Pharmacovigilance Scientist

Integrated Resources Inc.; Horsham (PA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company seeks a Scientist to conduct aggregate safety analyses and report writing, overseeing safety deliverables in a fast-paced environment. The role involves database searching, writing PBRERs/PSURs, and managing safety projects, requiring strong communication and relevant educational background.

Qualifications

• Minimum 3 years industry experience required for Bachelor's degree holders.
• Clinical/medical writing and/or pharmacovigilance experience preferred.
• Strong English communication skills are essential.

Responsibilities

• Ensure timely, quality deliverables for assigned tasks.
• Conduct searches of internal and external databases.
• Author and prepare core safety deliverables.

Skills

Aggregate safety analysis

Report writing

Project management

Communication

Education

Bachelor’s degree in health or biomedical science

Advanced degree in health or biomedical science

Tools

Microsoft Word

Excel

SAS JMP

Job description

At Mindlance, we strive to deliver value through the combination of right people, processes, technologies and program management solutions. Our methods include- applying domain expertise in specific industry segments, utilizing a highly-skilled workforce, leveraging a proven global delivery model, implementing structured and scalable quality processes and methodologies and yet, staying cost-effective

All in all, our expertise lies in providing trained and committed minds to help meet your business objectives, irrespective of the stage your business is in.
- See more at: http://www.mindlance.com/company/about.php#sthash.PmFrxcOo.dpuf

Job Description

Summary:
The Scientist role is primarily responsible for aggregate safety analyses and aggregate report writing. He/she will contribute or will be responsible for report writing and/or report ownership related to core safety deliverables including scheduled and ad hoc post-marketing aggregate reports.
Daily activities involve database searching, aggregate safety analysis and case level review, writing, planning, conducting meetings, and project management/coordination of strategic safety documents. The Scientist will partner with team members, stakeholders such as safety physicians, and a vendor. The Scientist must be able to work on multiple projects simultaneously and prioritize tasks.
Responsibilities Scientist would be responsible to contribute to or serve as report owner for scheduled and non-scheduled post-marketing safety reports and other deliverables as applicable. Scheduled reports include PBRERs/PSURs, PADERs, Addendums to Clinical Overview, and PBRER/PSUR Addendum Reports. Non-scheduled reports include Ad hoc reports in response to health authority queries or internal requests, health hazard evaluations, and labelling support documents.

Job Description:
• Ensure timely, quality deliverables for assigned tasks related to core deliverables with oversight as appropriate
• Initiate/conduct searches of internal and external databases
• Perform aggregate safety analysis and case level review Present results at Safety Management Team meetings as needed
• Author/contribute to the preparation of core safety deliverables
• Partner with vendor to develop reports/deliverables
• Comply with processes and ensure appropriate documentation
• Utilize technical skills and programs to analyze and organize data (eg, Excel pivot tables, SAS JMP)
• Adhere to report timelines and escalate issues to management as appropriate

Qualifications

Educational Qualification/ Experience Required:
• Bachelor’s degree in health or biomedical science (3+ years industry experience or equivalent) or
• Advanced degree preferred in health or biomedical science (2+ years industry experience or equivalent)
• Clinical/medical writing and/or PV experience
• Strong English verbal and written communication skills
• Aggregate safety report writing and aggregate safety analysis
• Project management of safety/regulatory documents
• Awareness of applicable regulations and guidances related to post-marketing aggregate safety requirements
• Experience using Microsoft word templates

Additional Information

Regards
___________________________________________________________________________________________________
Pooja Mishra | Team Recruitment | Mindlance, Inc. | Office: 732-243-0715 |