Dilip Mishra
Team Lead at Apcer Life sciences| 10+ Years in Pharmacovigilance | Experience with Bioclinica, Cognizant & Quintiles | Drug Safety & Compliance Expert | Open to New Opportunities in PV Leadership Roles
- Role
- Team Lead Pharmacovigilance at Apcer Life Sciences
- Location
- New Delhi, DL, IN
- LinkedIn followers
- 500 followers
About Dilip Mishra
Overall 11 years experience in Pharmacovigilance (Drug safety). Working as a team…
Experience
Team Lead Pharmacovigilance
Nov 2021 — Present · New Delhi, IN
Team leaderOversee the workflow IN & OUT of cases according to the timeline.Oversee internal quality control activities to ensure data accuracy, completeness, and compliance with regulatory requirements.Develop and revise pharmacovigilance SOPs as needed to align with changing regulatory requirements and industry best practices.Client/partner communications & query handlingEnsure the accurate and timely entry of adverse event data into the safety database.Review and approve individual case safety reports (ICSRs) before submission to regulatory authorities.Updated with global pharmacovigilance regulations and guidelines (FDA, EMA, TGA, ICH, etc.) and ensure compliance with all relevant requirements.Promoted a positive work environment by fostering teamwork, open communication, and employee recognition initiatives.Provide training to internal staff and external partners on drug safety processes, adverse event reporting, and regulatory requirements.Enhanced overall team performance by providing regular coaching, feedback, and skill development opportunities.Prepare and present drug safety metrics and operational performance reports to senior management and stakeholders.Established clear performance metrics for the team which helped in tracking progress towards set targets effectively.
Education
L.B.S. College of Pharmacy
Bachelor of Pharmacy (B.Pharm.)
2006 — 2010
Amravati University
Master's degree
Govt. College Of Pharmacy
M. Pharmacy
2011 — 2014
S.S. Jain subodh sr. sec. school, Jaipur
Secondary education
2003 — 2005
Skills
- Regulatory Affairs
- Pharmacology
- Clinical Trials
- Pharmacovigilance
- R&D
- Pharmaceutical Industry
- Drug Safety
- Analytics
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