Https://Careers.Teva/Job/Bangalore-Sr-Mgr-Phv-Safety-Physician-Indi-560064/1235323900/

4-5 years

Not Disclosed

Bangalore

10 Dec. 27, 2024

Job Description

Job Type: Full Time Education: MBBS/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Safety Physician
Company: Teva Pharmaceuticals

Mission:
Teva Pharmaceuticals is dedicated to making good health more affordable and accessible to millions around the world. As the world’s leading manufacturer of generic medicines, Teva aims to improve the lives of at least 200 million people globally who take one of Teva’s medicines every day. We focus on delivering innovative solutions and continue striving to make a positive difference in healthcare.

The Opportunity:
As a Safety Physician, you will lead the safety profile of Teva’s medicinal products throughout their lifecycle, ensuring that safety risks are monitored, minimized, or mitigated. This role requires you to assess the benefit-risk ratio of Teva’s products, contributing to safety governance across the company. You will provide comprehensive safety information to regulatory agencies, healthcare providers, and patients, ensuring a positive benefit-risk profile.

Key Responsibilities:

Lead activities to determine the safety profile of assigned products, including the characterization, monitoring, and mitigation of risks.
Chair the cross-functional Product Safety Group and present decisions to senior safety governance committees.
Accountable for medical evaluation and interpretation of aggregate safety data, including signal detection, dose escalation evaluations, and regulatory safety reports (PSUR, PADER, DSUR).
Perform signal management activities, including signal validation and causality assessment.
Lead risk management activities globally, contributing to the preparation of Risk Management Plans (RMPs), REMS, and other risk minimization strategies.
Represent Pharmacovigilance (PV) in cross-functional teams, collaborating with teams from Medical Affairs, Clinical Development, Quality, and external partners (CROs, KOLs).
Guide and train other safety physicians and scientists in safety surveillance activities, such as medical review, signal detection, and risk evaluation.
Represent safety during product due diligence and other safety-related evaluations.

Qualifications and Experience:

Education: MBBS/MD degree or equivalent, with clinical practice experience and/or epidemiological training preferred.
Experience: Minimum 4–5 years of experience in pharmacovigilance, including ICSR/medical review and signal detection.
Regulatory Knowledge: Strong understanding of FDA and EMA regulations (GVP, GCP).
Skills:
- Analytical skills to critically evaluate safety data and assess the benefit-risk ratio.
- Ability to collaborate cross-functionally with an international team across multiple time zones.
- Strong interpersonal, communication, and negotiation skills.
- Social intelligence and the ability to manage group dynamics within cross-functional teams.
- Results-driven with a patient-centric approach.
- Problem-solving skills to address challenges and provide solutions.

Job-Specific Competencies:

Analytical Skills: Ability to evaluate safety data from various sources, assess clinical importance, and clearly communicate findings.
Results and Performance-Driven: Ownership of outcomes with a focus on patients' benefit-risk assessment.
Interpersonal Skills: Strong relationship-building with stakeholders at all levels.
Communication Skills: Effective written and verbal communication, with the ability to influence and negotiate with stakeholders.
Problem-Solving: Creativity and experience in finding solutions to challenges that arise in the workplace.

Reports To:
Director, Pharmacovigilance

Teva’s Equal Employment Opportunity Commitment:
Teva is committed to providing equal employment opportunities to all candidates without regard to race, religion, sex, disability, or any other legally protected status. We value diversity and inclusion, and we strive to create a welcoming and supportive environment for all employees. If you require accommodations during the recruitment process, please let us know.

Join Teva in making a difference in healthcare worldwide!

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Https://Careers.Teva/Job/Bangalore-Sr-Mgr-Phv-Safety-Physician-Indi-560064/1235323900/

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