Global Drug Safety Medical Director

Location: 

AK-Offsite, US

Contract Type:  Regular Full-Time
Area:  Pharmacovigilance
Req Id:  387687

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Summary:

Performs medical reviews, assessments, and coordinates the distribution of product safety information on assigned investigational and marketed drugs from U.S. and global sources. Ensures the highest quality, accuracy and timeliness with respect to company and department SOP's and global regulatory guidelines.

 

Primary responsibilities:

  • Assesses adverse drug events with respect to seriousness relationship to drug product and global labeling status in order to assign appropriate case reporting status.
  • Monitors the collection, processing, review, and distribution of adverse event information regarding assigned developmental and marketed Grifols pharmaceutical products.
  • Assures the accuracy of adverse event information for assigned products in the global database and timely distribution of case information to Global Pharmacovigilance (GPV).
  • Establishes and maintains close liaison with GPV personnel in assigned product areas.
  • Develops and maintains in-depth knowledge of assigned pharmaceutical products.
  • Serves as a Medical contributor to submission of periodic safety reports to U.S. (FDA) and Global Regulatory authorities for assigned products.
  • Conducts periodic review of safety labeling for assigned products, particularly with regard to current product periodic safety update reports (PSURs) for the purpose of updating global labeling as required.
  • Assists in the development, performance, and ongoing review of safety signal detection procedures and activities for company products.
  • Identifies potential safety signals, develops and executes product safety signal investigations, presents findings and recommendations to management.
  • Supports GPV in the strategic development, medical assessments and implementation of risk management activities. 
  • Composes patient safety risk/benefit analyses and recommendations for individual adverse event case reports or aggregate reviews.  Provides medical expert statements supporting the requests of external departments.
  • Serves as a medical expert and mentor to junior GPV staff providing oversight, mentoring and training.
  • Supports GPV Clinical team with task related sponsored clinical trials. Includes review, input and sign off of study protocol, investigator brochures , inform content form, Safety management plans, study report, or submission documents supporting marketing approvals and activities for development company products.
  • Serves as Drug Safety SME for company sponsored clinical trials. 

 

Additional responsibilities for Level 2:

Serves as lead Drug Safety SME for company sponsored clinical trials, supporting clinical development medical staff. Expected to serve as the official delegate or "back up" SME in Drug Safety and Pharmacovigilance periodically.

 

Knowledge, skills, and abilities:

Level 1: In-depth knowledge in at least one therapeutic area relevant to company marketed products. Advanced knowledge of Food & Drug Administration (FDA) and international regulations governing drug safety reporting.  Excellent verbal and written skills. A skilled communicator and team player to develop and maintain cooperative relationships with internal and external customers.  Ability to problem solve when assessing adverse events and their ramifications for product use. Strong computer skills and solid working knowledge of MS Office suite. 

 

Level 2: In-depth knowledge in more then one therapeutic area relevant to company marketed products. Expert knowledge of Food & Drug Administration (FDA) and international regulations governing drug safety reporting.  Excellent verbal and written skills. A skilled communicator and team player to develop and maintain cooperative relationships with internal and external customers.  Ability to problem solve when assessing adverse events and their global ramifications for product use across multiple company business units. Ability to work in and drive teams in cross functional groups outside the Drug Safety business unit. Strong computer skills and solid working knowledge of MS Office suite

 

Requirements:

Level 1: Medical degree. Typically requires 8 years of drug safety, clinical research, or healthcare related experience. A minimum of 2 years must be derived from pharmaceutical industry experience directly related to adverse event reporting from either clinical trials or postmarketing, or a combination thereof.

 

Level 2: Medical degree. Typically requires 12 years of drug safety, clinical research, or healthcare related experience. A minimum of 4 years must be derived from pharmaceutical industry experience directly related to adverse event reporting from either clinical trials or postmarketing, or a combination thereof. 

 

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.  Example:  If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

 

Occupational demands:

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.   Occasionally walks and stands. Occasionally bends and twists neck.  Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences.  Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

 

EEO/Minorities/Females/Disability/Veterans

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