Sr. Principal Pharmacovigilance Scientist

Job Summary

Senior Principal Pharmacovigilance Scientist

Pay Rate: $90/hr. Max w2 only

9 Month Contract | Remote

Step into a high-impact role within a global R&D organization advancing transformative therapies across four key therapeutic areas. This position leads critical pharmacovigilance activities for both developmental and marketed products, serving as a strategic and authoritative voice on Global Clinical Development Teams.

You'll drive signal detection and safety monitoring, oversee key operational PV deliverables, and collaborate closely with global medical safety leadership. As part of the GPSE Global Medical Safety team, this role partners cross-functionally to shape safety strategy and ensure robust oversight throughout the product lifecycle.

location: Telecommute

job type: Contract

salary: $80 - 90 per hour

work hours: 9 to 5

education: Bachelors

Responsibilities

• Technically competent to perform all usual Principal Pharmacovigilance Scientist/Senior Pharmacovigilance Scientist workload, including case report QC, review, follow-up, and reportability assessments, and input into aggregate safety reports.
• 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 the 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.
• In-depth knowledge and understanding of designated products/studies.
• Expect close interaction and involvement with senior PV physicians.
• Provide support and oversight of pharmacovigilance operational activities for designated compounds.
• Conduct project activities for designated developmental products.
• Lead set up of safety procedures for complex developmental programs.
• Contribute to the development of safety exchange agreements for co-development projects.
• Review and provide functional area expertise for the development of protocols, IBs, SAPs, CSRs, and other relevant project/study documents.
• Close knowledge of protocols to effectively respond to safety issues.
• Participate in Global Safety Teams, coordinating all aspects of signal detection/safety review activities.
• Draft responses to regulatory/ethics safety questions.
• Close working relationship with physicians, both technically and managerially.
• Perform ad hoc analyses e.g. in response to regulatory queries.
• Integral to Global Safety Teams and associated support.
• Other functions as directed by departmental and business needs.
• Proficient in all communication skills, with the agility to respond to different audiences in a clear and concise manner. Where acting as the GSL can expect to lead presentations to Safety Board, with the detailed preparatory work this implies and, where ad hoc issues arise, the short timelines that can ensue.

Qualifications

• Bachelor's degree required. Advanced degree or specific pharmacovigilance qualification preferred (MD, Ph.D., and PharmD).
• 6+ years of related experience required and must include:
• Conducting safety signal detection, assessment, and management from various sources including medical scientific literature and global safety database
• Performing the medical assessment of the individual case and aggregate safety reports for product safety profile and addressing safety related regulatory authority requests
• Apply clinical trial methodology, various regulatory submissions, pharmacovigilance regulations, and safety profile to perform risk/benefit analysis (risk management plan)
• Utilize proficient communication skills with the ability to review, analyze, interpret and present complex safety data to a high standard during internal and global cross-functional collaborations for patient safety.
• Excellent databases skills and detailed understanding of MedDRA codes including the 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.
• Advanced computer skills with the ability to work within multiple systems; advanced skills in Microsoft Office products (including Outlook, Word, and Excel)
• Global player in a global PV organization.

skills: Pharmacovigilance, MedDRA Coding, Signal Detection, Individual Case Safety Report (ICSR), Regulatory Submission Compliance, Safety Data Analysis

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

u50000030026