[Remote] Director, Pharmacovigilance Operations at Abata Therapeutics

Remote

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Health care professional degree (e.g. RN, BSN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or related life science
Preferred: Post-graduate training in business management or project management (MBA, PMP)
Minimum 8 years of pharmacovigilance experience within the biopharmaceutical industry with at least 3 years in leading PV operations
Preferred: Experience in neuroscience, psychiatry or neurodegenerative disease area
Competence in conducting safety data reviews, vendor management, preparation of aggregate reports, signal detection and risk management plans for investigational and/or post marketed products
Experience with MedDRA and drug coding reviews
Demonstrated expertise in global PV regulations, GVP and ICH guidelines, safety systems, and drug development processes
Experience in PV processes for individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections
Demonstrated PV project management skills in a fast-paced organization
Exceptional communication and cross-functional collaboration skills
Strategic thinker with the ability to translate complex safety data into actionable insights for regulatory and clinical decision-making
Able to work within a growing organization and to help the organization evolve over time
Able to engage in an open, constructive and continuous dialogue with the Company

Responsibilities

Develop strategy for PV operations and support PV Head in the implementation of strategy and vision for PV function
Provide strategic leadership for global pharmacovigilance operations, including case management, vendor oversight, and aggregate reporting
Manage the implementation of MPLT safety system (safety database and process) for regulatory compliant ICSR case processing
Oversight of PV vendor and contract management (e.g. third party CRO, partners)
Oversight of alliance management related to safety (SDEAs)
Manage flow of information and data between clinical and PV vendor in collaboration with Clinical operation (e.g. PV mailbox)
Oversight of quality and compliance for ICSR case processing and reporting (KPI)
Develop, contribute, review and maintain up to date ICSR case processing SOPs, forms, SMPs etc
Liaise with safety surveillance and cross-functional teams to support for timely dissemination of safety deliverables
Collaborate with Quality function and lead PV contributions for audit and inspections
Project management for PV functional deliverables
Oversight of PV functional contributions to TMFs
Manage PV budget and resources for PV vendor
Coach and mentor PV operation associates

Skills

Key technologies and capabilities for this role

PharmacovigilanceSafety Database ManagementICSR Case ProcessingVendor OversightAggregate ReportingSDEA ManagementRegulatory ComplianceSOP DevelopmentQuality AssuranceAudit PreparationProject ManagementClinical Trial Safety

Questions & Answers

Common questions about this position

What qualifications are required for the Director, Pharmacovigilance Operations role?

Candidates need a health care professional degree such as RN, BSN, or PharmD, or an advanced degree like Masters/PhD in biomedical sciences, pharmaceutical sciences, or related life sciences. Minimum 8 years of pharmacovigilance experience in the biopharmaceutical industry is required, with at least 3 years leading PV operations. Preferred qualifications include post-graduate training in business management or project management such as MBA or PMP, and experience in neuroscience.

What are the key responsibilities of this position?

The role involves leading PV operations strategy, managing safety databases and outsourced activities, overseeing vendors and alliances, ensuring quality and compliance for ICSR processing, developing SOPs, collaborating cross-functionally, and coaching associates.

What is the salary or compensation for this role?

This information is not specified in the job description.

Is this position remote or does it require office work?

This information is not specified in the job description.

What behaviors does the company seek in candidates?

The company seeks individuals who work effectively with cross-functional teams, have strong interpersonal skills, act as leaders who mentor others, and are team players willing to roll up their sleeves.

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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