Akash Sharma
PV Agreements and Alliance Management
Mumbai,Maharashtra
Summary
Seasoned Pharmacovigilance professional with over 13 years of experience in PV processes across major organizations. Expertise in Regulatory Compliance, compiling PSMF, supporting QPPV, writing Safety Data Exchange Agreements (SDEAs), Quality Management, and Team Leadership. Adept at managing end-to-end PV workflows, developing SOPs, conducting partner evaluations, and preparing periodic safety reports. Proven ability to foster collaboration, ensure compliance with global standards, and deliver high-quality results. Skilled in using various tolls and proficient in healthcare analytics and technology applications.
Overview
15
15
years of professional experience
1
1
Certification
Work History
PV Partnership Senior Expert
Merck Group
Mumbai
08.2021 - Current
- Oversee EU-QPPV on SDEAs and partner qualifications.
- Maintain PVA templates and SOPs aligned with business and regulatory needs.
- Negotiate and implement SDEAs with new partners efficiently.
- Evaluate Business Partner PV systems.
- Provide timely reports (PSMF Annex B3/B1, EU-QPPV updates, SDEA summaries).
Sr SDEA Specialist III
GlaxoSmithKline
Bengaluru
12.2015 - 12.2018
- Monitor GSK and partner compliance with SDEAs via reconciliations and checks.
- Communicate standard information to licensing partners with guidance.
- Represent during regulatory inspections and GSK partner audits.
- Maintain guidance documents and SOPs.
- Prepare error trending analysis and management monitoring.
- Support PSMF and periodic reports (PSUR, DSUR, DHCP, CCSI) related to SDEAs.
Team Lead
IQVIA
Bengaluru
04.2014 - 12.2015
- Train and orient new associates on pharmacovigilance.
- Act as SME to share technical and process knowledge with the team.
- Identify and report quality issues to management; demonstrate problem-solving skills.
- Attend project meetings and provide feedback on challenges or successes.
Medical Safety Specialist
Cognizant Technology Solutions
Navi Mumbai
06.2012 - 04.2014
- Evaluate ICSR information for medical completeness.
- Assess adverse events for potential seriousness upgrades using medical judgment and document decisions.
- Create and update case narratives.
Drug Safety Associate
Tata Consultancy Services
Navi Mumbai
10.2011 - 06.2012
- Process ICSRs/E2B files into ARIS 6.1.6 and manage duplicates per SOPs.
- Capture accurate data for ICSRs from various sources (spontaneous, clinical, NIS/NIP).
- Ensure compliance with Client Safety database using updated SOPs.
- Conduct and review literature searches to identify case safety reports and determine reportability.
QC officer
AnaZeal Analyticals & Research Pvt. Ltd
01.2011 - 10.2011
- Develop and validate analytical methods for biological samples using LC-MS/MS.
- Review method development, validation, and analysis data/reports.
- Ensure instrument calibration and compile results per GLP standards.
Education
Postgraduate Diploma - Healthcare Management
Loyola Institute Of Business Administration
Post Graduate Program - Health Economics and Public Health
Indian Institutes of Public Health (IIPHs)
11.2021
Bachelor - Pharmacy
Biju Patnaik University of Technology
06.2011
Skills
- SDEA
- PVA
- Negotiation
- QPPV
- Pharmacovigilance
- PSMF
- Audits and Inspections
- Regulatory Compliance
Certification
Fundamentals of Healthcare Quality Improvement, Udemy
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Accomplishments
Own Multiple Awards and Recognitions for the work in Pharmacovigilance field
Languages
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Bengali
Bilingual or Proficient (C2)
Marathi
Advanced (C1)
Urdu
Beginner (A1)
German
Beginner (A1)
Timeline
PV Partnership Senior Expert
Merck Group
08.2021 - Current
Sr SDEA Specialist III
GlaxoSmithKline
12.2015 - 12.2018
Team Lead
IQVIA
04.2014 - 12.2015
Medical Safety Specialist
Cognizant Technology Solutions
06.2012 - 04.2014
Drug Safety Associate
Tata Consultancy Services
10.2011 - 06.2012
QC officer
AnaZeal Analyticals & Research Pvt. Ltd
01.2011 - 10.2011
Postgraduate Diploma - Healthcare Management
Loyola Institute Of Business Administration
Post Graduate Program - Health Economics and Public Health
Indian Institutes of Public Health (IIPHs)
Bachelor - Pharmacy
Biju Patnaik University of Technology
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