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.