Safety Lead

Precision Medicine Group; Peapack-Gladstone (NJ); On-site; USD 110,700 - 166,100; Full time

Benefits offered by this job

Annual discretionary bonus

Health insurance

Retirement savings

Paid time off

Job summary

Precision Medicine Group in the United States is seeking an experienced Safety professional to lead pharmacovigilance activities, oversee SAEs, and manage global safety reporting for multiple studies. You will interface with sponsors, vendors and internal teams to design safety collection tools, implement reporting plans, and drive CAPA, audits, and process improvements while mentoring Safety Specialists.

Strong regulatory knowledge (FDA, ICH) and excellent communication are essential for

Qualifications

• BA/BS degree required.
• 10+ years clinical safety experience.
• 5+ years Pharmacovigilance (PV) experience.
• Excellent communication and analytical skills.

Responsibilities

• Interfacing with sponsors, vendors, and internal team members in safety/PV.
• Participate in assessment and setup of a safety database to capture SAE data.
• QC of documents and safety reports.
• Prepare and/or review project-specific safety reporting plans and medical coding plans.
• Provide safety budgeting oversight and SOP development.
• Serve as subject matter expert for department.
• Provide training and mentorship for Safety Specialists.
• Participate in audits and investigator meetings.
• Support CAPA management and bid defenses.
• Resource management and oversight for safety projects.
• Lead safety initiatives and cross-functional development activities.
• Assist in regulatory responses related to safety/pharmacovigilance.

Job description

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

Minimum Required:

• BA/BS degree
• 10+ years clinical safety experience
• 5+ years Pharmacovigilance (PV) experience

Other Requirements

• Health care professional
• Hands on 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.

Preferred

• Nursing or pharmacy degree
• Industry experience in CRO or pharmaceutical company
• Project management experience

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range: $110,700 USD - $166,100 USD

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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.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [e-mail].