Sunovion Senior Drug Safety Physician in Marlborough, Massachusetts
Sunovion Pharmaceuticals is looking for a Senior Drug Safety Physician to join our Pharmacovigilance and Risk Management (PVRM) department in Fort Lee, NJ or Marlborough, MA.
The Senior Drug Safety Physician in the Department of PVRM is responsible for monitoring and managing the safety profile of both investigational and marketed products at Sunovion Pharmaceuticals, Inc. (Sunovion). This includes timely review, analysis, and synthesis of drug safety data, identification and investigation of potential safety signals, and establishment of benefit-risk profiles and prevention/mitigation strategies. This individual serves as medical safety advisor to research and development teams throughout the product life cycle, escalating safety concerns within the organization according to established safety governance policies and keeping senior leadership informed of safety issues. This individual performs the above duties with minimal direction or supervision and reports to the Head, PVRM and Head, Global Pharmacovigilance.
Maintains current knowledge of applicable local/global regulatory regulations and guidance
Conduct safety surveillance over product life cycle, reviewing clinical trial and post-marketing Individual Case Safety Reports (ICSRs), including Adverse Event Reports (AEs), Serious Adverse Event Reports (SAEs), and Product Complaints (PCs)
Analyzes aggregate safety data from clinical trial reports and from spontaneous post-marketing sources (providers, patients, caregivers, medical literature, industry partners, and vendors/contractors)
Collaborates with Safety Scientists to manage analysis of clinical and post-marketing safety data, provides medical assessment, and instructs staff on appropriate query and follow-up activities
Collaborates with Clinical Development and Clinical Operations teams on safety of clinical studies to ensure accuracy, completeness, and quality of Clinical Trial ICSRs
Leads and/or contributes to medical safety of clinical trials, including monitoring of clinical trial safety and laboratory data
Generates safety queries, evaluates safety data and contributes/authors safety statements as a medical safety subject matter expert (SME) on behalf of PVRM for:
Informed Consent Forms (ICF)
Safety Management Plans (SMP)
Clinical Study Reports (CSR)
Investigator's Brochures (IB)
Investigator communications (Dear Health Care Provider letters - DHCP)
Aggregate Reports (PADER, PSUR, PBRER, DSUR, IND/NDA Annual Reports)
Company Core Data Sheets (CCDS)
Locally approved labels such as, United States Prescribing Information (USPI), European Summary of Product Characteristics (SmPC), and Canadian Product Monograph (PM)
Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, adverse event coding, concomitant medication coding, and causality statements
Contributes to Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategy (REMS)
Contributes to PVRM and cross-functional drug development teams and manages Safety Charters
Fields safety questions from Institutional Review Board (IRB)/Ethics Committee and Investigators
Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries
Ensures consistency, quality and integrity of safety data assessment, data analysis, and reporting for compounds in development and marketed products
Represents PVRM on post marketing product specific and/or clinical study team meetings and governance committees (Monthly Safety Management Teams, Quarterly Executive Safety Committee)
Performs aggregate review of post-marketing safety data in support of safety signal validation, trend detection, risk benefit management, and development of risk mitigation strategies
Develops and maintains collaborative relationships with colleagues in Pre-Clinical Safety, Clinical Development, Clinical Operations, Regulatory, Clinical Pharmacology and Medical Affairs and broadly
Ensure timely submission of expedited ICSRs and periodic aggregate ADR reporting for clinical trials and post-marketing experience as required by local and global regulations.
Participates/contributes to other activities such as literature evaluation, investigator site training, continuing education for internal staff, inspection/audit readiness, audits, and inspections
Prepares and presents safety information (i.e. safety graphs, tables and reports) to project teams and senior management, pertaining to the safety profile of therapeutically assigned compounds/products
Reviews and updates PVRM Standard Operating Procedures and process enhancements as needed
Leads/manages PVRM external vendor's Medical PV operations group
Leads Safety Team within PVRM and the Global Analytics Function
Manages Associate Drug Safety Physician and PVRM Safety Scientists
Minimum Education, Experience, Knowledge and Skills Required:
Medical Degree (MD) with 7 to 10 Years drug safety experience in a pharmaceutical company
Advanced understanding of pharmacovigilance and risk management regulations and guidelines, including pre- and post-marketing US FDA and/or EU ICH safety requirements
Knowledge of drug development in the pharmaceutical industry, including clinical research and global regulatory requirements
Experience managing safety data, expedited individual and aggregate periodic safety reporting, signal generation, safety evaluation and risk management and mitigation strategies
Experience in CNS (Neurology & Psychiatry) and/or Respiratory therapeutic areas highly desired
Ability to travel both domestically and internationally as required
Ability to work effectively across the development functions in teams, strong interpersonal skills and the ability to lead directly or indirectly with influence
Strong problem solving, conflict resolution and analytical thinking skills
Excellent computer skills with in-depth experience using safety database preferred
Strong communication skills and scientific/business acumen.
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer. Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.