Director, Pharmacovigilance Scientist

Company Overview:

Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company focused on developing innovative solutions for patients and healthcare providers in the fields of Critical Care and Infectious Diseases.

Our mission to deliver innovative, life-saving medicines for serious unmet medical conditions drives us every day and contributes to building a sustainable business for the long term. It also inspires our entrepreneurial culture which fosters innovation, collaboration, and a relentless commitment to the people we serve. Patients are at the center of everything we do because everyday matters. Every employee is encouraged to take initiative, explore new ideas, and turn challenges into opportunities that can potentially transform lives, especially those suffering serious, difficult-to-treat illness

Our products marketed in the U.S. include:

GIAPREZA (angiotensin II) is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock.

XACDURO (sulbactam for injection; durlobactam for injection) is a new treatment designed specifically to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex in adults.

XERAVA (eravacycline) is a broad-spectrum antibiotic used to treat patients with complicated intra-abdominal infections (cIAI).

Our latest addition to the Company's expanding antibiotic portfolio is ZEVTERA (ceftobiprole), a newly approved advanced-generation cephalosporin antibiotic. ZEVTERA is the only FDA-approved cephalosporin specifically designed to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI), adult patients with Staphylococcus aureus bloodstream infections (bacteremia) including those with right-sided infective endocarditis, and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). We anticipate a U.S. launch in mid-2025.

Innoviva Specialty Therapeutics development pipeline includes zoliflodacin, an investigational first-in-class oral antibiotic being developed for the treatment of uncomplicated gonorrhea infection in patients.

At Innoviva Specialty Therapeutics, Inc., we are building a culture dedicated to delivering products that address critical medical needs. If this is your passion, come and join us to make a difference.

Summary of Position:

The Director, Pharmacovigilance Scientist supports assigned compounds and leverages clinical and scientific expertise to support safety signaling and evaluation, development of aggregate reports and responses to regulatory inquiries, and clinical trial safety operations. In this role, you will apply effective prioritization, critical thinking, and judgment-based decision making to execute key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal and external stakeholders are important capabilities for this role.

Responsibilities:

Signal and Safety Data Evaluation

• Lead the routine identification and analysis of safety signals including oversight of relevant vendor(s).
• Lead the preparation of safety data for safety governance meetings (Safety Management Teams, etc.).
• Support the development, update, and review of safety communication documents (e.g., Dear Investigator Letter, Informed Consent Form, Investigator's Brochure, Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Physician and relevant cross-functional team members.

Clinical Trials

• Lead the development of clinical trial Safety Management Plans for assigned programs.
• Support the writing and review safety sections and provide safety expertise for development of clinical trial documents including Protocols, IBs, ICFs, CSRs, etc.
• Support the review of safety data and monitor the safety of patients on allocated clinical trials.

Aggregate Reports and Responses

• Lead coordination of aggregate reports such as Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report (PADER), and Periodic Benefit-Risk Evaluation Reports (PBRERs) including oversight of vendor, timelines, cross-functional contributors and reviewers, partners, and analysis of safety data. Author relevant safety sections as needed.
• Support strategy development, analysis, and response to safety questions from health authorities, IRBs/ECs.
• Contribute to integrated Benefit/Risk assessments.

Departmental Operations and Cross functional collaboration

• Support PV Operations with case reviews, review and/or maintenance of vendor plans, development of guidance documents, coding reviews, etc. as assigned.
• Lead or support various department initiatives such as internal process development, generation of metrics, and audit/inspection readiness activities.
• Support development of cross functional documents such as Health Hazard Evaluations, Briefing Books for HA interactions, NDA/MAA (SCS/ISS, RMPs, initial Package Inserts).
• Responsible for effective execution and communication with internal stakeholders (e.g., clinical development, medical, regulatory, labeling) and external stakeholders (e.g. FDA, partners, vendors, etc.).

Experience & Education:

• Bachelor's or higher healthcare-related degree (Nursing, Pharmacy, MD, MPH, etc.)

• 10 plus years of experience in the pharmaceutical industry with a minimum of 5 years of experience in pharmacovigilance

• Experience providing leadership in teams or committees such as a Safety Management Team and leading projects such as development of an initial RMP, aggregate reports, or process improvement initiatives
• Experience and extensive working knowledge of MedDRA and proprietary safety databases, PV processes for individual case review, signal detection and evaluation, aggregate report development, review and reporting, as well as clinical study safety management
• Experience with the compilation, writing and reviewing of safety documents such as DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, submission documents and safety labels
• Experience with audits and inspections preferred

Skills and Abilities:

• Strategic thinking, strong organizational and analytic skills, and project management
• Excellent verbal and written communication skills with strong attention to detail
• Demonstrate knowledge and application of pharmacovigilance principles to related tasks that are high in complexity.

• Strong scientific background and aptitude for learning
• Team player, who can be hands on with project implementation

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Innoviva Specialty Therapeutics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.