Salman
New Delhi
Summary
An expert pharmacovigilance professional having 9 years of experience with a proven track record of delivering results with utmost quality within the definite stipulated time. A leader on which a team can rely and deliver maximum results. Mastery of all aspects of pharmacovigilance.
Overview
10
10
years of professional experience
1
1
Certification
Work History
SENIOR SAFETY SPECIALIST/Team Lead
Syneos Health
Haryana
10.2021 - Current
- Workflow management for QC team (20 members) and maintaining track of cases for locking on time.
- Review of cases in various stages like Intake, booking, Triage, processing, and complete quality review of coding of adverse events related to drugs/medical devices: Prefilled pens, syringes etc.
- MEDRA coding, WHO drug coding, and device coding expertise
- Effectively communicate with managers, team members, and client contacts.
- Product Lead/Team Spoke.
- Mentor-ship for new hires, Training Program lead, useful tool generator.
- Subject matter expert in solving case processing doubts.
- Able to encourage staff, with strengths in forming strong relationships with clients as well as projects.
- Monthly engagement in client meetings for challenges and new learning.
- Productivity calculations for each QC team member for performance evaluation.
- Troubleshooting any error arising in a project within the stipulated timeline.
- Arranging Training and development plans for new associates.
- Data compilation of Qcied cases for monthly billing on excel and well versed with excel functions like pivots, charts, formula's and much more.
- Well-versed in Authoring PADER and PBRER/PSUR
- CAPA Handling and organizing team huddle for quick update and major updates.
- Well versed in processing all kind of ICSRs.
- Communicating with all global PV affiliates.
- Monthly and weekly trend analysis of internal, external errors.
SAFETY SPECIALIST II
Syneos Health
Haryana
09.2019 - 10.2021
- Certification in drafting PSUR/PBRERs and PADERs of various medicinal products. Prepared dummy PBRER reports and PADER reports.
- Listing of SUSARs in PADER reports and assessing expectedness per USPI.
- Processing of all kind of ICSRs for drug/device including Fatal/LT cases, PMS cases, regulatory cases, named patient program, Non-international studies/programs, spontaneous, literature, discharge summary, market research, legal and all special situation cases.
- Among the top three performers for multiple months.
SAFETY SPECIALIST I
Syneos Health
Haryana
04.2017 - 09.2019
- End to End Case processing on Safety database tool Argus.
- Learning client-specific SOPs.
PHARMACOVIGILANCE OFFICER
WIPRO
New Delhi
04.2016 - 03.2017
- Involved in compiling ADRs (adverse drug reaction) forms for the ADRs reported by HCPs and consumer, thus creating raw data for ICSR processing on client specific tool.
CLINICAL BUSINESS EXECUTIVE
Nestle
New Delhi
08.2015 - 12.2015
- Involved in Marketing segment which helped to become good strategy maker.
BUSINESS EXECUTIVE
Ranbaxy
07.2014 - 06.2015
- Involved in Marketing segment and new product launch.
Education
MBA - Operations Management And Supervision
IGNOU - Delhi
11.2022
Bachelor of Pharmacy -
DIPSAR - New Delhi
07.2014
Skills
- Data Analysis
- Literature Review
- ICSR Management
- Operations Management
- Training Coordinator
- Well-versed with signals
- Product Lead/Team Lead
- Quality Improvement
- Trend Analysis
- Subject Matter Expert
Affiliations
- I love to play Cricket and enjoy with family in my free time.
- Meditate to remain calm always and love to engage with my old friends.
Certification
- Certified Pharmacist
- Certification in Advanced excel
- Ongoing Certification Program in power BI cloud and desktop
- Ongoing Certification in Pharma Business Analytics.
Timeline
SENIOR SAFETY SPECIALIST/Team Lead
Syneos Health
10.2021 - Current
SAFETY SPECIALIST II
Syneos Health
09.2019 - 10.2021
SAFETY SPECIALIST I
Syneos Health
04.2017 - 09.2019
PHARMACOVIGILANCE OFFICER
WIPRO
04.2016 - 03.2017
CLINICAL BUSINESS EXECUTIVE
Nestle
08.2015 - 12.2015
BUSINESS EXECUTIVE
Ranbaxy
07.2014 - 06.2015
MBA - Operations Management And Supervision
IGNOU - Delhi
Bachelor of Pharmacy -
DIPSAR - New Delhi
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