Sr. Manager/Associate Director, Drug Safety and Pharmacovigilance
Boston, MA, United States
Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data sciences, with the goal of consistently and rapidly creating exquisitely selective small molecule compounds against an unprecedented spectrum of targets. Scorpion aims to leverage its platform to advance a broad pipeline of wholly owned, optimized compounds across three target categories: best-in-class molecules targeting validated oncogene targets; first-in-class molecules for previously undruggable targets; and first-in-class molecules for novel cancer targets.
Position Overview:
Scorpion Therapeutics is seeking a highly experienced and motivated Senior Manager or Associate Director to join our Drug Safety and Pharmacovigilance team. The Senior Manager or Associate Director will be responsible for overseeing external service provider/s (ESPs) performing drug safety and pharmacovigilance activities across our portfolio of oncology therapeutics.
Key Responsibilities:
Oversee PV Operations external service provider's management of serious adverse events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), and AEs of clinical interest according to Safety Management Plans (SMPs).
Generate all case narratives, coordinate Scorpion case review, and organize queries for ESP's distribution to the sites and entering into the electronic data capture system.
Ensure the timely submission of expedited reports and other safety-related regulatory documents to all regulatory authorities, partners, and other applicable entities.
Interface with partners and ensure compliance with PV and safety data exchange agreements.
Support review of safety-related essential documents (e.g., IBs, ICFs, etc.) and other study-related listings (e.g., MedDRA coding of AEs, medical history, and concomitant medications)
Assist in data cleaning activities as required.
Develop and maintain Standard Operating Procedures (SOP), Forms, Templates, and Guidelines to ensure compliance, if needed.
Collaborate with applicable team members of functional groups to ensure completion of corrective and preventative actions.
Support signal management activities and benefit-risk evaluations and preparation of annual safety reports (e.g., DSUR).
Qualifications:
Advanced degree in pharmacy, medicine, life sciences, or related field is preferred.
Minimum of 8 years of experience in drug safety and pharmacovigilance within the pharmaceutical or biotechnology industry, with progressive leadership responsibilities.
In-depth knowledge of global pharmacovigilance regulations, guidelines, and best practices.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
Demonstrated ability to thrive in a fast-paced, dynamic environment and manage multiple priorities effectively.
Scorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Beginning October 13, 2021, Scorpion Therapeutics requires all new hires to be fully vaccinated against COVID-19. If you are unable to receive the vaccine due to a disability or serious medical condition, or because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
#J-18808-Ljbffr