Pharmacovigilance Clinician
Hippocratic AISalary not specified
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, HealthcareIndustries
Requirements
Candidates must possess a Medical Doctorate (M.D.) degree or equivalent, with preferred therapeutic experience in Neurology/Psychiatry. A minimum of 10 years of Pharmacovigilance experience is required, including at least 5 years in a leadership or management role. Strong clinical judgment, organizational abilities, high credibility, significant leadership potential, and experience supervising drug safety processes from development to implementation are essential. Knowledge of regulatory agencies, ICH and GCP regulations, and prior experience with Drug Safety databases are also required.
Responsibilities
The Vice President, Pharmacovigilance will design and develop the company's Drug Safety and Pharmacovigilance function, implementing safety surveillance programs and risk management activities. Responsibilities include developing and executing a strategic vision for the department, providing subject matter expertise, and ensuring compliance with global pharmacovigilance regulations. The role involves overseeing safety data collection, evaluation, and analysis, leading the preparation and submission of safety reports, and developing risk management strategies. Additionally, the position entails leading signal detection activities, conducting benefit-risk assessments, collaborating with cross-functional teams, providing pharmacovigilance expertise in regulatory interactions, and ensuring compliance with all relevant guidelines and regulations.
Skills
Pharmacovigilance
Drug Safety
Regulatory Compliance
Risk Management
REMS
Safety Surveillance
Clinical Trials
Post-marketing Surveillance
Biotechnology
CNS Disorders
Leadership
Team Management
Abata Therapeutics
Develops therapies for autoimmune diseases
About Abata Therapeutics
Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.
Cambridge, MassachusettsHeadquarters
2021Year Founded
$184.8MTotal Funding
EARLY_VCCompany Stage
BiotechnologyIndustries
11-50Employees