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Pv Physician-Medical Assessment

5+ years
Not Disclosed
10 Aug. 21, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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 Description

Dr. Reddy’s Laboratories Ltd. is a leading global pharmaceutical company dedicated to accelerating access to affordable and innovative medicines. Founded in 1984 with just 20 employees, we now operate in 66 countries with a team of over 24,000 professionals. Our mission is guided by the principle that "Good Health Can’t Wait," and we strive to enhance access, affordability, and innovation in healthcare.

For nearly four decades, we have built our reputation on deep scientific expertise, progressive practices, and strong governance. As the pharmaceutical industry evolves, we are focused on strengthening our core capabilities while exploring new opportunities to drive growth. Our goal is to reach over 1.5 billion patients globally by 2030, with sustainability at the heart of our strategy. We are committed to operating in a way that respects people, the planet, and our purpose, ensuring that we conserve resources, create value, and maintain transparency and integrity.

At Dr. Reddy’s, we pride ourselves on fostering an inclusive work environment. We are an equal opportunity employer, dedicated to hiring and nurturing a diverse workforce, free from discrimination. We value every talent and recognize merit and diversity throughout our organization.

Job Title: PV Physician

Purpose

The PV Physician oversees and provides medical input for benefit-risk assessment activities. This includes ad hoc data analysis, preparation and review of aggregate reports, signal detection, risk management planning, and handling regulatory queries. The role also involves contributing to safety-related documentation, clinical study protocols, and product labelling.

Main Responsibilities

  • Medical Review and Quality Control: Oversee the quality control of medical assessments for individual case safety reports, including coding and causality assessments done by vendors.
  • Report Management: Schedule and ensure timely documentation of aggregate reports, Risk Management Plans (RMPs), and other safety-related documents.
  • Medical Input: Review and provide input on aggregate reports (e.g., PSUR, PBRER), signal management activities, and risk evaluation documents.
  • Signal Management: Validate and evaluate potential safety signals, summarize findings, and present to key stakeholders.
  • Regulatory and Clinical Support: Provide medical input for clinical study protocols, Health Hazard Evaluations, and product labelling. Handle responses to regulatory queries and support product acquisitions/divestments.
  • Process Improvement: Participate in process improvement initiatives, safety database upgrades, and support the development and revision of SOPs.
  • Training and Compliance: Support PV team training and act as a Subject Matter Expert during audits and regulatory inspections.

Qualifications

  • Education: MBBS, preferably with an MD.
  • Experience: At least 5 years of relevant pharmacovigilance experience post-MBBS.

Desired Skills & Competencies

  • Regulatory Knowledge: Good understanding of PV regulations, including FDA, EU, and local requirements.
  • Analytical Skills: Strong data analysis and report writing capabilities.
  • Interpersonal Skills: Excellent teamwork, problem-solving, and decision-making skills.

Additional Information

About the Department: The Finance function at Dr. Reddy’s plays a strategic role, extending beyond traditional accounting to include business partnering and digital transformation. This function supports various departments and includes multiple Centers of Excellence, covering areas such as treasury, risk, taxation, and corporate analytics.

Benefits Offered: Dr. Reddy’s offers competitive benefits, including personalized learning programs, relocation support, family benefits (maternity and paternity), medical and life coverage, and opportunities for career growth.

Our Work Culture: At Dr. Reddy’s, our guiding principle is "Good Health Can’t Wait." We foster a culture of empathy and dynamism, believing that diverse skills and a shared purpose lead to transformative impact. For more details, visit our career website: Dr. Reddy’s Careers.