Job Description

Company DescriptionDr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can\'t Wait.We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity - to strengthen our core further (the next steps) and to build the future (the new bets).\'The Next and the New\' is how we aim to continue to be the partner of choice - purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose - helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparencyDr Reddy's maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization."Purpose:PV is primarily responsible for the oversight of and provision of medical input to benefit-risk assessment activities including: ad hoc data analysis in support of internal/external queries; preparation and review of aggregate reports; signal detection and evaluation; support of benefit-risk evaluation efforts; generation and/or review of risk management plans (RMPs), risk evaluation and mitigation strategies (REMS), identification of risk minimisation measures; handling of responses to Regulatory Authority queries, scientific/medical input to other safety related documentation including Health Hazard Evaluations, clinical study protocols, final study reports, dossier documents, Medical Affairs activities, commercial/marketing information, as needed and providing support for product labelling activities.Main Responsibilities:

• Medical Review quality control (MRQC) of medical assessment of individual case safety reports (including coding, seriousness, expectedness, and company causality assessments) done by the vendor.
• Provide medical input and/or review of aggregate reports including: PSUR, PBRER, PADER, DSURs and ACOs.
• Conduct peer quality review of aggregate reports, and quality review of reports generated by the vendor.
• Signal management activities for assigned products, ensuring signal detection is conducted in a regular, timely manner in accordance with signal management schedule.
• Literature review for signal detection and validation.
• Signal validation report preparation.
• Conduct aggregate safety data review on an ad hoc basis to support benefit-risk evaluations.
• Author/review RMPs and aRMM activities as required
• Prepare/review Health Hazard Evaluations and other ad hoc safety reports as requested.
• Labeling document review: provide medical input to reference safety information, Investigator Brochures, product labels and patient information leaflets to ensure the most up to date and accurate safety information is present in all labeling information.
• Regulatory Authority query management: liaise with Regulatory Affairs to respond to PV-related Regulatory Authority queries; coordinate with various stakeholders when finalizing the response, ensure responses are tracked to closure.
• Participate in development of CAPA and take ownership of CAPA completion as assigned.
• Participate in regular, scheduled meetings with PV team/service provider/third parties as required.
• Support for PV QMS: Support the development and revision of department SOPs and work instructions. And participate in the review of cross-functional SOPs which include reference to PV activities.
• Any other activity assigned by Global Head- Medical Assessment.

Relationship Management

• Working within PV team and cross-functionally with key stakeholder functions including Clinical, Regulatory Affairs, Medical Affairs, Commercial Teams and Business Units.
• Interactions with vendors/service providers for PV activities.

Process Improvement / Standardization

• Participate in process improvement initiatives under supervision of Head of Medical Assessment and Global Head of Pharmacovigilance to promote internal audit and regulatory inspection readiness.

QualificationsEducational qualification: MBBS with or without MD0 to 3 years of relevant experience post MBBS or MDDesired Skills & Competencies

• Good working knowledge of PV regulations including FDA, EU & local requirements.
• Good data analysis and report writing skills.
• Excellent teamwork and interpersonal skills.

Dr. Reddy's Laboratories