Role Overview
The safety of all medicines is monitored throughout their use in healthcare practice. Primarily, the 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 follow-up actions for processed ICSR
- Knowledge of safety concepts, per ICH and FDA guidelines per device safety reporting requirements
- End-to-end case processing for ICSRs from company sponsored trials including generating and raising queries to investigator sites.
- 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 of scientific literature for the identification of reportable cases
- Contribute to the development and implementation of pharmacovigilance processes, procedures, and training programs
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) Working knowledge of MedDRA and WHODrug. Knowledge of clinical trial activities is preferred, and 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: Experience within a pharmaceutical, CRO, or healthcare environment preferred (2 years)
• 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 role operates remotely in a professional environment and routinely utilizes standard office equipment such as computers, phones, and printers, etc. interaction with internal and external contacts independently.
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. according to company policy.
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.
