Shravan Akena

A multi-skilled professional seeking a challenging position within the Pharmaceutical industry where I can best utilize my acquired knowledge, and capitalize on challenging opportunities for advancement in the field of Pharmacovigilance.

An overall 12 years of Pharmacovigilance professional experience with strong technical skills to handle diverse global pharmacovigilance activities in Clinical Trials and Post Marketing phases of product lifecycle. Strong knowledge on Pharmacovigilance setup and can handle the global pharmacovigilance obligations of the diverse regulatory authorities with the aim of 100% quality and regulatory compliance and drive towards new levels of success and meeting business goals, in a highly competitive and fast-paced environment. Proficiency in Global Pharmacovigilance activities including ICSRs (end to end activities), PSMF (Preparation & maintenance), SDEAs (Preparation and maintenance), PADERs, PSURs/PBRERs/ACOs (preparation, review, eCTD compilation and submission), Signal Management, global RMPs (Expertise in drafting and review), Handling of queries from agencies (RFIs, PSUSA queries, RMP queries), Preparation of Standard Operating Procedures (SOPs). Actively participated in FDA inspection (GMP Audit; Product Quality Complaints; Spontaneous Reports from market; Pharmacovigilance) in Dec'16 at Hetero and five (5) days FDA inspection (Pharmacovigilance) in Jul'18 at Micro Labs Ltd.

• Procedural documents: Pharmacovigilance Setup with relevant Standard Operating Procedures (SOPs), Identification of new procedural requirements as per the regulatory updates, Drafting company Pharmacovigilance Guide, reporting procedures and Data Migration Plans
• Pharmacovigilance System Master File (PSMF): Preparation and maintenance of PSMF and communicating to Qualified Person Responsible for Pharmacovigilance (QPPV), Preparation and maintenance of Summary of Pharmacovigilance System (module 1.8.1 of the dossier), Preparation, maintenance and timely update of Annexes of the PSMF, Maintenance of PSMF log (change control details, date, person responsible for change and nature of change) in accordance with EU regulations., Preparation, maintenance and review of monthly compliance reports with QPPV and other Business partners., Preparation and supporting for Internal/External audits and preparation of audit reports and responses to observations
• Safety Data Exchange Agreements / Pharmacovigilance Technical Agreements (SDEAs/PVTAs): Preparation and review of SDEAs and other Pharmacovigilance Agreements based on master commercial agreement and/or license and supply agreement., Scheduling of safety meetings and initiating the audits with B-Partners, distributors and affiliates as per the SDEA and PVTA terms., Co-ordinating with business/license partners, QPPV and other regional PV leads for smooth execution of the SDEAs., Maintenance and timely update of SDEA log (contact lists, review cycle and Products covered), Actively participated in PV due diligence activities for MA transfers / product acquisitions etc., Ensure to have monthly reconciliation with partners on exchange of safety reports
• Aggregate reports (PSURs/PBRERs, ACOs, PADERs): Review the PSUSA and/or PRAC preliminary assessment reports and providing responses to the authority if necessary and reviewing the final assessment reports to track the points to be addressed in next PSURs., Quality Review of PBRERs/PSURs, ACOs and PADERs as per client SOPs and WIs, Preparation, compilation and submission of various aggregate reports including Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs) and other addendum reports for global regulatory with excellent and reliable quality., Perform analysis (causality assessment) and provides the safety discussion/conclusion for safety topics., Identify the line unit responsible/ contributors (Including Pharmacovigilance Alliance (PVA) representative/ Manager & License Partner (LP) (as required) and conduct the kick-off meetings all the stakeholders for required data to prepare periodic reports., Preparation of product sales data and calculate the average patient exposure and frequency., Schedule meetings with client Single Point of Contact (SPOC) to resolve report related queries., Generation of line listing and summery tabulations for all SAEs from ARGUS and ARISg data bases., Preparation of PSUR and PADER calendars and maintaining regulatory submission tracker and update them on timely manner.
• Safety Review Reports (Signal Management): Preparation and review of signal Detection and Risk Benefit analysis and communicating to QPPV, involve in signal review meetings with EU QPPV/NQPPV/Affiliates., Assist the Medical Safety Physicians in monitoring the safety profile of assigned products., Involve in safety monitoring activities like signal detection and alert the safety physician for potential safety signals based on incoming case reports.
• Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS): Preparation and review of global RMPs for EU as per GVP Module V (Rev 2) and ROW countries, Prepared RMPs for different legal basis like CP procedure, Article 10(a), 10(1), 10(3) and 10(c)., Performing the follow-up with complainants using targeted follow-up questionnaires prepared as a part of routine pharmacovigilance, Ensure all the risk minimization activities are being done as committed to Health Authorities, Knowledge and understanding the requirement of REMS and coordinated in a Single Shared System REMS. Participated in Opioid REMS.
• Individual Case Safety Reports (ICSRs): Triage, MedDRA coding of AEs, narrative writing and Quality Review of ICSRs, Regulatory submission of ICSRs via E2B (ESTRI gateway) to Health Authorities., Handling of Spontaneous reports (customer complaints/enquiries) from the market., Monitoring and management of ICSR work flow in Safety database.
• Other PV processes: Ensures to meet global Pharmacovigilance compliance and regulatory requirements, Response to Regulatory Queries, Hand on experience on Databases like Eudravigilance including EVWEB, Medical Literature Monitoring, EVDAS and eRMR, Art. 57 Database (XEVMPD), Training and Mentoring to PV personnel, local affiliates and other business partners., Mentor and train PV staff in own area of expertise e.g. signal evaluation methodology, risk management and/or preparation of safety reports and other documents., Ensure all the records and documents are maintained as per organizational requirements and defined procedures., Maintenance and reconciliation of Marketing Authorization/ product Approval status with Global Regulatory team., Quality Management