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Consultant, safety physician pharmacovigilance, pharmaceuticals

GForce Life Sciences

This is a Full-time position in Trenton, NJ posted December 2, 2019.

Summary: Our client, a Global Pharmaceutical firm in New Jersey has engaged GForce Life Sciences to identify a Pharmacovigilance Physician.

This person will support safety teams in all aspects of pharmacovigilance and risk management activities for assigned products, both marketed and in development.

Key activities include medical analysis and decision making for the development and maintenance of the Company Core Safety Information, ad hoc aggregate safety reports, periodic safety update reports (PSURs), signal detection activities and reports risk management plan (RMPs/REMS) and individual case safety reports.

He/she will work in cross-functional teams with counterparts in regulatory, clinical development, pre clinical, manufacturing/quality, global pharmacovigilance and other functional areas to identify, evaluate and communicate safety issues relevant to his/her assigned products.

Duties / Expectations: Analysis of comprehensive product information, synthesis, risk-benefit assessment and reporting Proactive Monitoring of product safety profile from FIH throughout lifecycle Primary ownership and accountability for product signaling review, analysis, delivery and approval Timely action and communication of finding safety governance forums Leadership and ownership of internal safety governance bodies (SMT, JSMT).

Active contribution to internal and external forums (e.g., DMC, Advisory Boards) Contribution and review of safety documents from individual patient data to to submission-level safety documents Partnership with GCD Project Leaders on Program Development from Phase I to LCM regarding safety and risk benefit topics and decisions Contribute to label development, scientific regulatory responses.

Review and Approve Coding.

Active, Regular Utilization of Data Review, Reporting and Visualization Tools & Systems.

Provide medical and PV oversight and key input to: Protocols Investigator brochures Safety summaries Clinical study reports Regulatory reports (periodic, ad hoc) Labeling changes Mandatory Requirements:Requires a strong medical background evidenced by clinical training Solid knowledge of FDA and global PV regulations.

Knowledge of clinical trials, good clinical practices, and ICH guidelines.

Oncology or Neurology experience a plus Experience in working in a global setting Experience with industry software and databases.

Sound computer skills and be well versed in the use of Microsoft Office Education & Related Experience: MD degree with US medical license (preferred) Demonstrated experience (at least 2-5 years) as a Safety/PV professional in a pharmaceutical industry Experience with both development and product launch/post marketed products preferred.

Ability to act as in-house authority/leader in Safety and Pharmacovigilance; and be fully accountable for Safety of assigned products.

Experience interacting with global regulatory authorities.

Term & Start:Start ASAP 12 + month contract Must be in Northeastern New Jersey or willing to relocate.