Sr. Director, Medical Safety and Pharmacovigilance
Summary of job description:
Serve as the medical expert for the team in the management of safety signal, risk management activities, and benefit risk assessments for Replimune products. The Sr. Director, Medical Safety and Pharmacovigilance will report to the Head of Medical Safety and Pharmacovigilance and will be responsible for the conduct of safety monitoring and accountable for executing product related safety decisions and deliverables for assigned products.
- Serve as SME for product safety profile development and management, for medical safety case assessment, and for ongoing Signal detection, evaluation, and management
- Partner with the MSPV Safety Manager and PV Associate to ensure ICSR reviews are completed and on time for submission of expedited cases to RAs and exchanged with partner organizations
- Provide scientific expertise during signal detection activities, signal evaluation and risk assessment, and manage the process for the development and maintenance of product-specific Risk Management Plans
- Individual case safety report (ICSR) medical review, including vendor oversight for narrative content and Company comments
- Organize and direct liaison cross-functionally with Medical Monitors, medical writing, Clinical Operations, data management, Biostatistics, and Regulatory for management of safety reporting in compliance with global and regional regulatory requirements
- Ensure audit and inspection readiness for Medical Safety and Pharmacovigilance activities
- SME for development and maintenance of product-specific Development Core Safety Information, including assessment of adverse drug reactions (ADRs), identified and potential risks, and adverse events of special interest (AESI),
- Partner with clinical study Medical Monitors for safety oversight of clinical study subjects and evaluation of adverse events data
- Review and provide input on study protocols, statistical analysis plans, safety content of informed consent documents, Investigator and site training documents and presentations
- MSPV medical expert for SAE reconciliation and coding reviews, and assessment of expectedness of serious adverse reactions (SARs)
- Member of cross-functional Product Development Teams and responsible for product development strategy
- Contribute to CSRs and analysis of safety tables, figures, and listings and cases from clinical studies
- Represent Company in interactions with clinical Investigators and Data Safety Monitoring Committees, Regulatory Agency interactions as assigned
- Support activities related to new drug applications and other regulatory filings
- Contribute to Regulatory Agency information requests and safety content for regulatory filings, Summary of Clinical Safety and related documents.
- Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO and Pharmacovigilance scientist
- Prepare presentations to the Global Safety Team on safety issues
- Principal MSPV representative in the development of risk management strategy and activities, and safety-related regulatory activities
- Other responsibilities as assigned
- MD or equivalent degree from an accredited medical school
- Completion of internship and residency training program from an accredited institution
Experience and skill requirement:
- At least 4 years Clinical practice experience in either an accredited academic setting or private practice (including hospital based) setting
- At least 3 years’ experience in safety and pharmacovigilance in the bio/pharmaceutical industry, including ICSR review, causality assessment, and aggregate data review
- Expertise in oncology, immunotherapy and with viral vectors or other biologic agents preferred
- Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA regulations and guidelines, and other international regulatory requirements.
- Knowledge of MedDRA dictionary relevant to AE/SAE coding
- Experience with software-based drug safety systems (ARIS-G and/or ARGUS experience is required)
- Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
- Detail-oriented, with good organizational, prioritization, and time management proficiencies.
- Must be able to work on multiple projects simultaneously.
- Ability to prioritize work without much support.
- Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
- Proficient in standard computer software (Word, Excel and Power Point)
- Some travel may be required (<10%)
EEO & Employment Eligibility:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition.
Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.