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

 

Significant Contacts:

  • Interacts with Myovant employees, contractors and consultants.

 

Education

Post-graduate degree (MD, DO) from an accredited institution.

Experience: 

  • 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)

Apply for this Job

* Required
File   X
File   X
When autocomplete results are available use up and down arrows to review
+ Add Another Education


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at Myovant Sciences are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 1/31/2020

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

Because we do business with the government, we must reach out to, hire, and provide equal opportunity to qualified people with disabilities1. To help us measure how well we are doing, we are asking you to tell us if you have a disability or if you ever had a disability. Completing this form is voluntary, but we hope that you will choose to fill it out. If you are applying for a job, any answer you give will be kept private and will not be used against you in any way.

If you already work for us, your answer will not be used against you in any way. Because a person may become disabled at any time, we are required to ask all of our employees to update their information every five years. You may voluntarily self-identify as having a disability on this form without fear of any punishment because you did not identify as having a disability earlier.

How do I know if I have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Blindness
  • Deafness
  • Cancer
  • Diabetes
  • Epilepsy
  • Autism
  • Cerebral palsy
  • HIV/AIDS
  • Schizophrenia
  • Muscular dystrophy
  • Bipolar disorder
  • Major depression
  • Multiple sclerosis (MS)
  • Missing limbs or partially missing limbs
  • Post-traumatic stress disorder (PTSD)
  • Obsessive compulsive disorder
  • Impairments requiring the use of a wheelchair
  • Intellectual disability (previously called mental retardation)
Reasonable Accommodation Notice

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.