Job Description
Job Description Salary:
Role Overview
The safety of all medicines is monitored throughout their use in healthcare practice. Primarily, the Sr PV associate is involved in monitoring, processing, controlling, and reporting individual case safety reports and aggregate safety reports for company products. These activities are performed in accordance with FDA and global pharmacovigilance regulations for the detection, assessment, understanding and prevention of adverse effects or any other medicine related problems. This role will work closely with pharmacovigilance service providers, internal pharmacovigilance teams, and business partners to ensure accurate and timely pharmacovigilance information processing.
Primary Duties & Responsibilities
Review of individual case safety reports (ICSR) ensuring that adverse event reports are processed in a timely manner, in accordance with the appropriate company SOPs, study protocols, and within regulatory timelines
Determines ICSR follow-up actions
Knowledge of safety concepts, per ICH and FDA guidelines per device safety reporting requirements
Assist with data-lock reconciliations and ensure all cases are complete and all outstanding queries are resolved and closed
Provide pharmacovigilance input on essential study documentation from (study protocols, clinical trial agreement, safety management plan, clinical trial agreement, informed consent form, case report forms, protocol amendments and study reports)
Liaise with contracted partners, PMs, Clinical operations, IRBs, CRAs,
doctors/consultants
or investigators who participate in clinical trials.
Remain up to date on all appropriate current health authority regulations and guidance
Perform reconciliations with business partners, and other local US and global teams
Assisting with pharmacovigilance processes, supporting preparation of SOPs, compiling data for FDA aggregate report submission
Author or review FDA aggregate safety reports such as periodic adverse drug experience reports (PADERs) along with the cover letter
Research and draft responses to inquiries from patients, healthcare professionals, and internal stakeholders in the form of FAQs and Standard Response Letters.
Interact with other departments and as needed on pharmacovigilance matters
Maintain inspection readiness
Work closely with PV CRO
Review scientific literature for the identification of reportable cases
Additional Duties & Responsibilities
Prepare/review SOP, WI
ICSR processing for Clinical trial cases
Competencies/Career
level
Please list all that apply : Knowledge of FDA/EMA/ICH guidelines and the ability to interpret and apply applicable regulations. Prior experience working with pharmacovigilance databases (e.g. ARGUS, ArisG) and EDC clinical trial systems (e.g. Medidata Rave, ClinTrak, Veeva Vault). Working knowledge of MedDRA and WHODrug. Knowledge of clinical trial activities preferred. Microsoft Office
Requirements and Personal Skills
Education:
RPh, Pharm.D, RN or related degree in a scientific field
Languages:
English Required (not specific to employee)
Experience:
Pharmacovigilance experience within a pharmaceutical or CRO environment (2 plus years)
Travel:
Not Required
Personal skills:
In-depth knowledge of the Drug Development process, signal detection, and regulatory affairs
In-depth knowledge of domestic and global safety regulations.
Profound knowledge of scientific, medical, and clinical research terminology such as MedDRA coding.
Sound knowledge of Microsoft Office applications, Outlook Mail/Calendar.
Excellent written and oral communication and organizational skills.
Uncommon flexibility and ability to manage simultaneous priorities, changing Deadlines, and limited resources.
Actively engage in process enhancement by identifying inconsistencies, inefficiencies and offering a fresh perspective on those targeted issues
Physical Demands
This job operates in a remotely in a professional environment. This role routinely uses standard office equipment such as computers, phones, printers, etc. Is required to interact with internal and external contacts independently. Is regularly required to talk or hear either in person or over a dial tone phone, as well as a mobile phone, when applicable. Is often required to stand, walk, bend, lift, or sit. Is desk-based and may be sitting for long periods of time. Must regularly use fingers and hands for fine manipulation:
typing, writing, using hand-held device (iPad, laptop, cell phone, keyboard, printer). Must communicate clearly:
phone calls, emails, in-person conversations. Must possess ability to make sound decisions, process complex information, manage multiple tasks simultaneously, model behavior for other employees, and other cognitive
Position Type and Expected Hours of Work:
This is a full-time position. Days and hours of work are Monday through Friday, 9:00 a.m. to 5 p.m.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
The employee:
Is required to interact with internal and external contacts independently.
Is regularly required to talk or hear either in person or over a dial tone phone, as well as a mobile phone, when applicable.
Is often required to stand, walk, bend, lift, or sit.
Is required to occasionally lift office products and supplies, up to 40 lbs.
Is desk-based and may be sitting for long periods of time.
Must regularly use fingers and hands for fine manipulation: typing, writing, using hand-held device (iPad, laptop, cell phone, keyboard, printer)
Must communicate clearly: phone calls, emails, in-person conversations.
Must possess ability to make sound decisions, process complex information, manage multiple tasks simultaneously, model behavior for other employees, and other cognitive functions.
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