13 days old

Pharmacovigilance Specialist

Kelly Services
Cambridge, MA 02238
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Pharmacovigilance Specialist** at a prestigious Fortune 500 company working in **Cambridge, MA.**

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( ) however your resume must be received via the Submit Resume button included within.

**Job Title: Pharmacovigilance Specialist**

**Pay: Up to $52 per hour**



1). Drug Safety Experience

2). Pharmacovigilance

3). Ideally a Health Care Professional/Nurse background in Adverse Events/Effects

4). Argus safety database experience


Primary responsibility is oversight of processing of adverse events and safety data to ensure compliance with worldwide regulatory requirements, as well as adherence to internal procedures and contractual requirements with business partners.

Monitor vendor timeliness and quality to ensure compliance to company and global regulatory reporting requirements. Support and monitor the vendors day-to-day activities and urgently address and/or escalate any issues.

Liaise with vendor and QC of ad hoc vendor tasks.

Oversee other activities performed by the vendor such as literature review, reconciliation, etc.

Assist with SOP writing and special projects related to case processing activities.

The Candidate must be able to demonstrate solid knowledge of Pharmacovigilance regulations and ICH guidelines, strong attention to detail and the ability to meet deadlines.

Experience with AE case processing and MedDRA coding.

Vendor oversight experience required.

Must have solid knowledge of global safety Pharmacovigilance regulations and ICH guidelines, strong attention to detail and the ability to meet deadlines.

Excellent written and oral communication skills are a must. Proficiency with Microsoft office suite (eg: Word, Excel, PowerPoint) as well as Outlook and SharePoint.

Prior experience with Argus

Excellent clinical and post-marketing adverse event assessment review/documentation skills

Excellent interpersonal, communication, analytical and organizational skills

Experience working with vendors/partners relationship experience and mentorship of internal and/or vendor staff

Strong knowledge of global clinical safety and pharmacovigilance regulations

Strong knowledge of MedDRA terminology and coding practices

Adept with safety databases including report generation and ad hoc querying

Experience with late case investigation/CAPA

Strong attention to detail

Demonstrated ability to work in a fast-paced environment and simultaneously manage multiple competing tasks and demands

At least 3-5 years of drug safety experience in a pharmaceutical company with the following demonstrable skills:

o Post-market and Clinical Trial case processing activities, including data entry, narrative writing, and assessment of report-ability

o MedDRA and WhoDrug Dictionary coding expertise

Demonstrated ability to work independently, take initiative and complete tasks to deadlines

**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** at **.**

**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**

**Kelly Services is an Equal Opportunity Employer**

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 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 careerconnect with us today.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at
Posted: 2019-11-08 Expires: 2019-12-09

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Pharmacovigilance Specialist

Kelly Services
Cambridge, MA 02238

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