Key Responsibilities

- Act as the Pharmacovigilance Responsible Person (PVRP) on behalf of the organization.

- Be responsible for the organization's overall global Pharmacovigilance activities, including but not limited to the European Union (EU), the United Kingdom (UK), the United States (USA), Middle East and North Africa (MENA), Latin America (LATAM), China, and other international markets.

- Ensure timely communication with the Pharmacovigilance Service Provider (PSP), distributors, in-licensing partners, and regulatory authorities regarding Pharmacovigilance matters.

- Handle all incoming safety-related information received by the organization, ensuring appropriate forwarding to the PSP, in-licensing partners, and/or distributors.

- Log Adverse Events (AEs)/Adverse Drug Reactions (ADRs) in the Information Request Management System (IRMS).

- Perform monthly reconciliation of Pharmacovigilance documentation with the PSP, distributors, in-licensing partners, manufacturers, and relevant internal departments.

- Review and oversee documents prepared by the PSP, including:

- Signal Detection Reports

- Pharmacovigilance System Master File (PSMF) updates

- Company Core Safety Information (CCSI)

- Risk Management Plans (RMPs)

- Periodic Safety Update Reports (PSURs) and Periodic Adverse Drug Experience Reports (PADERs)

- Monitor compliance metrics and timely regulatory submissions, and manage deviations and CAPA actions in case of non-compliance from the organization's side.

- Prepare Quality Management Review summaries related to Pharmacovigilance compliance data.





- Support the screening and selection of recent Pharmacovigilance vendors in collaboration with internal stakeholders for applicable territories.

- Draft Pharmacovigilance-related agreements, including but not limited to Safety Data Exchange Agreements (SDEAs).

- Perform risk assessments of Pharmacovigilance partners.

- Track product labeling updates shared with the PSP.

- Implement and distribute Risk Minimization Activities.

- Develop and maintain the Annual Pharmacovigilance Training Plan and Pharmacovigilance Business Continuity Plan.

- Participate in safety communications involving senior management and regulatory authorities.

- Create and maintain the approved Pharmacovigilance vendor list.

- Prepare, review, and maintain Pharmacovigilance Standard Operating Procedures (SOPs) in accordance with current regulations, the organization's scope of work, and applicable territories.

- Participate in the preparation of Module 1 regulatory documents related to Pharmacovigilance.

- Manage the lifecycle of Pharmacovigilance documents within electronic document management systems (MyProcess).

- Participate as a Subject Matter Expert (SME) in Pharmacovigilance audits alongside the Lead Auditor and review audit reports.

- Provide support to Medical Information by responding to medical inquiries, based on expertise and qualifications.

- Perform all activities in compliance with applicable legislation, regulatory guidelines, company policies, and standard operating procedures.

- Demonstrate the organization's behavioral values and professional standards at all times.

📌 Senior Pharmacovigilance Specialist I (Bengaluru)
🏢 European pharmaceutical
📍 Bengaluru