PV Specialist - EUG Operations

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.

Qualifications :

B.Pharm/ M.Pharm with 1012 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 Information :

About the Department
Global Manufacturing Organisation (GMO)
At Dr. Reddys 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 stateoftheart 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 1150 drug master files across key therapy areas such as Oncology Cardiovascular Central Nervous System and AntiDiabetes. 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. 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

Remote Work :

No

Employment Type :

Fulltime