Sr Pharmacovigilance Principal Scientist

ProClinical are currently recruiting on behalf of a leading global pharmaceutical company that specialises in multiple therapy areas. The organization is seeking for a Senior Pharmacovigilance Principal Scientist position to join their team in Massachusetts.

The Pharmacovigilance Scientist will provide pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products. They will also be Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed products.

Job Responsibilities:

• Reviewing Overseeing report QCs, reviews, follow-ups, and reportability assessments, before inputting them into aggregate safety reports.
• Liaising 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.
• Representing the pharmacovigilance department in cross-functional teams, committees, and external environments at a global and regional level as required.
• Acting as the company's lead responder and source of expertise for safety related issues for designated compound.
• Closely interacting with senior PV physicians and the safety Therapeutic Area Lead (TAL), particularly when the responsible GSL.
• Supporting and overseeing of pharmacovigilance operational activities for designated compounds, with lead responsibilities when acting as the GSL
• Mentoring and guiding less experienced colleagues within the department.
• Conducting project activities for designated developmental products:
• Leading the setting up of safety procedures for complex developmental programs
• Contributing to development of safety exchange agreements for co-development projects
• Reviewing and providing functional area expertise for development of protocols, IBs, SAPs, CSRs, and other relevant project/study documents.
• Close knowledge of protocols to effectively respond to safety issues.
• Providing investigator and monitor training on safety procedures.
• Participating in Global Safety Teams, coordinating all aspects of signal detection/safety review activities.
• Drafting responses to regulatory/ethics safety questions.
• Assisting with writing and maintenance of the Safety Monitoring Plan.
• Assisting with the set-up and running of DSMBs.
• Closely working with physicians, both technically and managerially.
• Performing ad hoc analyses e.g. in response to regulatory queries
• Responding to different audiences in a clear and concise manner.
• Leading presentations to Safety Board, with the detailed preparatory work this implies and, where ad hoc issues arise, the short timelines that can ensue.

Skills and Requirements:

• At least a Bachelor's degree, though an advanced degree or a specific pharmacovigilance qualification is preferred (MD, PhD, and PharmD).
• Between 9-20 years of experience, depending on qualification, in a healthcare, clinical, or pharmacovigilance-related environment. (9 with a Ph.D., 15 with a Master's, 20 with a Bachelor's).
• Excellent databases and coding skills including ability to perform advanced searches
• An in-depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety profile and risk/benefit analysis.
• Global player in a global PV organization.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Kevin Cassini at +1 215 531 5288 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-KC1