Unichem Labs Hiring Executive/Senior Executive – MPharma & BPharma Apply
Executive / Senior Executive – Medical Affairs
Mumbai, Maharashtra, India
About the job
Experience – 4 – 8 years
Qualification Requirement – B.Pharm / M. Pharm
Responsibilities
- Support and execute Pharmacovigilance-related activities in UNICHEM Laboratories Limited.
- Prepare and maintain Pharmacovigilance documentation and SOPs and training to the relevant stakeholders.
- Train the Pharmacovigilance team on standard operating procedures (SOP) and Work Instruction.
- Train the Pharmacovigilance team for conducting Pharmacovigilance training and related programs.
- Organize Pharmacovigilance training to corporate offices, manufacturing plants, distributors, and other vendors if applicable in a timely manner for new as well as existing UNICHEM employees.
- Assist the Pharmacovigilance team to execute all Pharmacovigilance-related activities.
- Prepare the periodic safety update reports (PSURs) and submit them to the regulatory authorities and risk management plans (RMPs) contribute to the Pharmacovigilance matrix to ensure that the Pharmacovigilance system is running in compliance with procedure and requirements.
- Coordinate with business partners for preparation and updating of SDEA agreements.
- Prepare and review Pharmacovigilance-related documents such as PSURs, PBRER, RMPs, PADER, SmPC, package inserts, and submission to regulatory agencies.
- Provide a satisfactory response to all medical information and Pharmacovigilance-related queries.
- Communicate with vendors in case of discrepancies.
- Train QPPV on SOPs and Pharmacovigilance.
- Submit individual case safety reports to regulatory authorities.
- Support the Medical Affairs team to respond to inquiries from Pharmacovigilance sources.
- Timely submission of PADERs and process invoices in the SAP system for payment release.
- Support in the selection, audit, oversight, and conduct of regular meetings with service providers (vendors and CROs) for Pharmacovigilance activities.
- Ensure that all Pharmacovigilance activities are conducted in accordance with UNICHEM SOPs and regulatory requirements.
Desired Skills and Competencies
- Good Pharmacovigilance knowledge
- Database Management, Presentation Skills
- Excellent Communication (Oral + Written)
- Passionate & Energetic
- Analytical & Operational
- Good with technology
- Teamwork, Team player
If you are interested in this position, please apply through the original notification.
