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Executive Director, Pharmacovigilance Safety Physician

4 months ago

Bedminster, United States INTRA-CELLULAR THERAPIES INC Full time
Job DescriptionJob Description

Benefits Offered

401K, Dental, Life, Medical, Vision

Employment Type

Full-Time

“We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders”

Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize winning research, we launched our first commercial product in CNS in 2020 and received approval for an expanded indication in 2021. Currently celebrating our 22nd anniversary, we have a strong pipeline with projects in preclinical development stage through Phase III. We celebrate science, welcome curiosity, expect collaboration and demand integrity and respect in all we do, create and deliver.

The Executive Director, Pharmacovigilance Safety Physician (PVSP) serves as the medical safety expert for Intra-Cellular Therapies, Inc. (ITCI) assigned products. The PVSP provides guidance for medical review of post marketing individual case safety report (ICSR) and analysis of periodic reports to ensure patient safety and achieve compliance with ITCI Standard Operating Procedures (SOPs) and global regulations. The PVSP applies medical judgment in the analysis and interpretation of all available safety data to maintain the safety profile and communicate regarding benefit-risk. The PVSP contributes to safety surveillance, signal management and risk management strategy. The PVSP leads the cross-functional Safety Management Team (SMT) and plays a key role in product life-cycle management and benefit-risk assessment. This is a hybrid position with expectation of attendance in the office twice a week.

Responsibilities

  • The Pharmacovigilance Safety Physician is responsible for ongoing evaluation and analysis of all available safety data for development compounds and marketed products.
  • Serve as medical safety expert providing strategic input to key stakeholders regarding product safety.
  • Responsible for ongoing evaluation and analysis of all available safety data throughout the product lifecycle for assigned products.
  • Monitor the safety profile of assigned products to communicate the benefit-risk balance to prescribers, patients, consumers and study subjects through ongoing review of all available safety data.
  • Apply medical safety expertise during the review of Individual Case Safety Reports (ICSR)
    1. Review serious unexpected ICSRs to ensure medically concise and cohesive narrative, confirm seriousness, expectedness, coding (e.g., reaction, suspect/concomitant product, indication, laboratory data, medical history) and company comment or company causality assessment for non-interventional solicited reports (e.g., patient assistance programs, market research, etc.).
    2. Review of ICSR source documentation as required.
    3. Review follow-up queries to ensure pertinent information is requested to complete medical assessment of ICSRs.
    4. Perform aggregate review serious expected/non-serious cases.
    5. Develop and implementing Targeted Follow-up Questionnaires.
  • Participate in review of scientific literature to identify case reports that meet criteria for entry into the safety database; identify relevant safety articles involving marketed products and products in development that contain safety information which may be relevant to the safety of the drug and/or impact the product safety profile.
  • Communicate to stakeholders regarding events of interest, designated medical events, and sentinel events for assigned products.
  • Support and collaborate with cross-functional teams on safety related activities including presenting safety data at internal meetings and providing responses to health authority requests.
  • Analyze and interpret ICSR and/or aggregate safety data on an ongoing basis and communicate analysis and interpretation to cross-functional teams to support benefit-risk assessment.
  • Contribute to signal management activities i.e., detection, validation, assessment, confirmation and action plan/ risk management strategies.
  • Lead cross-functional safety management team (SMT) meetings which continuously monitors the product safety profile for comprehensive assessment of the benefit-risk, escalate relevant safety issues (e.g., safety signals, safety crisis, emerging safety issues) to the Medical Safety Governance Board.
  • Collaborate with the Drug Safety and Pharmacovigilance Operations leadership and key stakeholders to develop the risk management strategy and implement risk minimization measures for assigned products.
  • Review and contribute to safety sections within Clinical documents such as Investigator’s Brochure, Study Protocol, Informed Consent Forms, DSMB charter, IND Annual Report, Integrated Summaries of Safety, Clinical Study Reports.
  • Review and contribute to development of Safety and Regulatory documents such as periodic reports (e.g., DSUR, PADER, NDA Annual Report CCSI/CCDS/USPI, etc.).
  • Responsible for key safety content in risk management documents (RMPs, REMS) for assigned products, where applicable.
  • Contribute to the development of safety related documents such as safety management plans, safety monitoring plans, benefit-risk assessments and ad-hoc requests, etc.
  • Closely collaborate with Clinical Development Study Physician or Study Director to obtain and share information which may impact the safety profile and/or overall benefit-risk of assigned products.
  • Write/review safety communications e.g., “Dear Health Care Provider” letters.
  • Provide support for regulatory authority inspections, and responding to health authority requests, as required.
  • Review and/or implement effective corrective and preventative action (CAPA), where required.
  • Effectively manage vendors from the selection process through content development phase.
  • Participate in development and maintenance of SOPs and guidance documents.
  • Identify opportunities for continuous process improvement and recommend strategies to improve performance.
  • Participate in ad-hoc projects or assignments that require medical safety expertise (e.g., health hazard evaluation, etc.).
  • Ensure compliance with relevant regulations, guidelines and internal SOPs.
  • Maintain pharmacovigilance expertise (via research, benchmarking, and continuously seeking industry knowledge) to ensure knowledge is aligned with current regarding regulatory requirements.
  • Complete all company and job-related training as assigned within the required timelines.
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

