Medical Director/Senior Medical Director, Pharmacovigilance

Innoviva Specialty Therapeutics•Waltham, MA

About The Position

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 from serious and difficult-to-treat illnesses. 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). ZEVTERA® (ceftobiprole) is an approved advanced-generation cephalosporin antibiotic and the only FDA-approved cephalosporin specifically designed to treat adult patients with Staphylococcus aureus bloodstream infections (bacteremia) including those with right-sided infective endocarditis. In addition, Zevtera is approved in adult patients with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). Nuzolvence® (zoliflodacin) for oral suspension is a first-in-class, single-dose oral antibiotic for the treatment of uncomplicated urogenital gonorrhea in adults and adolescents 12 years of age and older weighing at least 35 kg. Summary of Position: The Director/Senior Medical Director, Pharmacovigilance will provide medical and strategic leadership for safety oversight across both marketed and investigational products, including post-marketing clinical studies. This role serves as the medical authority for product safety, ensuring proactive risk management, regulatory compliance, and scientific rigor throughout the product lifecycle. The Director/Senior Medical Director partners cross-functionally with Clinical Development, Regulatory, Medical Affairs, Quality and other teams to ensure patient safety remains central to development and commercialization strategies.

Requirements

MD or DO is required.
10 plus years of relevant experience in drug safety, clinical safety and/or benefit-risk management within the biotechnology or pharmaceutical industry
Strong understanding of pharmacovigilance regulations in the US and EU, Good Pharmacovigilance Practices, .
Strong drug safety database and MedDRA coding experience required
Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies.
Demonstrated ability to prepare scientific / regulatory documents from large volumes of scientific data
Proficiency in Microsoft Office applications and Adobe Acrobat
Excellent communication skills (verbal and written), with the ability to convey complex medical and safety information clearly to diverse audiences.
Highly organized, self-directed, and detail-oriented, with strong analytical, critical thinking, and problem-solving skills.
Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance

Nice To Haves

Additional advanced degree (for e.g. MPH, PhD) is a plus.
Patient care experience preferred, with experience in infectious disease or critical care a plus

Responsibilities

Lead and support PV Scientist(s) through direct management, mentorship, and guidance.
Conducts medical review of reports of adverse events, special situations, and other safety information including assessments, review of coding using MedDRA and WHO Drug, and review of the narratives for medical completeness and accuracy
Lead the Safety Management Team and safety governance / escalation processes.
Collaborate within PV and cross-functionally with Clinical Development, Regulatory Affairs, Medical Affairs, CMC, Quality, and other stakeholders to identify, evaluate, and manage safety signals, including participation in Health Hazard Assessments and risk management activities
Lead assessment of safety issues arising from spontaneous reports, literature, quality complaints, or post-marketing data, including benefit-risk evaluations and regulatory decision-making.
Contribute medical expertise to product labeling including Company Core Data Sheets (CCDS); lead determination of the Adverse Reactions sections and contribute to other safety-relevant labeling updates.
Provide medical review and oversight of aggregate safety reports, including PSURs, PBRERs, DSURs, ASRs, and integrated safety summaries.
Lead signal detection activities including oversight of activities performed by PV Scientist(s) and vendor(s)
Provide medical expertise in responses to Health Authority queries, inspections, and senior management safety inquiries.
Support inspection readiness, audit activities, and continuous improvement initiatives within the safety function.
Provide expert medical advice across programs and contribute to strategic safety planning to support timely and high-quality delivery of clinical and commercial objectives.
Perform additional duties as assigned consistent with the scope and level of the role.