View Our Website View All Jobs

Director/Senior Director, Global Drug Safety Operations

Position Summary:

This position reports to the Global Head of Drug Safety & Pharmacovigilance.  

The Senior Director of Global Drug Safety Operations will be accountable for ensuring effective, high quality and efficient management of drug safety operations’ deliverables and strategic planning for departmental needs, to ensure compliance with applicable global regulations and guidelines.  

 

Responsibilities:  

  • Provide strategic planning, implementation, and management of Drug Safety Operations activities.
  • Provides expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH; US and international regulations and guidelines; and Good Pharmacovigilance Practice (GPvP). 
  • Accountable for identification, development and implementation of pharmacovigilance (PV) process improvements, tools, systems and procedures to enable excellence and consistency in operations. 
  • Ensures implementation of standardized processes and procedures (SOP) for Drug Safety Operations activities to ensure global compliance, including Adverse Event (AE) processing and aggregate reporting.
  • Supervises operations personnel (direct reports, consultants) including mentoring and training.
  • Establishes PV CRO oversight procedures and Key Performance Indicators (KPIs).
  • Ensures that the PV Database supports the department needs and provides oversight of systems and MedDRA updates in collaboration with the relevant PV CRO.
  • Responsible for timeline management and ensuring global submission of aggregate safety reports and line listings such as DSURs and other aggregate safety reports (e.g.; PSURs/PBRERs) as required.
  • Supports training of department personnel and other line functions involved in AE collection or processing such as Medical Affairs, sales, medical information, etc.
  • Responsible for the creation, oversight and management of global business partner safety data exchange agreements/ pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange activity.
  • Develops and implements an inspection readiness program with the contribution of other PV and non-PV stakeholders.
  • Works with QA/Compliance to ensure compliance of Drug Safety Operations procedures and training.
  • Ensures compliance-related investigations, and development and implementation of corrective actions for deviations from case processing procedures are performed accurately and on time.
  • Participates in regulatory inspections and audits to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting requirements, including authoring of responses to findings relevant to functional area.
  • Participates in departmental budget planning and management.
  • Represents drug safety as a leader on project teams, other departments, and committees as needed.
  • Assists in the preparation of relevant sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents.
  • Provides expert safety/pharmacovigilance guidance to clinical trial project teams and/or external partners to develop procedures and logistics for clinical trials.
  • Effectively collaborates with key stakeholders at all levels in the organization.  including Clinical Operations, Clinical Development, Regulatory Affairs, Legal, Medical Affairs and Manufacturing  to develop compliant procedures in line with industry standards and best practices.

Requirements:

  • Advanced degree in life sciences, nursing, pharmacy or medicine, eg. PhD, PharmD, RN.
  • At least 7-10 years’ experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments. A minimum of 6 years of functional management experience overseeing PV staff.
  • Expert knowledge of FDA safety regulations, ICH Guidelines, Good Pharmacovigilance Practice (GPvP) and other applicable regulatory guidance documents.
  • Demonstrated ability to prioritize and solve problems with innovative solutions along with strong organizational skills.
  • Possess strong and dynamic leadership skills, with excellent written, verbal and presentation skills.
  • Effective team player, fosters collaboration within and across functional areas.
  • Sound strategic evaluation, analysis, and decision-making skills.
  • Able to handle pressure in a dynamic, fast paced environment.
  • Effectively formulates strategies, tactics and action plans to achieve results.
  • Ability to balance competing interests of various stakeholders and strive for achieving mutually beneficial and compliant solutions.

 

Read More

Apply for this position

Required*
Apply with Indeed
Attach resume as .pdf, .doc, or .docx (limit 2MB) or Paste resume

Paste your resume here or Attach resume file

150
To comply with government Equal Employment Opportunity / Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.
Gender
Race/Ethnicity

Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • 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.
Veteran status
I IDENTIFY AS ONE OR MORE OF THE CLASSIFICATIONS OF PROTECTED VETERAN LISTED ABOVE
I AM NOT A PROTECTED VETERAN
I DON’T WISH TO ANSWER

Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 1/31/2020
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 disabilities.i 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)
Please check one of the boxes below:

You must enter your name and date
Your Name Today's Date
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.


iSection 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.