Senior Drug Safety Specialist (Sr DSS)

Primary Responsibilities
Department/Function Pharmacovigilance (PV)

• Sr DSS is primarily responsible for the overall planning, co-ordination and delivery of pharmacovigilance services to customers.
• Oversee and may perform day-to-day Pharmacovigilance (PVG) activities within a highly regulated environment and driven by stringent timelines.
• Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information.
• Effectively collaborates with various parties such as: project teaUpgrade to see actual infombers, customers and third-party stake holders.
• Exercises independent judgment to troubleshoot and resolve project issues and to identify areas for improvement.
• Mentor new joiners and provide refreshers to the team.
• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices and procedures.
• Maintains medical understanding of applicable therapeutic area and disease states.
• Participates in/lead departmental initiatives; Serves as a subject matter expert in designated area.
• Ensure compliance is met to Regulatory bodies, affiliates and partners in the stipulated timelines.
• Monitoring of the company sponsored digital media as per the Standard Operating Procedures (SOPs).
• Act as case owner for assigned Individual Case Safety Reports (ICSRs) to ensure accurate completion of data entry (DE), Quality review (QR) and regulatory reporting, in line with SOPs and legislations.
• Ensure conduct of timely literature searches according to appropriate regulations and SOPs for purpose of ICSR identification and other safety information.
• Ensure quality review performed and appropriate attempts of follow-ups to library for full text, author or publisher/translating agency and affiliates.
• To ensure the adequate support is met during Audits and inspections.
• Handling deviations and Corrective Action and Preventive Action (CAPA) management.
• Ensure up to date all the relevant trackers and /or formats.
• Maintain a high standard of case quality.
• Assisting with reconciliation of all adverse event reports received from customers and its affiliates.
• Management and prioritization of individual workload while maintaining good documentation practices (GDP).
• Handling and management of Eudravigilance and health authority reports.
• Contribute to the development of SOPs and PV training including updates and implementations.
• Highlighting any safety related issues to the attention of the management team.
• All other ad hoc PV activities as required by the business needs.
• Keep abreast of changes to PV Legislation.
• Adhere to agreed Key Performance Indicators (KPIs).
• Handling, reconciliation and management of safety data exchange agreements (SDEA)/Pharmacovigilance agreements.
• Author, update and review the Pharmacovigilance system master file (PSMF) and its annexures as per the regulatory requirements.
• Compliance to be monitored as per SOPs.
• To support in the preparation of presentations and extracting line listings and delivering per business needs.

Additional Responsibilities:

• Responsible for authoring and review of Aggregate Reports like PADERs, PSURs, PBRERs, DSURs, CARs.
• Maintenance of timely schedule for the aggregate report trackers including work allocation within the team and quality check.
• Authoring and management of safety signal activities including Literature searches, line listing generation and analysis and responsible for regulatory intelligence.
• Co-ordination and management of signal management meetings.
• Support in authoring and review of Risk Management Plans (RMP) and other related activities as and when required.
• Support in preparation and updating product labels and Company core data sheets (CCDS).

How to Apply:

Interested candidates should submit their resume and a cover letter detailing their relevant experience and qualifications to Upgrade to see actual info with the subject line "Sr. DSS VA". PLEASE ATTACH THE LINK OR SHORT VIDEO INTRODUCTION OF YOURSELF HIGHLIGHTING YOUR EXPERTISE AND EXPERIENCE AS A VIRTUAL Sr. DSS.