Pv Specialist

4 weeks ago

Hyderabad, Telangana, India Dr. Reddy's Laboratories Full time

Company DescriptionDr Reddys 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 Cant 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 xe2x80x98The 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 Reddys 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 We are looking for candidates who are immediate joinees for this role Purpose This role is responsible to support the EUG PV activities while performing below mentioned activities Activities Under the supervision of the EU UK QPPV managing the EU RMP and UK RMPs Handling of RMP queries Cmdh intimation of risks PSUR data collection and QC ACOs data collection and QC Tracking and Documentation ensure all activities are tracked through the maintenance of activity tracking spreadsheets Eudravigilance database handling and Signal detection Regulatory Intelligence Monitor PSUSAs and track the activities to be addressed in next PSUR Post authorisation update of RMPs - initiation and its related variations tracking with RA Deviation CAPA management raise deviations to PV processes when identified Participate in development of CAPA and take ownership of CAPA completion where assigned Prior Audit and inspection experience Skills required Prior Pharmacovigilance experience with EU PV activities and team interactions Sound knowledge on RMP PSUR and other Aggregate reports Eudravigilance knowledge Knowledge on deviations and CAPA Previous experience with Audits and Inspections Relationship Management Working with EU or UK PV team Global PV team Interactions with vendors service providers for PV activities Process Improvement Standardization Participate in process improvement initiatives under supervision of UK EU QPPV QualificationsB Pharm M Pharm with 10-12 years of experience Desired Skills Competencies Good working knowledge of EU and UK PV regulations Performs timely coordination of safety information dissemination Excellent teamwork and interpersonal skills Excellent time management and organizational skills Good knowledge of computer applications and software including MS Word Excel PowerPoint etc Additional InformationAbout the Department Global Manufacturing Organisation GMO At Dr Reddy s Laboratories we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation With a legacy of excellence we are a leading force in the pharmaceutical industry We operate 19 state-of-the-art manufacturing plants across Hyderabad Vizag Baddi Mexico Shreveport and Mirfield comprising 8 OSD facilities 3 Injectables facilities and 8 API facilities Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries We manufacture a portfolio of complex APIs and 1 150 drug master files across key therapy areas such as Oncology Cardio-vascular Central Nervous System and Anti-Diabetes he World Economic Forum has recognised our largest manufacturing facility in Bachupally Hyderabad as part of its Global Lighthouse Network We aspire to be the most efficient pharma operations in the world Our productivity improvement and digitalisation efforts are key to staying competitive meeting business imperatives and meeting our ambitious ESG goals Building such xe2x80x98factories of the future is integral to innovation and to build healthcare of the future Benefits Offered At Dr Reddys we actively help to catalyse your career growth and professional development through personalised learning programs The benefits you will enjoy at Dr Reddys are on par with the best industry standards They include among other things and other essential equipment joining relocation support family support Maternity Paternity benefits learning and development opportunities medical coverage for yourself and your family life coverage for yourself Our Work Culture Ask any employee at Dr Reddys why they come to work every day and theyll say because Good Health Cant Wait This is our credo as well as the guiding principle behind all our actions We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit And to do this we foster a culture of empathy and dynamism People are at the core of our journey over the last few decades They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic For more details please visit our career website at https careers drreddys com

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