Pharmacovigilance Specialist Job Opportunity at Dr. Reddy’s Laboratories Hyderabad

Purpose:

The PV Specialist is responsible to have oversight and management of SDEAs/PVAs for Business relationships in all regions. This includes coordination with various stakeholders, business relationship assessment, SDEAs/PVAs drafting, review & revision for Dr Reddy’s business relationships ensuring to meet the standard process and applicable regulatory requirements.

Responsibilities:

Regulatory & Compliance

• Update local and core Pharmacovigilance System Master Files (PSMFs)
• Ensure timely and accurate execution of Safety Data Exchange Agreements (SDEAs)
• Maintain activity tracking spreadsheets for PV operations
• Monitor and update Risk Management Plans (RMPs) post-authorization
• Handle Eudravigilance database activities and signal detection
• Ensure timely submissions of aggregate reports (PSURs/PSUSAs)
• Address regulatory intelligence, audits, and CAPA implementation

Communication & Collaboration

• Coordinate with regional and global PV teams
• Liaise with third-party vendors for pharmacovigilance tasks

Process Improvement

• Participate in process enhancements and standardization initiatives

Pharmacovigilance Specialist Job Opportunity at Dr. Reddy’s Laboratories HyderabadRelationship Management

• Build relationship with key stakeholders – Regional PV Leads, Business Units and legal as applicable.
• Define practices under the supervision and support of Global PV Head and Head of PV Operations to implement the same.

Process Improvement / Standardization

• Ensure PVA templates keep pace with changes in legislation
• Identify areas of process improvement and propose recommendations
• Support process automation for PVA management, including establishing database reporting rules for distribution of ICSRs to partners
• Resolve issues related to PVAs with teams.

Desired Skills & Competencies

• Knowledge of global regulations including FDA, EU & emerging market guidelines.
• Understanding of PV operations to ensure appropriate negotiation of terms in all PVAs
• Demonstrate understanding of commercial agreements with a view to matching the required PV strategy to the commercial relationship
• Previous experience in PVA management
• Excellent teamwork and interpersonal skills
• Excellent time management and organisational skills