Drug Safety Lead (Remote)

Position Summary

Responsibilities will include but may not be limited to; project specific teleconferences/meetings (i.e.kick off meetings, internal study specific meetings, client governance meetings) Safety budget review and approval as needed, safety management plan development, oversight of serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel.

Essential functions of the job include but are not limited to:

Interfacing with sponsors, vendors, and other internal team members in the area of safety/PV to assist in the design and implementation of safety collection tools, processes, and reporting systems.

Participate in the assessment and set-up of a safety database to capture SAE data.

QC of documents and safety reports when needed

Preparation and/or review of project specific safety reporting plans and medical coding plans

Preparation and/or review of safety training materials

Review of Safety related budget tasks and activities

Develop and manage standard operating procedures and work instructions.

Serve as subject matter expert for department.

Provide ongoing training and mentorship for Safety Specialists

Participate in audits and audit preparation, kick-off meetings, and investigator meetings.

Participate in the CAPA management process

Participate in bid defenses for existing and potential clients.

Assist departmental management with resource management.

Assist departmental management with oversight.

Serve as project manager for safety standalone projects.

Lead departmental initiatives and cross-functional development activities.

Support the generation of SAE/AESI queries and tracking including oversight in the query resolution escalation efforts.

Provide input and review of responses to regulatory agency questions with regard to safety/ pharmacovigilance activities.

Assist clients and/or other departmental staff with safety-related reviews and other services.

Qualifications

Job qualifications:

BA/BS degree

5+ years Pharmacovigilance (PV) experience together with experience in a client facing role working as a lead

Candidates such have experience working for a Clinical Research Organisation together with experience working for a Pharmaceutical company is preferred

Experience with global safety database(s), SAE case processing, and safety reports generation

Working Knowledge Of MedDRA And WHODrug

Working knowledge of FDA safety regulations, ICH guidelines, and Global regulations

Demonstrated knowledge of relevant regulatory agency(s) guidelines governing both Safety reporting and processing for clinical trial environments.

Demonstrated knowledge of supporting internal audits, inspection readiness and regulatory agency(s) inspection support for clinical trials including BLA or NDA approval inspections.

Excellent communication and analytical skills (written and oral).

Excellent judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.

Ability to work in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease.

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

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