Dr. Reddy’s Laboratories Ltd. is an Indian multinational pharmaceutical company based in Hyderabad. The company was founded by Kallam Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited.
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JOB DESCRIPTION:
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
- Job Location: Hyderabad
Vacancy details:
- Department: Pharmacovigilance (PV) Specialist – ROW Market
- Qualification: Bachelor’s degree in pharmacy, Master’s degree is preferred.
- Minimum work experience: Minimum 8 years of experience in pharmacovigilance out of which at least 3 years in core pharmaceutical company.
QUALIFICATIONS:
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.
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.
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