Job Title: PV Specialist – Safety Data Exchange Agreements (SDEA)

Location: Hyderabad, India
Job Type: Full-time
Department: Medical Affairs & Pharmacovigilance
Work Preference: On-site
Business Unit: Global Manufacturing Organisation (GMO)

Company Overview:

Dr. Reddy’s Laboratories Ltd. is a big global company that makes medicines. We have over 24,000 employees who work together to create affordable and innovative medicines. Our company started in 1984 with just 20 employees, and now we have research centers, manufacturing plants, and offices in 66 countries. 

Our goal is to help more than 1.5 billion patients by 2030 with our medicines. We believe in doing the right thing, taking care of people, and protecting the environment.

Job Description:

As a PV Specialist, you will manage and oversee Safety Data Exchange Agreements (SDEAs). You will make sure all agreements with our business partners meet safety and regulatory requirements. This role is very important to ensure that our medicines are safe for patients.

Key Responsibilities:

You will work with different teams to make sure all agreements include necessary safety obligations. You will keep all SDEAs current with the latest templates and legal requirements. You will help draft, review, and approve SDEAs to ensure they meet business and regulatory standards. 

You will lead discussions with business partners to finalize SDEAs. You will maintain a record of all agreements and ensure they are stored properly. You will regularly review and update SDEAs to ensure compliance. 

You will keep a master list of all active SDEAs and related agreements. You will make sure all SDEAs are followed correctly and monitor compliance. You will act as an expert during audits and inspections.

Relationship Management:

You will establish good working relationships with key stakeholders. This means you will communicate and work well with important people in the company and with our business partners. You will work under the guidance of senior management to define and implement best practices.

Process Improvement:

You will ensure PVA templates are up to date with the latest legal changes. You will look for ways to improve processes and suggest recommendations. You will help automate PVA management processes. This means making our processes more efficient and up-to-date.

Qualifications:

You should understand global regulations like FDA and EU guidelines. You should have experience in PV operations and PVA management. You should be able to work well with others and have good interpersonal skills. You should have excellent time management and organizational skills. This will help you manage your work efficiently and meet deadlines.

Equal Opportunity Employer:

At Dr. Reddy’s, we treat everyone equally and with respect. We do not discriminate based on race, religion, nationality, gender, age, disability, or any other characteristic. We support a diverse workforce and recognize everyone’s unique talents. We value and treasure every talent, ensuring that everyone has an equal chance to succeed.

About the Department:

The Global Manufacturing Organisation (GMO) at Dr. Reddy’s is dedicated to precise manufacturing and innovation. We have 19 advanced plants in locations like Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield. We produce a wide range of medicines, including complex Active Pharmaceutical Ingredients (APIs) and over 1,150 drug master files. Our facility in Hyderabad is recognized as part of the Global Lighthouse Network for its excellence. We aim to be the most efficient pharma operations in the world, focusing on productivity and digitalization. This means we use the latest technology and best practices to make high-quality medicines.

Benefits:

We offer personalized learning programs to help you grow in your career. Enjoy benefits like joining and relocation support, maternity and paternity benefits, and medical and life coverage for you and your family. These benefits are designed to support you and your family’s well-being.

Work Culture:

At Dr. Reddy’s, we believe in “Good Health Can’t Wait.” This motto guides all our actions and motivates our employees every day. We are committed to making a positive impact on global healthcare. Join us and be part of a team that is dedicated to making a difference!

Apply now to become a PV Specialist at Dr. Reddy’s Laboratories and help us make the world a healthier place! As a PV Specialist, you will play a crucial role in ensuring our medicines meet all safety and regulatory requirements. Join our team in Hyderabad as a PV Specialist and contribute to our mission of improving global health. Learn more about how pharmacovigilance interviews are conducted here and prepare with these interview questions.

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Hello! I'm Namrata K, a skilled writer with a strong background in clinical research, pharmacovigilance, and similar fields. I create clear and engaging content that is perfect for the healthcare industry. With my expertise, I can make your projects shine with precision and simplicity.

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  1. Pingback: Sanofi has an opening for a Senior Clinical Data Coordinator in Hyderabad. - Pharmajobsnow.com

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