Royal college of pharmacy and health sciences, Berhampur, Orissa

Lal Bahadur Shastri College of Pharmacy

Assistant Manager at 3R Pharma Consulting GmbH

Project Manager:
Working as a Project Manager at Vigilare Biopharma Hyderabad.

Own end-to-end project/program delivery, including Scoping, Prioritizing, Project plan, schedule, execution/monitoring working with Cross-functional teams globally.

Direct and manage Projects with cross functional teams spread globally, playing a leadership role in development, implementation and launch process across products.

Identify project risks, control them and manage regular communication to stakeholders, ensuring thoroughness in dealing with the details.

Under this capacity managing Aggregate reports project for 5+ clients from different regions, Escalation management, Resource management, Project Billing, Compliance etc.

Responsibilities:
Project coordination throughout the project life cycle.
Project management documents such as the project plan, budget, or schedule as needed.
Monitoring of project progress and create project status reports for management and stakeholders (e.g., accomplishments, next steps, issues, risks, action items, interdependencies, etc.)
Facilitate meetings and workshops between the project team and stakeholders as required. Contribute to meeting minutes.
Assist with resource scheduling
Support project team members when implementing risk management strategies.
Track progress of issues resolution and risks mitigations as per the agreed plans.
Help develop communication materials as required (change management, communications, trainings, etc.)
Track project team resources, project financials and contract as necessary.

Vigilare Biopharma Pvt Ltd

Project Manager Aggregate Reports

Manager:
Working as a Manager at Vigilare Biopharma Hyderabad.
Under this capacity managing a 7 teams (3 ICSR Teams), Aggregate Team, MR Team, Mailbox handling Team, Follow up Team.
Client communications
Recruitment of new hires

Individual contributor:
As a individual contributor review of aggregate reports viz. PSUR, PBRER, PADER, DSUR, RMP.

Manager

Assistant Manager
Individual contributor:
As a individual contributor working on PSUR, PBRER, PADER, DSUR, RMP.

Managing Aggregate reporting team
Managing ICSR Team

Individual Contributor
Drafting and Reviewing Aggregate reports viz PBRER, PSUR, ACO, RMP
Direct client communications
Recruitment of new hires

Assistant Manager

Working on innovator molecules in preparation of Aggregate reports, Signal reports and reviewing of the below reports.

a) Signal detection
b) Aggregate Safety Reports ( PSUR, PBRER, RMP, EURMP)
c) Literature review
d) Responding to Health authority queries
e) Developing Work Instructions for pharmacovigilance activities
f) Allocation and Compliance of Signal Detection reports

Other activities allocated by my senior managers.

SCIFORMIX TECHNOLOGIES PRIVATE LIMITED

Senior Lead Medical Writer

The aggregate report writing activity, encompasses preparation of the following reports: Periodic Benefit Risk Evaluation Report (PBRER), Periodic Safety Update Report (PSUR) and abbreviated PSUR (Ab PSUR), Addendum to Clinical Overview (Ad CO), Addendum Report, Summary Bridging Report (SBR), and Periodic Adverse Drug Experience Report (PADER).

Additionally, preparation of responses to Assessment Reports from Health Authorities or ad hoc report is also undertaken. The process also includes initial preparatory activities, such as Line Listing (LL) and Summary Tabulation (ST) generation and review, approval from respective reviewers [Point of Contact, (POC)], case-correction activity and finalisation of the Line Listing for appending in the final report. It also includes analysis of published literature and approval from POC.

Preliminary Activity and Report Draft Preparatory Activity (Lead author)
 Generation and review of LL and ST from safety database
 Selection of relevant *literature articles for inclusion in report
 Verification of data sources for any inappropriateness, discrepancy or missing data
 Obtaining POC approval of LL and ST and ensuring necessary case correction (as appropriate),
 Obtaining confirmation of selected literature articles and any clarification on data sources (as appropriate)
 Assimilation of all data sources for draft preparation, including full text of selected literature as appropriate
 Obtaining medical inputs and critical analysis on certain sections of the report from assigned medical reviewer
 Preparation of draft for internal review
*Intimation to literature review team to provide literature search results (TL or lead author)

Bioclinica

Aggregate report writer / Medical Writer-TL

Medical Writing

Perform Aggregate regulatory report writing activities on the assigned project in a timely and efficient manner.

To organize/attend the Kick off meeting for the allocated Annual Product Review/ Product Quality Review (APR/PQR), PADER/USPR report and ongoing safety monitoring..

Assist in preparation of Periodic Safety Updated Report (PSUR) and addendum report as per client standard operating procedures (SOPs) and Work instructions (WIs).

Review APR/PQR reports as per client SOPs and WIs.

Capture of quality data for metrics reporting.

Ensure the completeness and accuracy of the source documents provided by the client for APR/PQR and PADER.

Schedule meetings with client single point of contact (SPOC) to resolve report related queries.

Report to the manager on performance status and any escalations.

Ensure all the records and documents are maintained as per organizational requirements.

Drafting of Safety Narratives encompassing therapeutic areas Oncology, Immunology, and Rheumatoid Arthritis, Diabetes according to client specific style guide and ICH-GCP guideline E3 

Performing Quality Review of Safety Narratives using specific Quality checkpoints and conventions. 
Conducting Huddles on regular basis and resolving queries with other offshore teams.
Conducting team meetings, preparing Minutes of meeting (MOM) for kick-off meetings.

Hands-on work on preparing resource utilization reports/Attendance tracker/Leave Planer/case allocation/Quality Check  (QC) Feedback report/ Workflow management/ Accuracy report generation/  and other metrics.

Cognizant Technology Solutions

Medical Writer

Drug Safety Associate: 

-To work on drug safety data base ARISg.
-To work with clinical, spontaneous, NIS and NIP cases.
- Accountable for handling ICSRs disposition of valid items into ARIS from IRT for further processing in ARISg (case initiations).
- Accountable for performing accurate data capture for individual case safety reports which can be spontaneous, clinical, NIP and NIS cases.
- Accountable for performing the appropriate clinical assessments (including the assessment of seriousness, labeling and company causality for each adverse event) adhering to SOPs/other controlled documents and regulatory requirements. 
- Responsible for developing a collaboration with relevant Drug Safety Personnel for maintaining awareness of critical AEs, knowledge of labeling documents, and other issues for company products.
-Ensured that monthly Service Level Agreement (SLA) met for expected production, quality and compliance and effectively communicated with supervisor for any unusual trends.

Mayank Barg