The Senior Director, Drug Safety provides clinical expertise in the review and analysis of clinical study and post marketing safety information. S/He will participate in the review of individual case safety reports, prepare pharmacovigilance commentary and analysis, and contribute to the preparation of safety evaluations in aggregate reports.
The Senior Director, Drug Safety reports to the Vice President, Drug Safety and Pharmacovigilance, and represents the Drug Safety department in safety-related discussions with clinical investigators, IRBs/ECs, Data Monitoring Committees and health authorities. The Senior Director, Drug Safety contributes to the ongoing risk/benefit analysis of investigational drugs in clinical development and of marketed products.
This position will support one or more Myovant development programs and additional programs per business need.
Essential Duties & Responsibilities:
- Participation with senior management to establish strategic plans and objectives;
- Develop proactive risk management strategies for marketed and/or investigational compounds
- Contribute to a full range of pharmacovigilance (PV) activities for investigational product and marketed products, including operational activities, cross-functional activities with other departments (e.g., Biometrics, Clinical Operations, Clinical Development, Regulatory, Sales & Marketing), quality systems, audits and inspections;
- Provide updates of the assigned drug’s safety profile to senior management and recommend pharmacovigilance / risk management activities to corporate decision making bodies and the RPPV/EU QPPV, as applicable.
- Contribute to and review investigator’s brochures, safety sections of clinical study protocols, single and aggregate expedited reports, , development safety update reports, Periodic Benefit-Risk Evaluation Reports/PADERs, clinical overview statements, and risk management plans;
- Contribute to and review NDA and MAA-related safety documentation
- Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including:
- Continuous monitoring and further development of the product safety profile
- Safety issue management
- Set-up of safety analyses in both clinical trial and post marketing databases
- Close collaboration with Medical Affairs on safety-focused clinical and epidemiologic studies
- Contribute to and review safety data exchange agreements with alliance partners and safety management documentation for studies managed under an alliance, as applicable
- Direct drug safety management oversight (clinical study case process flow, reconciliation with clinical database) for specific clinical trials, as requested
- Depending on the status of development of the compound, lead, manage and medically-scientifically direct drug safety surveillance and management for a compound/product or project including project management, project-specific training and coaching of team members, review of team output
- Assesses the quality and accuracy of ICSR medical review, leads medical review meetings, provides ad hoc guidance to the ICSR medical reviewers; includes performance of clinical/medical case review, as required, for investigational and post marketing individual case safety reports, including reviewing the source records, reviewing the case narrative for accuracy, reviewing MedDRA coding for appropriateness, identifying medically relevant queries, confirming event “expectedness” based upon the reference safety information, preparation of sponsor assessment, and assisting drug safety staff in determining reportability;
- Create or review the Analysis of Similar Events for SUSARs subject to expedited reporting;
- Provide clinical input in signal detection and perform signal evaluation activities;
- Provide a clinical perspective at Safety Management Committee meetings;
- Contribute to meetings with Data Monitoring Committees, as requested;
- Lead team members, including Drug Safety Coordinators, Drug Safety Associates, to facilitate efficient case processing and other designated Drug Safety departmental tasks;
- Develop and conduct training as necessary;
- Maintain currency with applicable PV global regulations, and industry guidelines;
- Oversee preparation, development, implementation and maintenance of company standard operating procedures and policies relating to pharmacovigilance and risk management to ensure compliance with ICH guidelines and applicable regulatory requirements;
- Contribute to inspection readiness activities;
- Provide regular performance feedback as well as development and coaching to direct reports.
Core Competencies, Knowledge and Skill Requirements:
- Healthcare professional with clinical practice experience
- Experience writing pharmaceutical or health-related documents
- Knowledge of current US and international regulatory requirements
- Experience using computerized systems (PC-Windows and MS Office)
Communication & Interpersonal Skills:
- Excellent communication and interpersonal skills
- Interacts with Myovant employees, contractors and consultants.
Post-graduate degree (MD, DO) from an accredited institution.
- Minimum of 8 years of relevant industry experience which includes at least 5 years of senior drug safety experience.
- One (1) to three (3) years project leadership/management experience
- Experience writing safety sections of marketing applications, integrated summary of safety, DSUR/PSUR preferred.
- Very good and broad understanding of the pharmaceutical industry and the future trends and developments in Pharmacovigilance
- Board certification would be an asset
- Completion of a US residency or ex-US equivalent
- Active or inactive US license to practice medicine or international equivalent
- At least one (1) to two (2) years of clinical experience, beyond residency
Licenses or Certifications:
MD or DO
TRAVEL, PHYSICAL DEANDS AND WORK ENVIROMENT (AS APPROPRIATE FOR THE POSITION)