coordination of study specific workflows with regard to processing and reporting of

Serious Adverse Events (SAEs)

Triage incoming reports for completeness, legibility and validity

Electronic documentation and quality control of drug safety information

Data entry of case reports into safety database / tracking system

Assessment of case reports for seriousness, causality and expectedness and the resulting reporting requirement

Request follow-up and perform query management

Coding of data in the safety database

Writing case narratives

Case reconciliation- coordinating activities with Data Management personnel

Line listing and tabulation generation for safety reports i.e. periodic safety reports, ad hoc safety reports, etc.

Qualifications

Sound knowledge of drug safety and the drug development process

 Knowledge of and ability to interpret and apply global safety regulations

 Experience in data analysis and evaluation of safety data

 Good presentation skills

 Analytical and problem solving skills

 Clear understanding of the regulatory submission process

 Proficient in database/literature searches

 Excellent interpersonal skills

 Excellent verbal / written communication skills

 Excellent organizational and prioritization skills

 Ability to work collaboratively and effectively in a team environment

 Client focused approach to work

 Experience with computer applications including database management and pharmacovigilance systems

Knowledge and Experience:

 Drug safety knowledge and experience

Education:

 Degree in Pharmacy, Nursing, Life Science, or other health-related field , or equivalent qualification/work experience

 Associates/diploma degree in any of the above with appropriate work experience

EEO Disclaimer

PAREXEL is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

9 days 7 hours ago

PAREXEL International Corporation

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Drug Safety Specialist PAREXEL International Corporation - Billerica, MA, United States

   

Location: Billerica, MA

Company Profile:
With every clinical trial you work on at PAREXEL, you'll be exposed to the future of medicine—contributing to significant life-saving advances and new treatments that are changing lives. So if you are inspired to make a difference in the world, we can help you make it possible.