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18 days old

PV Scientist

Kelly Services
Summit, NJ 07901
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 Scientist** at a prestigious Fortune 500 company working in **Summit** **, NJ**


**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 ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.


**Job Title: Pharmacovigilance Scientist**


**Pay: $81 per hour**


**Job description:**


The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.


**Position Summary / Objective**

Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams. Appropriately perform core signal detection activities and elevate program or portfolio issues impacting key MST programs, priorities, resources, and milestones with appropriate oversight. Author responses for safety data queries and contribute to specified PV sections of the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR). Ensure pharmacovigilance regulatory compliance with oversight, as needed.


**Position Responsibilities**

Lead Safety Data Review (SDR) Teams and participate in related PV and product-development subteam(s). Appropriately elevate signal detection findings impacting key MST activities, milestones, and documents to the MST Chair. Support individuals in aspects of project management, drug development and MST requirements, as appropriate to meet overall MST/subteam needs.

Author and contribute to specified PV sections of the PBRERs and DSURs with oversight, as needed

Author responses to safety data queries from health authorities including coordination and integration of scientific, medical, and regulatory input from a variety of scientific sources and functional groups, as needed to support responses to safety data/ad hoc queries and HA requests.

Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.

Collaborate within and across functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required.

Apply knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Share with individuals and teams on these applied learnings.


**Experience Requirements** :

Minimum of 8-10+ years BS/RN; 7 -10 years MS/PharmD/PhD/MD or equivalent relevant Pharmaceutical Industry experience


**Key Competency Requirements**

Strong understanding of medical concepts, drug development, pharmacovigilance, risk management and global regulatory safety and risk management health authority requirements and submission milestones.

Strong understanding of project planning methods; demonstrated ability to manage timelines and to prioritize; ability to align operational milestones and activities with operational representatives in other functional areas. Appropriately escalates issues that could impact activity timelines or quality.

Ability to effectively lead and work well within cross-functional teams, using strong organizational, facilitation, and interpersonal communication skills.

Strong understanding and communication of scientific subject matter, including authoring scientific documents (eg, pharmaceutical regulatory documentation and/or publications in peer-reviewed journals).

Attention to detail along with excellent scientific, analytical and conceptual skills. Demonstrated ability to understand, research, independently investigate, interpret, and reach reasoned conclusions regarding complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, postmarketing reports, scientific literature, and regulatory documents)

Demonstrated excellent knowledge and use of MS Office (or other equivalent office suite) programs such as Excel and PowerPoint; applying technical skills to analyze and summarize scientific-medical-safety data, and to portray and summarize scientific-medical-safety concepts and teach these capabilities to others.


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


**_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** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-06-04 Expires: 2021-07-05

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PV Scientist

Kelly Services
Summit, NJ 07901

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