Pharmacovigilance Scientist job Bedminster New Jersey
Pharmacovigilance Scientist job Bedminster New Jersey
My Spider Scam Awareness Contacting Us F. A. Q.
 
Job Seekers
Search Jobs
Browse Jobs
Post a Resume
Job Alerts
 
Employers
Search Resumes
Browse Resumes
Post a Job

Pharmacovigilance Scientist Job



Employer Name: SpiderID: 8274764
Location: Bedminster, New Jersey Date Posted: 12/19/2018
Wage: Negotiable Category: Medical/Health
Job Code: JR000008872

Job Description:

  • The Pharmacovigilance (PV) Scientist serves as a product lead for PV activities within the Global Pharmaceutical (GPV), Aggregate Safety Reporting function. The PV Scientist team is responsible for overseeing and leading the process for safety signal management activities, aggregate reports responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities.


Principal Responsibilities


The PV Scientist serves as a product lead for PV activities within the GPV, Aggregate Safety Reporting function. The PV Scientist team is responsible for overseeing and leading the process for safety signal management activities, aggregate reports responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities. The Senior PV Scientist also serves as a Subject Matter Expert (SME) for GPV and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product-specific information.



Leads the signal management process (e.g., signal tracking, leading review meetings, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Leads signaling review process and collaborates with the Global Safety Leads (GSL) product Safety Signaling Team meetings. Manages literature review for safety information.



Collaborates with GSL for assigned investigational programs including clinical trial activities (e.g., protocol review, ICF review) safety committee management, data analysis, signal detection, ad-hoc requests and other product activities, as assigned.



Leads process for responding to safety questions from regulatory authorities.



Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions



Leads and collaborates with Aggregate Reports on strategy, review, and finalization of aggregate safety reports for assigned products, such as DSURs, PBRER/PSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).


Minimum Requirements


Experience / Skills:


Education:


Bachelor's Degree in biologic or natural science; or health case discipline Advanced degree (e.g., PharmD, M.D.) preferred or extensive PV Experience.


Experience:



  • 5 years minimum of experience in the pharmaceutical/ biotechnology industry in a safety related role.

  • Ideally looking for a combination of experience including experience in aggregate safety reports and safety signal management. Strong background in clinical trial drug safety is required

  • Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).

  • Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues

  • Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests. Oversees and mentors less experienced PV Scientist staff.

  • Applies clinical judgment to interpret case information.

  • Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes knowledge of case processing, expedited reporting rules, and safety database concepts.

  • Strong organizational skills, including the ability to prioritize independently with minimal supervision.

  • Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems.


Organizational Relationship/Scope:



  • The PV Scientist reports directly to the Director, Aggregate Pharmacovigilance GSL and will operate independently under limited supervision and will participate in determining work objectives.

  • The Medical Director GSL will work closely with members of Global PV, Regulatory Affairs, Clinical Operations, Medical Information, Product Monitoring and Legal.




Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:


Contact Information:
Contact Name: Future Step Company Type:
Company: Future Step
City:
State:
Zip:

Send ad to a friend


    





© 2020 Job Spider
Privacy Policy | CC Marketing Sites | Site Map | Links