25 days old

Sr Pharmacovigilance Scientist

Kelly Services
Cambridge, MA 02238
**Kelly Services** is currently seeking a Sr Pharmacovigilance Scientist in **Cambridge, Ma** to work a contract assignment 6 **month duration** for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.

**Primary Responsibilities includes:**


Provides pharmacovigilance functional area expertise and support to project teams for assigned developmental product(s). As appropriate, may lead safety support for a compound as a back up to the Global Safety Lead (GSL).

Liaise with Pharmacovigilance Operations Lead for operational activities for assigned developmental product(s).

Represents pharmacovigilance, both regionally and globally. Closely involved in signal detection/safety monitoring activities.

Provides functional & therapeutic area expertise, supporting less experienced colleagues.


Technically fully competent to perform all usual Senior Principal Pharmacovigilance Scientist workload, including case report QC, review, follow-up and reportability assessments and input into aggregate safety reports, with the flexibility of mindset this requires.

Liaise with other relevant functional areas both within and outside of global PV to best ensure the most efficient and timely attainment of compliant and patient focused safety data.

Represent pharmacovigilance department in cross-functional teams or committees and external environments at a global and regional level as required, with the advanced communication skills this requires.

Demonstrates in-depth knowledge and understanding of designated products/studies. Provides support and oversight of pharmacovigilance operational activities for designated compounds.

Provides mentorship and guidance for less experienced colleagues within the department.

Conducts project activities for designated developmental products and leads set up of safety procedures for complex developmental programs:

o Reviews and provides functional area expertise for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents;

o Demonstrates close knowledge of protocols to effectively respond to safety issues;

o Participates in Global Safety Teams, coordinating all aspects of signal detection/safety review activities;

o Drafts responses to regulatory/ethics safety questions;

o Performs ad hoc analyses, e.g. in response to regulatory queries;

o Are integral to Global Safety Teams and associated support.

Proficient in all communication skills, with the agility to respond to different audiences in a clear and concise manner.

Education, Behavioral Competencies and Skills:

Bachelors degree required. Advanced degree or specific pharmacovigilance qualification preferred (MD, PhD, and PharmD);

Bachelors with minimum 10 years of experience in healthcare, clinical or pharmacovigilance related environment;

Masters with minimum 6 years of experience in healthcare, clinical or pharmacovigilance related environment;

PhD with minimum 4 years of experience in healthcare, clinical or pharmacovigilance related environment;

Excellent databases and coding skills including ability to perform advanced searches;

In depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety profile and risk/benefit analysis;

Critical thinking and decision making skills;

Ability to review, analyze, interpret and present complex data to a high standard;

Global player in a global PV organization;

Excellent communication and presentational skills;

Good level of computer literacy;

Excellent organization skills and ability to prioritize;

Excellent attention to detail.


**For immediate consideration, please send your resume in a WORD document to**

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

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**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.



Posted: 2020-08-26 Expires: 2020-09-26

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Sr Pharmacovigilance Scientist

Kelly Services
Cambridge, MA 02238

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