Abata Therapeutics

Vice President, Pharmacovigilance

Remote

Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, HealthcareIndustries

Who We Are

MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.

What You’ll Do

MapLight is looking for a dynamic and experienced Vice President, Pharmacovigilance to manage and oversee the company's drug safety activities. Reporting to the Chief Medical Officer (CMO) the Vice President, Pharmacovigilance will design and develop MapLight’s Drug Safety and Pharmacovigilance function; implementing safety surveillance programs and risk management activities to ensure the safety and efficacy of our neurological and psychiatric therapies throughout their lifecycle.

This senior leadership position requires a strategic thinker with extensive experience in pharmacovigilance, regulatory compliance, and risk management. The successful candidate will collaborate closely with cross-functional stakeholders to uphold the highest standards of drug safety and regulatory compliance.

Responsibilities

  • Develop and execute a strategic vision for the Pharmacovigilance department, aligning with the company's objectives and industry best practices.
  • Provide subject matter expertise to internal stakeholders and ensure compliance with global pharmacovigilance regulations and guidelines.
  • Eventually lead and mentor a team of pharmacovigilance professionals, fostering a culture of collaboration, excellence, and continuous improvement.
  • Oversee the collection, evaluation, and analysis of safety data from clinical trials, post-marketing sources, and other relevant sources.
  • Lead the preparation and submission of expedited and periodic safety reports to health authorities, ensuring accuracy, completeness, and timeliness.
  • Develop and implement risk management strategies, including REMS (Risk Evaluation and Mitigation Strategies), to minimize potential safety risks.
  • Lead signal detection activities to identify potential safety signals by analyzing safety data from various sources, including clinical trials, investigator-initiated trials, compassionate use programs, comparable products, and real-world evidence.
  • Conduct comprehensive benefit-risk assessments to inform decision-making and regulatory interactions.
  • Collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, and other departments to ensure effective communication of safety information and alignment on safety strategies.
  • Provide pharmacovigilance expertise in regulatory interactions, including Health Authority meetings and audits.
  • Ensure compliance with global pharmacovigilance regulations and guidelines, and drive the development and maintenance of pharmacovigilance SOPs and processes.
  • Lead pharmacovigilance audits and inspections, ensuring timely and accurate responses to regulatory inquiries.
  • Prepare and submit high-quality safety reports, including periodic safety reports (PSURs/PBRERs), development safety update reports (DSURs), and ad-hoc safety communications to regulatory authorities.
  • Develop and define SOPs and departmental procedures and ensures the uniform and timely processing of adverse event reports.

Qualifications

  • Medical Doctorate (M.D.) degree or equivalent.
  • Relevant therapeutic experience in an academic or hospital environment in Neurology/Psychiatry preferred.
  • 10+ years of Pharmacovigilance experience, with at least 5 years in a leadership/management role with a thorough understanding of Drug Safety department dynamics
  • Excellent clinical judgment, strong organizational abilities, high credibility and significant leadership potential
  • Experience supervising the drug safety processes from development to implementation.
  • Experience with regulatory agencies and knowledge of ICH and GCP regulations and prior experience with Drug Safety databases.
  • Knowledge of Good Clinical Practice (GCP)

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

Risks

Intensifying competition from companies like Sangamo Therapeutics may impact Abata's market share.
Stringent FDA scrutiny on manufacturing could delay Abata's clinical trials.
Rising clinical trial costs pose financial risks to Abata's pipeline progression.

Differentiation

Abata focuses on Treg cell therapies for autoimmune diseases like MS and diabetes.
Their lead product, ABA 201, targets type 1 diabetes with remaining beta cell function.
Abata's strategic partnership with ElevateBio enhances their manufacturing capabilities.

Upsides

Recent investment from Bristol Myers Squibb boosts Abata's Treg therapy pipeline development.
FDA's accelerated approval pathways may expedite Abata's clinical trials.
Growing autoimmune disease prevalence increases demand for Abata's innovative treatments.

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