PV Specialist-ICSR Operations Job at Hyderabad, Telangana, India Full Time

Dr. 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 transparency

Dr 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.

Job Description

Purpose: The “PV Specialist – ICSR Operations” is responsible for the support of PV Operations activities including but not limited to: safety case report handling activities, primarily performing sponsor quality check of global ICSRs; maintenance of Global Country Product List, Products labels and contributing as point person for providing functional business user requirements for development of Global Product Library and other process innovation platforms as per regulatory requirements and internal DRL standards.

Roles & Responsibilities:

• Performing the role of sponsor quality check of ICSRs on sample of cases, processed by the case processing vendor on daily basis.
• Answering all case related queries pertaining to quality findings received from Case Processing vendor.
• Liaising with EM affiliates for newly approved products and maintaining the product list and also for other PV activities
• Maintenance and ensuring availability of the latest Reference Safety Information documents/ PILs of approved products for Labelling assessment.
• Liaising with cross functional teams of DRL such as Regulatory affairs, marketing/sales, Business development team, Finance team, Medical Affairs, and other team for compilation of required data for pharmacovigilance activities.
• Provide sponsor quality analysis report for internal compliance meetings, monthly report and for inclusion in the PSMF as required
• Support during Audit & Inspection: Act as SME for AE handling activities during audit and regulatory authority inspections, as needed. Perform other ad hoc, PV related activities as requested by management.

Qualifications

M Pharm with 10-12 yrs of experience in PV/ICSR.

• Experience of performing quality check of ISCRs processed and strong knowledge of all cases processing and submission conventions.
• Good working knowledge of PV regulations including FDA, EU & local requirements.
• Performs timely coordination of safety information dissemination with minimal direct supervision
• Excellent teamwork and interpersonal skills
• Excellent time management and organisational skills
• Good knowledge of computer applications and software, including MS Word, Excel, PowerPoint etc.

Additional Information

About 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. The 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 ‘factories of the future’ is integral to innovation and to build healthcare of the future.

” Benefits Offered

At Dr. Reddy’s we actively help to catalyze your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddy’s 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. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions…

For more details, please visit our career website at https://careers.drreddys.com/