Job Title: Safety Physician
Location: Bangalore, India
Company: Teva Pharmaceuticals
Job ID: 59384
Date: Nov 21, 2024
About Teva Pharmaceuticals
Teva is on a mission to make good health more affordable and accessible globally, helping millions of people lead healthier lives. As the world’s leading manufacturer of generic medicines, Teva produces many products featured on the World Health Organization’s Essential Medicines List. Today, 200 million people rely on our medicines daily. We are constantly seeking new ways to make a positive difference, and we invite individuals passionate about this mission to join us.
The Opportunity
The Safety Physician leads the safety profile for assigned medicinal products, guiding their safety through various stages of the product lifecycle. Working in partnership with Teva stakeholders, the Safety Physician assesses, defines, and mitigates risks associated with Teva’s drugs, ensuring a favorable benefit-risk ratio. They also provide essential safety information to regulators, prescribers, and patients.
Key Responsibilities
As a Safety Physician, you will:
Lead Safety Activities: Manage the safety profile of assigned products, including company-sponsored studies, compassionate use programs, and disease monitoring.
Cross-functional Leadership: Chair and lead the Product Safety Group, presenting findings to senior safety governance committees.
Medical Evaluation: Perform medical evaluation of safety data, including signal detection, dose escalation evaluations, and regulatory safety reports (PSUR, PADER, DSUR).
Signal Management: Oversee signal detection and validation activities, assess causality, and review safety data from multiple sources.
Risk Management: Lead risk management activities, contribute to the development of Risk Management Plans (RMPs), and define key risks throughout the product lifecycle.
Safety Contributions to Submissions: Contribute safety data for Health Authority submissions and respond to Health Authority requests.
Collaboration: Work closely with internal and external stakeholders (Medical Affairs, Clinical Development, KOLs, CROs) to represent Pharmacovigilance (PV) on safety concerns.
Training & Mentorship: Guide and train junior safety physicians and scientists in medical review, signal detection, and risk evaluation activities.
Due Diligence: Represent safety during due diligence processes for new products.
Qualifications & Experience
Education:
MBBS/MD degree or equivalent. Clinical practice experience and/or an epidemiological degree/training is a plus.
Experience:
4-5 years of experience in Pharmacovigilance, including ICSR/medical review and signal detection.
Knowledge of FDA and EMA regulations (GVP, GCP).
Registered with the Medical Council (MCI or state council).
Skills:
Analytical Skills: Evaluate safety data from various sources and assess clinical importance.
Cross-Functional Collaboration: Ability to work with global teams across time zones.
Communication Skills: Strong written and oral communication, able to present complex information clearly.
Problem-Solving: Ability to solve challenges creatively and practically in the workplace.
Social Intelligence: Understanding group dynamics and resolving potential conflicts effectively.
Interpersonal Skills: Collaborate well with stakeholders at various levels.
Why Teva?
Global Impact: Work with a company that serves 200 million people globally.
Professional Development: Be a key player in shaping the safety strategy for Teva's products across their lifecycle.
Inclusive Culture: Join a diverse and inclusive team that values collaboration and innovation.
Teva Pharmaceuticals is an Equal Opportunity Employer, and we are committed to diversity and inclusion. If you require accommodations throughout the recruitment process, please let us know, and we will provide support to ensure an accessible candidate experience.
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