Highlights:

Skills:

Principal Medical Writer 06/2022 - current
Rosemont Pharmaceuticals, Leeds, Leeds United Kingdom
Industry: Pharmacovigilance and Drug Safety
Lead the Medical Writing team Review of periodic safety reports such as PBRER, Product Safety Report, PADER, and RMP and submission of documents as required Responsible for preparing responses for regulatory queries
Lead the Medical Writing team Review of periodic safety reports such as PBRER, Product Safety Report, PADER, and RMP and submission of documents as required Responsible for preparing responses for regulatory queries PSMF review and update Responsible for CAPA review and closure Responsible for representing team in audits and inspections Responsible for sharing process related updates with management on a periodic basis Manage the work load of the team Monitor team performance and implement quality improvement plans Provide resolution for queries raised by the team members Preparation, review, and execution of SOPs Mentor new employees and ensures training compliance of the team Co-ordinate and conduct team meetings and support in growth of team members in the organization--
Senior Manager-Pharmacovigilance 02/2022 - 12/2022
Apcer Life Sciences, Ahmedabad, Gujarat India
Industry: Pharmacovigilance
I was leading a team responsible for literature screening for nearly 40 clients.
Team handling and management of daily workload of the team Review of Literature articles Review of ANDA/NDA annual literature reports Project Management including timely delivery, participation in status meetings and provide project progress update to the stakeholders Monitor team performance and implement quality improvement plans Responsible for providing solutions to queries raised by the team members Liaise with other verticals to understand their expectations and achieve required outcomes as per defined timelines Maintain awareness of changes to/new regulations affecting PV activities Preparation, review, and execution of SOPs Mentor new employees and ensures training compliance of the team Co-ordinate and conduct team meetings and support in growth of team members in the organization--
Senior Manager 08/2013 - 01/2021
Norwich Clinical Services, , India
Industry: Pharmacovigilance
Lead team of staff performing Regulatory website screening, Literature screening, and compliance monitoring in PV activities in compliance with global PV requirements. Review of periodic reports such as PBRER, PADER, DSUR, and RMP
Lead team of staff performing Regulatory website screening, Literature screening, and compliance monitoring in PV activities in compliance with global PV requirements. Review of periodic reports such as PBRER, PADER, DSUR, and RMP Ensure effective and efficient resource utilization. Review and assessment of findings from weekly regulatory site search activities and proposing recommendations for client product labels. Responsible for legislation screening and impact analysis related to the update on PV guidelines. Provide recommendation of safety label update. Compliance tracking of ICSRs including the submission of cases to authorities. Guided the team and actively contributed in the preparation of CCSIs Compliance tracking for the ongoing safety issues and also provided recommendation to Clients on actions need to be taken on these issues. Data entry, review, and submission of XEVMPD filings. PSMF review and update Responsible for assessing and providing recommendations on safety concerns during the signal detection meetings. Training new recruits on guidelines, SOPs, and academic activities.--
Aggregate Reporting Scientist 04/2007 - 08/2013
Accenture Services Pvt. Ltd, Chennai, Tamil Nadu India
Industry: Pharmacovigilance
Authoring and review of aggregate safety reports such as PBRER, DSUR, PADER, RMP, SUSAR and Investigational SUSAR, ASR, SBR, Line-Listing, Addendum, Safety Summary, Russian renewal, and Clinical overview.
Authoring and review of aggregate safety reports such as PBRER, DSUR, PADER, RMP, SUSAR and Investigational SUSAR, ASR, SBR, Line-Listing, Addendum, Safety Summary, Russian renewal, and Clinical overview. Review standard line listings and determines, which cases need to be included in the Aggregate reports. Provided guidance and mentoring for new joiners and team members.--

Vels University 12/2009 - 01/2016
Chennai, Tamil Nadu, India
Degree: Doctoral Degree
Major:Biotechnology
I have been awarded doctorate in the year 2016

Jingle Pappachan-CV Pharmacovigilance