The role requires strong collaboration skills to work with key stakeholders in managing patient safety and benefit-risk for ITCI products. Strong partnerships and open communications with Clinical Development, Clinical Operations, Data Management, Clinical Pharmacology, Toxicology, Regulatory Affairs, Medical Affairs, Quality Assurance, Biostatistics, Legal, Sales and Marketing, service providers, vendors, contract research organizations (CROs) and external partners required to ensure they are informed of evolving safety issues and strategies.

Requirements

  • United States Doctor of Medicine (MD)/Doctor of Osteopathic Medicine (DO) US licensure is required.
  • Minimum 10 years of relevant experience in drug safety/pharmacovigilance and/or clinical development within the biotechnology or pharmaceutical industry is required. Neuroscience experience is preferred.
  • Minimum 3 years of prior safety physician experience leading safety deliverables and safety management team for a product is required.
  • 1-2 years of Clinical Patient Care experience is preferred.
  • Previous experience with both clinical and post-approval products preferred.
  • In-depth knowledge of global regulatory requirements, ICH guidance, good pharmacovigilance practices (GvP), good clinical practices (GCP) and other relevant regulatory guidance.
  • In-depth knowledge of drug development process, safety surveillance and benefit-risk analysis are required.
  • In-depth knowledgeable of individual case safety report medical review, regulatory reporting, MedDRA coding, aggregate data review/reporting, signal management, risk management and safety labeling/reference safety information is required.
  • Experience with the reviewing and/or contributing to clinical, regulatory and safety related documents e.g., IB, Study protocol, ICF, DSURs, IND Annual Report, ISS, CSR, DSUR, PSUR/PBRER/PADER, NDA Annual Report, RMPs, REMS, CCDS/CCSI/USPI, SMPs.
  • Experience in providing benefit-risk assessment and drafting responses to health authority inquiries is preferred.
  • Experience in addressing and managing complex medical safety issues in the pre-approval and post-approval environment.
  • Experience supporting audits and/or health authority inspections and responding to Health Authority requests.
  • Ability to work independently, and collaborate effectively with key stakeholders, including cross-functional team members, business partners and vendors.
  • Flexible team player with the ability to influence and negotiate.
  • Ability to effectively apply clinical knowledge.
  • Ability to effectively manage competing priorities and meet deadlines.
  • Strategic thinking, strong writing and analytic skills, sound decision making and judgment, accountability, attention to detail, excellent verbal, written communication skills, collaboration, strong planning and organizing skills, excellent meeting facilitation skills.
  • Proficient with Microsoft Office.
  • Ability to travel at least 10% of the time.
  • Must be able to perform all essential functions of the position, with or without reasonable accommodation.

Intra-Cellular Therapies is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability or any other legally protected status.

Pharmacovigilance Safety Physician: Base Salary Range $250K-315K

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