PV Specialist - EUG Operations

Dr Reddy's Laboratories Limited; Hyderabad; On-site; INR 1,100,000 - 1,800,000; Full time

Job summary

Dr Reddy’s Laboratories Limited in Hyderabad seeks a Pharmacovigilance professional with 8+ years of experience to support EUG PV activities. You will coordinate EU/UK RMPs, perform safety variation tracking and PSUR-related tasks, ensuring timely data collection and quality control across the PV program.

You will interact with EU/UK PV teams and vendors, participate in process improvements, and support audits and CAPA as needed.

Qualifications

• B.Pharm/ M.Pharm with 8+ years of PV experience.
• Good knowledge of EU and UK PV regulations.
• Excellent teamwork and interpersonal skills.
• Good knowledge of MS Word, Excel and PowerPoint.

Responsibilities

• Under the supervision of the EU/UK QPPV, manage the EU RMPs and UK RMP trackers.
• Carry out SMPC updates and safety variation initiation and tracking.
• Handle RMP queries and Cmdh risk intimations.
• Collect PSUR data and perform QC.
• Collect and QC ACOs data.
• Maintain activity tracking spreadsheets for all PV activities.
• Handle EudraVigilance data and signal detection.
• Monitor PSR/PSUSA topics and plan next PSUR actions.
• Lead Post-authorization updates of RMPs and related variations with RA.
• Support deviations and CAPA processes.
• Support prior audits and inspections.
• Undertake any other duties assigned by the reporting manager.

Skills

EU/UK PV regulations

Teamwork

Time management

MS Office

Education

B.Pharm/ M.Pharm

Tools

MS Word

Excel

PowerPoint

Job description

• Job Family: Medical Affairs & Pharmacovigilance
• Sub Job Family: Pharmacovigilance
• Preferred type of working: On-Premise
• Years of Experience: 6 - 12
• Business unit: EUG

Company Description

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

This role is responsible to support the EUG PV activities while performing below mentioned activities.

Responsibilities:

• Under the supervision of the EU/UK QPPV, managing the EU RMP and UK RMPs and their trackers.
• SmPC updates and Safety variation initiation, tracking.
• 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 Support
• Prior Audit and inspection experience.
• Any other activities assigned by reporting Manager.

Relationship Management

• Working with EU or UK PV team, Global PV team.
• Interactions with vendor’s/service providers for PV activities
• Participate in process improvement initiatives under supervision of UK/EU QPPV.

Qualifications

Education: B.Pharm/ M.Pharm with 8+ years of experience.

• 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 Information

This role is a part of Pharmacovigiliance for EUG & will be based in Hyderabad location.