Teva Pharmaceuticals USA, Inc.

Associate Director/Director Pharmacovigilance Physician

US-PA-Horsham
Requisition #
17-20011
# Positions
1
Category
Pharmacovigilance

Overview

 

Overview

Our work here at Teva builds upon the inherent strength of Teva’s unique makeup. We are integrating the best of our discovery research, our innate knowledge from our specialty portfolios and generics (including both small molecules and biologics), our delivery system abilities and other advanced technologies. Our focused TA areas include Respiratory, CNS and Neurodegenerative Disorders.  We have created a broad and varied pipeline that aims to address key unmet patient and societal needs.  We have an exciting career opportunity currently available for Associate Director/Director Pharmacovigilance located at our office in Horsham, Pennsylvania.

 

 

 

 

 

 

 

 

 

 

Responsibilities

 

Responsibilities

 

The Pharmacovigilance Physician is responsible for all safety and risk management of assigned Teva products across our Therapeutic Areas. It includes appropriate assessment of benefit risk information, medical evaluation of Individual Case Safety Reports (ICSR), aggregate reports, evaluation of safety signals, formulation of response to regulatory inquiries on product safety issues and contribution to regulatory documents which include:

 

Medical review of ICSRs for all products;

Accountable for medical evaluation/interpretation of aggregate safety data of products assigned including signal detection and evaluation, regulatory safety reports (PSUR, PADER, AERS data), and ad hoc safety review/assessments.

Leading safety management for clinical development programs assigned; leading the safety strategy via the Product Safety Group for each branded/innovative product; participating in relevant safety board or DSMB; contributing to study regulatory documents (e.g. protocol, IB, informed consent, clinical study report, as relevant to Pharmacovigilance and lead the strategy for the integrated summary of safety strategy

Participation of Global Pharmacovigilance activities such as Medical Scientific Group; supporting PhV operations

Contributing to the development of Risk Management Plans, REMS programs, as well as management of these plans

Participation in label review and revision; supporting Legal Department in safety related issues

Other duties as assigned or as business needs require.

In addition to the above, the Senior Safety Physician will be responsible for key brands that are important for Teva’s success. They may also lead key initiatives to improve safety efficiency or quality, as well as cross functional working, and are looked to as experts in safety or other key relevant disciplines.

 

 

Qualifications

Requirements:

 

MD degree.  Epidemiology degree or training a plus.

Board eligible/certified or equivalent residency or subspecialty training

Demonstrated track record of accomplishments in Pharmacovigilance

 

Years of Experience Required:

For Director: 5+ years Pharmacovigilance Industry experience required.

For Associate Director: 1 – 2+ years pharmacovigilance Industry or related Industry experience

1+ years clinical practice experience

Working knowledge of clinical development strategies as regards to experience in Drug Development, Risk Management Plans, REMS programs, Clinical Trials, Submissions Activities and Epidemiology).

Proven track record of leading projects

Must speak fluid English and be a proficient scientific writer

May lead a team of less experienced personnel

 

Specialized Technical Knowledge

ICH, EU GVP, FDA regulations pertaining to Drug Safety

Knowledge of global regulations and guidelines for drug development

 

Functional Knowledge

Good communication skills, analytical capability, writing; Fluent spoken and written English, assertiveness, teamwork skills, ability to work under pressure in a stressful environment, basic computer skills

 

Competencies:

Sound Knowledge of general medicine and clinical practice

Medical training and/or medical practice experience

 

Demonstrated knowledge of Drug Safety

Familiar with regulations and working experiences in pharmaceutical industry

 

Analytical Capabilities

Strong track record of scientific, strategic and analytic thinking

 

Leadership

Excellent communication skills, strong experience in leading teams in a matrix environment

 

 

 

 

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