Pharmacovigilance (PV) Specialist - ROW Market

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.

Purpose:

We are seeking a dedicated and detail-oriented PV Specialist to join our team. The associate will work under the guidance of respective Head of Pharmacovigilance of the assigned region and shall be responsible for managing various pharmacovigilance tasks. The ideal candidate will have excellent communication and organizational skills, as well as a strong understanding of regulatory requirements in ROW countries.

Responsibilities:

• Assist in updating both local and core PSMFs
• Collaborate with partners to create and update SDEAs with the latest consumer healthcare information under the supervision of the Head of Pharmacovigilance of ROW region.
• Ensure compliance with SDEA requirements, such as reconciliation of PV activities in ROW region.
• Keep activity tracking spreadsheets up-to-date to ensure all tasks are consistently monitored and recorded.
• Manage the Eudravigilance database and perform signal detection activities as required.
• Manage RMP queries and CMDh risk notifications.
• Update RMPs post-authorization and track related variations with RA.
• Ensure compliance for aggregate reports, including PSUSAs, for regulatory intelligence and tracking tasks to be addressed in the next PSUR, as well as establishing a close monitoring list.
• Manage deviations and CAPAs: Identify and report any deviations in procedures and participate in CAPA development, assuming responsibility for CAPA completion when assigned.
• Provide support during audit and inspection preparation, actively participate during audits, address any observations, and assist in CAPA closure
• Able to manage any assigned task of Pharmacovigilance on ad-hoc basis.

Relationship Management

• Working with other regional teams and central cross functional teams across the Globe.
• Interactions with vendor’s/service providers for PV activities.

Process Improvement / Standardization

• Participate in process improvement initiatives under supervision of Head of Pharmacovigilance of respective region.

Desired Skills & Competencies

• Bachelor's degree in pharmacy, Master’s degree is preferred.
• Minimum 8 years of experience in pharmacovigilance out of which at least 3 years in core pharmaceutical company.
• Strong understanding of regulatory requirements and guidelines of respective countries
• Excellent communication and organizational skills
• Proficiency in Microsoft Office, including Excel, PowerPoint
• Ability to work independently and as part of a team.
• Detail-oriented and able to manage multiple tasks simultaneously.

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. 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 ‘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 catalyse 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. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re 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