Primary responsibilities include providing medical support for Pharmacovigilance (PV) activities for investigational and marketed products and promote the safe use of our products with the aim of optimizing overall benefit/risk. The Associate Director is responsible for global PV activities including: safety surveillance support, medical review of individual case reports, authoring and review of periodic safety reports, and medical safety support to Clinical Development and Medical Affairs.
ESSENTIAL DUTIES & RESPONSIBILITIES:
Perform a medical review of Individual Case Safety Reports (ICSRs) for assigned investigational and marketed products.
Review and approve PV Vendor draft listedness/ expectedness assessment, causality assessment, and Sponsor comment for investigational and marketed products.
Review and approve PV Vendor Preferred Term search criteria and draft Analysis of Similar Events (AoSE) for 15-day expedited safety reports.
Review and approve expedited safety reports for submission to regulatory authorities for investigational and marketed products.
Review Global Literature search output and drafted reports for marketed product.
Review of coding of adverse events, concomitant medications, and medical history, as needed, for consistency and medical appropriateness.
Provide various medical assessment support for investigational and marketed products, as needed.
Review of literature, risk, and signal logs.
Review signal detection reports.
Support periodic safety reporting including production and distribution of DSURs, PADER and PBRERs.
Support safety labeling related activities.
Support development and review of protocols, ICFs, and CSRs from a Pharmacovigilance perspective.
Assist in risk management plan development/updates and risk communication material development.
Assist in regulatory responses to safety inquires from regulatory agencies.
Ensure readiness for regulatory inspections and represent PV in inspections.
Support publications and scientific meetings as needed.
REQUIREMENTS:
Medical Doctor in a relevant field.
Minimum 5 years of Pharmacovigilance or Drug Safety and Risk Management and 6 years of Biopharmaceuticals industry experience.
Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA.
Proficiency in strategizing, planning, monitoring and problem solving.
Team-oriented with excellent communication and interpersonal skills, demonstrated ability in managing and influencing indirectly.
Flexibility to work in a fast-paced environment. Ability to manage multiple and diverse issues.
Strong facilitation, organizational, analytical and time management skills.
Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Visio.
Ability to apply knowledge to new situations.
Effective communication skills with the ability to articulate complex and broad concepts and translate into plans for action.
Ability to “roll up your sleeves” and individually contribute results in a team-based environment.
Experience authoring of documents, reports and presentations.
Knowledge of regulations governing pharmacovigilance and the ability to interpret and apply applicable regulations to maintain compliance.
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position. EOE
Internal Number: 1
About Heron Therapeutics
Our mission is to improve the lives of patients by developing novel, best-in-class treatments to address some of the most important unmet patient needs. We aim to develop patient-focused solutions by applying our innovative science and technologies with well-known pharmacology.
Our product portfolio includes the following:
SUSTOL® (granisetron) extended-release injection is approved by the U.S. Food and Drug Administration (FDA) and is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.
CINVANTI® (aprepitant) injectable emulsion, for intravenous use is approved by the FDA and is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of modera...tely emetogenic cancer chemotherapy (MEC).
HTX-011 is our long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of post-operative pain. Targeting both pain and inflammation has allowed HTX-011 to demonstrate an advantage over current standard of care in multiple surgical models-bunionectomy, hernia repair and abdominoplasty (tummy tuck)-in Phase 2 studies. Recently, Heron initiated patient enrollment in its Phase 3 program and anticipates completing the Phase 3 program in the first half of 2018. Heron expects to file an NDA for HTX-011 in 2018.
SUSTOL, CINVANTI, and our investigational product candidates utilize our innovative science and technology platforms, including our proprietary Biochronomer® drug delivery technology, which can deliver therapeutic levels of a wide range of otherwise short-acting pharmacological agents over a period of days to weeks with a single injection.
