Senior Pharmacovigilance Director
1 day ago
**Job Summary:**
We are seeking a highly experienced Director, Pharmacovigilance Scientist to join our Global Drug Safety function. In this critical role, you will lead pharmacovigilance activities for developmental compounds and/or marketed products, developing and maintaining comprehensive safety surveillance and signal detection plans.
**Responsibilities:**
* Leads PV Scientist activities of cross-functional project teams for developmental compounds and/or marketed products.
* Collaborates with the Global Safety Physician (GSP) to develop, maintain, oversee, and execute the comprehensive safety surveillance and signal detection plan for assigned products.
* Authors and contributes safety sections and other relevant content to Investigator Brochures, Protocols, Informed Consents, and Clinical Study Reports.
* Leverages expertise in pharmacovigilance and risk management planning for ADC Therapeutics products, including preparation of the safety aspects of Risk Management Plans with applicable License Partners as appropriate and REMS if applicable.
* Supports multidisciplinary SST and SMT and escalation of all relevant safety matters to the appropriate decision-making level, providing appropriate proposals for solutions based on analysis of the available information and in collaboration with the GSP.
* Additional projects as assigned.
**Requirements:**
* Bachelor's in sciences/pharmacy/nursing degree or related field Bachelor's degree in health-care related discipline or equivalent.
* RN, R.Ph., or Pharm D. degree is highly preferred.
* 8+ years of proven pharmacovigilance experience, preferably in oncology.
* Patient Safety and/or Clinical/Drug Development with proven experience working in safety &/or scientific activities in at least 3 of the following areas:
* Clinical drug development (Early and/or Late Phase: develop & deliver program level safety strategy, including proactive risk identification & mitigation planning).
* Post-Marketing Surveillance (including signal detection & evaluation).
* MAA/BLA (preparation and authoring of the safety related aspects of the Common Technical Document).
* Periodic Safety Reports (deliver strategy, preparation and authoring).
* Risk Management Plans (deliver strategy, preparation and authoring).
* Safety governance board interactions and communication across a range of activities.
* Demonstrated ability to handle more than one activity simultaneously, prioritizing and recognizing key issues.
* Ability to work effectively in an advanced matrix structure.
* Proficient in expressive and receptive communications in English language.
* Experience authoring safety signal assessment report, DSUR, PBRER, RMP, and RSI.
* Skilled in signal detection process and managing safety information from clinical development and post-marketing sources.
* Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management.
* Knowledge of drug development process, pharmacovigilance databases and MedDRA coding.
* Experience with use of safety databases, preferably Argus Safety Database.
* Documented experience in multiple trials with safety inputs at the Global level.
* International experience from a similar role with internal and external stakeholders.
* Participate in audit preparedness activities and serves as subject matter expert during regulatory inspections in collaboration with team members.
* Expert level proficiency in reporting and data analysis tools, including Excel.
$140,000 - $180,000 per year (estimated salary range based on location and industry standards).
**What You'll Do:**
You will play a critical role in supporting the safety strategy and requirements for your assigned drug project(s), collaborating with cross-functional teams, and contributing to the development of comprehensive safety surveillance and signal detection plans.
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