Kelly Services Pharmacovigilance Specialist II: Marlborough, MA in Marlborough, Massachusetts

Pharmacovigilance Specialist II: Marlborough, MA

Kelly Clinical Resources is seeking a Pharmacovigilance Specialist II to work for one of our customers in Marlborough, MA. This is a yearlong contract assignment.

As a Pharmacovigilance Specialist II placed with Kelly Clinical Resources you will be responsible for processing of adverse event information from all sources including clinical trials, post-marketing and published literature.

Responsibilities:

Processing of adverse event information from all sources including clinical trials, post-marketing and published literature. Preparation of aggregate reports including PSURs, ASRs, DSURs and US Periodic Reports. Serve as pharmacovigilance resource to Clinical Development Teams. Collect and process incoming adverse event reports from all sources Perform initial assessment of seriousness, expectedness, causality, and reportability Complete and QC data entry of incoming reports Identify missing or discrepant information and perform active follow-up Prepare expedited reports for submission to regulatory authorities and ethics committees Serve as pharmacovigilance resource to Clinical Development Teams Collaborate with clinical development staff on technical and scientific issues regarding SAE and SUSAR reporting Work closely with safety physicians

Requirements:

Prefer a Nurse (RN), Pharmacist (RPh or PharmD) or Physician’s Assistant or a person with BS (Life Sciences Background) and minimum of 2 years of pharmacovigilance case processing experience including both clinical trial and post-marketing experience. Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines Working knowledge of MedDRA coding Understanding of pharmacovigilance -related information systems Experience with the preparation and submission of regulatory reports Experience working in electronic document management systems

Why Kelly?

As a Kelly Services employee, you will have access to numerous perks, including:

Exposure to a variety of career opportunities as a result of our expansive network of client companies Career guides, information and tools to help you successfully position yourself throughout every stage of your career Access to more than 3,000 online training courses through our Kelly Learning Center Weekly pay and service bonus plans Group- rate insurance options available immediately upon hire*

Apply today!

Why Kelly®? With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.]]

Category: Biotech/Clinical/R&D/Science