A pharmaceutical company in New Jersey is looking to add a new Senior Pharmacovigilance Associate to their growing team. In this role, the Senior Pharmacovigilance Associate will be responsible for monitoring, processing, controlling, and reporting individual case safety reports and aggregate safety reports for company products.
Responsibilities: The Senior Pharmacovigilance Associate will:
Review 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
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)
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
Assist 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
Prepare/review SOP, WI ? ICSR processing for Clinical trial cases
Qualifications:
RPh, Pharm.D, RN or related degree in a Scientific field
Knowledge of safety concepts, per ICH and FDA guidelines per device safety reporting requirements
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.
Great interpersonal skills
Excellent communication skills (written and verbal)
Strong attention to detail
Highly organized
Desired Skills:
2+ years of experience within a Pharmaceutical, CRO, or Healthcare environment