Accountable for ensuring provision of project management expertise & support to the Global Patient Safety organization in the context of key safety document coordination including planning, quality review & distribution as well as other safety operational activities. In addition, building & driving safety project management team in Bangalore, India with the strong focus on Periodic Safety Reports & Risk Management Plans activities.This includes, but is not limited to the following tasks:Building, driving & maintaining the team of Safety Project Managers & PV Process Managers in Blore, India• Support integrity and development of the team, as a part of the Global Project Management & Periodic Safety Reports Team• Support process owner for the cross-functional processes for generation of Periodic Safety Reports (PBRER/PSUR, ACO, DSUR, pSUSAR reports) & Risk Management Plans (RMP)• Support design, implementation & continual improvement of the related processes & tools & their documentation as well as the definition & monitoring of key performance & quality indicators• Profound Project Management of all Merck Pharmacovigilance activities include but not limited to:Lead Activity Planning, Defining Scope, Developing Schedules & Time Estimations;Planning, support for preparation & management of meetings related to key safety activities such as safety data review/monitoring meetings, kick-off meetings with external partners;Support for management including tracking of various pharmacovigilance activities;Managing Risks & Issues, Risk Analysis;Development & conduct of PV training;Monitoring & Reporting Progress;• Support development & maintenance of the GPS Master Schedule Planner• Supports the maintenance of the PSR and RMP data & modules within the PV IT Tool (Orbit)• Support in overseeing compliance, such as deviation and CAPA activities, preparation of metrics & analysis of KPIs, Audits & Inspections, as required

Managed Project Lead and overall responsible for offshore Periodic Safety Reports deliverables with desired quality and timelines as per the contract.

Manage a team of 30 highly skilled associates involved in creation and submission of various Periodic Safety Reports like Periodic Benefit Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR), Addendum to Clinical Overview (ACO). Apart from reports, the team was also involved in creation and submission of line listings like PSLLs, PSUR Style LLs and PBRER ST & BR.

Involved in creation and submission of various Periodic Safety Reports like Periodic Benefit Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR), Addendum to Clinical Overview (ACO). Apart from reports, I was also involved in creation and submission of line listings like PSLLs, PSUR Style LLs and PBRER ST & BR.

Aggregate Reporting (Pharmacovigilance Med Writing)

involved in writing postmarketing documents like PSURs, ASRs, SMRs, SBRs, etc.

involved in writing postmarketing documents like PSURs, ASRs, SMRs, SBRs, etc.

Review and Quality check of clinical study documents like CSRS, IBS, Protocols, etc. Also review and quality check of publication documents like Posters, Manuscripts, Slidesets, Abstracts, etc.

Involved in transcription of patients from case reports.

Treated various dental patients.