Pv Physician-Medical Assessment

5+ years

Not Disclosed

Hyderabad

10 Aug. 14, 2024

Job Description

Job Type: Full Time Education: MBBS 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

Company Overview

Dr. Reddy’s Laboratories Ltd. is a globally recognized multinational pharmaceutical company, with a presence spanning across 66 countries and over 24,000 employees. Our collective mission is simple yet profound: to accelerate access to affordable and innovative medicines, because Good Health Can’t Wait.

Founded in 1984 with just 20 employees and a bold vision, we have grown into a leading name in the pharmaceutical industry. Our journey over nearly four decades has been grounded in a commitment to accessibility, affordability, and innovation, all built on a foundation of deep scientific expertise, forward-thinking people practices, and robust corporate governance. As the pharmaceutical landscape evolves, we see tremendous opportunity in both fortifying our core strengths and pioneering new innovations.

At Dr. Reddy’s, our strategy, known as ‘The Next and the New,’ reflects our dedication to being a purpose-driven, future-ready, and sustainable partner of choice. By 2030, we aim to impact over 1.5 billion patients worldwide, leveraging our core business growth while embracing sustainability as a central tenet of our purpose. Sustainability for us means respecting people, the planet, and our purpose, allowing us to conserve resources, deliver value to stakeholders, and uphold our integrity.

We foster a work environment free from discrimination and are proud to be an equal-opportunity employer. Our commitment to diversity and inclusion is unwavering, as we embrace the talents of all qualified individuals, regardless of race, color, religion, nationality, gender, age, disability, or any other protected characteristic. We value merit and diversity and believe that every talent within our organization contributes to our collective success.

Job Description

Position: PV Physician

Purpose:
The PV (Pharmacovigilance) Physician is responsible for providing medical input into various benefit-risk assessment activities. This includes analyzing data for internal and external queries, reviewing aggregate reports, conducting signal detection and evaluation, and supporting the development of risk management plans (RMPs) and risk minimization strategies (REMS). The PV Physician will also be involved in responding to regulatory authority queries and providing medical input to safety-related documentation.

Key Responsibilities:

Oversee and provide medical input to benefit-risk assessments, including aggregate report preparation, signal detection, and risk management plan development.
Conduct quality control of medical assessments for individual case safety reports.
Provide medical input and review for aggregate reports, ensuring regulatory compliance.
Engage in signal management activities, including signal detection, evaluation, and reporting.
Collaborate with PV Scientists to ensure accurate and timely preparation of safety reports.
Contribute to the identification, design, and implementation of additional risk minimization measures.
Provide medical input for clinical and regulatory activities, including study protocols, safety information, and labeling document review.
Manage regulatory authority queries related to PV, coordinating with stakeholders to finalize responses.
Participate in due diligence for product acquisitions/divestments and in process improvement initiatives.

Qualifications:

Education: MBBS, preferably with an MD.
Experience: At least 5 years of relevant PV experience post-MBBS.
Skills: In-depth knowledge of PV regulations (FDA, EU, local), strong data analysis and report writing skills, excellent teamwork, interpersonal, problem-solving, and decision-making abilities.

Additional Information:

About the Department:
The Finance function at Dr. Reddy's is integral to our strategic decision-making, extending beyond traditional responsibilities to act as a strategic partner across departments. Currently undergoing a digital transformation, our finance teams are aligned with various business units and operate through multiple Centers of Excellence, covering treasury, risk management, taxation, analytics, and global reporting.

Benefits:
Dr. Reddy’s offers industry-leading benefits, including personalized learning programs, relocation support, family support (maternity and paternity benefits), medical coverage for you and your family, life insurance, and more. We are committed to catalyzing your career growth and professional development.

Work Culture:
At Dr. Reddy’s, our work is driven by the belief that Good Health Can’t Wait. We see healthcare as not just scientific formulation but as a means to help people lead healthier lives. Our culture is one of empathy and dynamism, where individual abilities are nurtured within a collaborative environment. We believe that when people with diverse skills unite under a common purpose and value system, they can achieve extraordinary results.

For more information, please visit our careers website at Dr. Reddy’s Careers.

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Pv Physician-Medical Assessment

Job Description

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