Associate Director, Safety Operations

Location
Emeryville, CA, United States
Posted
Feb 03, 2021
Ref
1045
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
COMPANY DESCRIPTION:

At Santen, we’re innovating therapies to improve the quality of life for patients worldwide. Our single focus in ophthalmology enables us to challenge unmet needs in the field—through passionate research, successful collaboration, and clarity of commitment. With over 130 years of investigative insight, Santen remains committed to the discovery, exploration, and development of ophthalmic therapies. As a global company, Santen is expanding to accommodate new and evolving initiatives in ophthalmic research, regulatory management, production, marketing, or distribution. Our clinical development network spans three continents, with centers in Europe, Japan, and the United States.

We are in search of top talent to help us meet our aggressive and important goals.

ABOUT THE POSITION:

The Associate Director is responsible for implementing and coordinating pharmacovigilance activities for Santen medicinal products and device devices including intraocular lenses, minimally invasive glaucoma stents, and insertion device products. Responsibilities for the Associate Director include ensuring corporate compliance with domestic and international adverse event and safety issue reporting requirements, interpreting the medical significance of incoming safety information, and performing regular risk management assessments of assigned products. The Associate Director will supervise activities of subordinate safety operations personnel, contractors, and contract research organizations involved with performance of safety activities. In addition, the Associate Director may participate in preparing assigned regulatory and ad hoc safety reports and serving as a safety information resource person to Clinical Development Teams and business partners on assigned projects and overseeing clinical assessments of other pharmacovigilance personnel. The position will help support product specific safety analyses including medical evaluation, risk management, signal detection using epidemiology and other input as appropriate to ensure adequate safety measures are implemented based on data..

ESSENTIAL DUTIES AND KEY DELIVERABLES:
  • Participation in local and global safety vigilance task forces with responsibilities for maintaining and upgrading safety vigilance processes. These may include MedDRA maintenance, Safety systems policies, and implementation of new regional and cross-regional safety regulations.
  • Provides support and will lead activities for health authority inspection preparation for as required for product approval licensing activities, periodic regulatory authority inspections audits and for project product recall activities.
  • Ensures corporate compliance with domestic and international adverse event and safety issue reporting requirements for delegated products.
  • Prepares safety-related sections and associated documentation for clinical and regulatory documents (i.e. clinical study protocols, clinical study final reports, IND annual reports, integrated summaries of safety, annual safety reports, Investigator Brochures, US Periodic Adverse Drug Experience Reports (PADER), Product Safety Update Reports (PSUR), Development Safety Update Reports (DSUR), and Annual safety update reports (ASUR), and other aggregate reports).
  • Reviews ICFs, clinical study non-serious adverse event line listings and other study related documents containing safety information.
  • May assist with approving, reviewing, and contributing to publications (abstracts, posters, papers) for scientific meetings/journals.
  • Help with managing the department relationship with internal and external business partners to meet global regulatory reporting requirements and support other Santen business areas, including Safety Data Exchange Agreements (SDEAs) .
  • Supervise local case safety operations activities including management of case processing personnel and personnel related to licensing partners and CROs.
  • May act as Product Safety Lead with responsibility for signal detection and assessment activities for development or commercial Santen products. Such activities may include preparation of signal assessment and validation documents such as signal summary reports; tracking and using safety database tools for aggregating safety data; leading cross functional teams to assess safety signals; creation of action plans to mitigate/manage product risks; responding to safety associated Health Authority requests; development and maintenance of product Risk Management Plans (RMP); monitor the safety profile of delegated products and recommend appropriate action including labeling amendments and risk management programs when warranted assess product specific adverse event information to determine required action based on internal policies; and providing medical assessment as relevant.
  • Assists with contributing to safety components of strategic documents and to development of Target Product Profile (TPP).
  • Act as the safety liaison/resource on study project teams for safety related issues relating to clinical development.
  • Participates in the creation of the organizational strategy, goals, and objectives for the department, and assists in the implementation of the business plans to support both local and global safety strategies (i.e., rollout of new safety initiatives, implementation of new Health Authority safety requirements).
  • Collaborates with other departments (e.g., training) to provide expertise and guidance to personnel for interdepartmental and cross-functional team activities, including process improvement standards and metrics.
  • Interacts with other Santen Affiliates and service providers as required to address safety queries, share best practices, and discuss new safety regulations.
  • Support other areas as needed (Clinical operations, medical sciences, biometrics, etc.) Will also be expected to further develop own potential succession candidate.

QUALIFICATIONS:
  • MD, PharmD., RN, BSN, Nurse Practitioner, Pharmacist or related degree with at least 4 years pharmaceutical industry, pharmaceutical industry safety surveillance, or applicable clinical/medical experience required.
  • Ability to communicate US business and PV needs with cross-functional multi-region offices including Europe and Japan.
  • Demonstrated knowledge of domestic and international medicinal product AE/SAE and medical device MDR reporting regulations per guidelines and follow timelines as necessary for regulatory reporting purposes.
  • Demonstrated knowledge and proficiency with drug safety database (i.e. ARISg, ARGUS).
  • Proficiency with standard office skills and standard desktop computing programs.
  • Excellent oral and written communication skills with excellent interpersonal skills and willingness to work in a team environment.
  • Highly organized and demonstrates understanding of workflow prioritization.
  • Ability to multitask and triage as needed with the ability to work independently, under pressure, demonstrating initiative and flexibility.
  • Excellent understanding of clinical trial methodology, GCP and medical terminology.
  • Attention to detail and quality focused with strong technical and problem-solving skills.
  • Strong organizational and project management skills.
  • Strong communication skills and the ability to operate effectively in an international environment.
  • Medical writing experience required. Fluency in English. Knowledge of Japanese desirable.
  • Excellent understanding of physiology, pharmacology, clinical study objectives, and the drug development process.
  • Strong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety database applications.
  • Ability to function and communicate cross functionally and work with global groups.