PV Specialist - EUG Market
PV Specialist - EUG Market
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Job Description
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 EUG and 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 respective region.
- Ensure compliance with SDEA requirements such as reconciliation of PV activities in respective 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 vendors/service providers for PV activities.
Process Improvement / Standardization
- Participate in process improvement initiatives under supervision of Head of Pharmacovigilance of respective region.
Qualifications :
Desired Skills & Competencies
- Bachelors degree in pharmacy Masters 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 EUG and ROW 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.
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 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 1150 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. 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 :
Full-time
Employment Type
Full-time
