Job Abstract

Pharmacovigilance Specialist 

Kelly® Science & Clinical is seeking a Pharmacovigilance Specialist 
 for our top clients in Bridgewater, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts. 

Schedule: Hybrid 2 non consecutive days on site at the client 
Monday through Friday standard business hours
Pay rate $43-45 an hour
Length of assignment: Until Feb 2025
Responsible for post marketing and clinical safety activities, ensuring that Adverse Events are identified and processed in accordance with international regulations. Work in close collaboration with Company’s vendors and affiliates to ensure that individual case reports for pre- and post-marketed products are properly produced, exchanged, and submitted. The Pharmacovigilance Specialist will be responsible for the medical assessment of adverse events cases; performance and maintenance of adverse event case review. 
Responsibilities:
•    Involved in signal detection activities and notifying Risk management per guidance
•    Support the team for any PV audit or inspection.
•    Provide coordination and support for the internal PV activities for local PV activities. 
•    Provide support in establishing/maintaining PV system.
•    Responsible for ensuring compliance with applicable Regulations and Corporate policies local and global . 
•    Provides oversight and support for external safety data processing provider ensuring high quality and compliant case processing.
•    Review and approve adverse event reports for pre- and post-marketed product: clarify medical issues, ensure clear narratives, revise MedDRA terms and coordinate with external vendor and internal medical personnel as needed. 
•    Support the team preparation for any PV audit or inspection.
•    Ensure compliance with regulations, all SOPs and partner agreements.
•    Review of Clinical trial protocols Phase I Phase III to ensure consistent and proper recording and processing of trial related AEs and SAEs.
•    Assist with creation of Analysis of Similar events and Investigator notification letters for IND Safety reports generated from company sponsored clinical trials. 
•    Analyze metrics for critical Drug Safety processes to ensure compliance with SOPs and regulatory requirements. Formulate and implement improvements as needed. 
•    Represent the Pharmacovigilance department in interactions with key internal departments including Regulatory affairs, clinical R D, Medical and Quality Assurance and Medical communications. Review IND Annual and Periodic ADE reports; identify potential safety trends or signals; ensure accuracy and timely submission.
•    Inform manager and GPRM of safety related issues and potential trends and or signals arising from review of pre- and post-marketed safety data; recommend changes to labelling and Clinical Trial Investigator Brochure as needed.
•    Participate in review of SDEA and PV agreements with business partners, ensuring that company standards are upheld and international safety regulations are met.
•    Interact with compliance team to ensure necessary corrective and preventive actions have been taken to ensure compliance of pre- and post-marketing case processing.
•    Participate in creation and implementation of PV SOPs as needed. Maintain the internal and external correspondence within the defined duties and activities and ensures relevant archiving of PV documentation if needed. 
•    Oversight of Local PV vendor and US PV Support labeling update activities, maintenance of Reference Safety Information 
Requirements: 
•    Two to five years of Pharmacovigilance experience
•    Clinical safety and Pharmacovigilance regulations and guidelines. 
•    Use of safety database, preferably ARISg.
•    Understanding of local and International Pharmacovigilance regulations including GVP, GMP and ISO requirements
•    Excellent oral and written communication skills; excellent interpersonal skills and willingness to work in a team environment.
•    Demonstrates consistent attention to detail; highly organized and demonstrates understanding of workflow prioritization.

•    Education: 
•    BS or MS degree in Nursing, Pharmacy or related discipline or comparable field
What happens next?
Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what’s next in your career is what we’re all about,
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