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Upstream Bio · 1 week ago

Pharmacovigilance Scientist - Director / Sr. Director

Waltham, MA

Full-time

Onsite

Director/Executive

$216K/yr - $263K/yr

10+ years exp

Upstream Bio is a clinical-stage biotechnology company focused on developing treatments for inflammatory diseases. They are seeking an experienced Pharmacovigilance Scientist to provide operational, strategic, and analytical support for the pharmacovigilance department, including oversight of safety monitoring activities and development of internal processes.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Responsibilities

Job is a mix of operational support/oversight as well as PV analytics

Oversight of day-to-day safety monitoring activities and safety operations of clinical trials for the assigned product(s) including SAE/AESI review and processing, SUSAR reporting, and data reviews

Facilitate internal cross-functional Safety Management Committee meetings for routine signaling and ad hoc urgent safety issues; includes coordinating materials, data presentation and all outputs, and agenda

Review and provide PV input for development and updates of protocols, IBs, ICFs, CSRs and other relevant study documents

Project lead and author for annual DSUR

Oversight of vendor, specific to PV deliverables and metrics

Provide strategic direction for the PV department on initiatives such as functional service provider model and global safety database strategy

Coordinates with Quality on CAPAs, quality events, and process improvements

Responsible for the development of supportive internal processes and SOPs

Provide PV subject matter expertise to cross-functional platforms throughout the company

Qualification

Pharmaceutical industry experiencePharmacovigilance expertiseMedDRA terminology knowledgeSafety data analysisDrug development processCollaborative team environmentCommunication skillsProblem-solving abilityOrganizational skills

Required

Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV

Minimum 10/12 years' pharmaceutical industry experience, including a minimum of 8 years' experience in PV

Knowledge of MedDRA terminology and its application

Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data

Experience in the preparation and authoring of pre- and post- aggregate safety reports

Thorough understanding of the drug development process and context applicable to safety surveillance activities

Ability to execute and follow-through to completion and documentation

Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

Independently motivated, detail oriented and good problem-solving ability

Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities

Excellent communication skills and ability to influence across multiple functions