Maheedhar Kotla
Manager at Cencora Pharmalex
- Role
- Manager at Cencora Pharma Solutions
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
Experience
Manager
Oct 2022 — Present · Hyderabad, IN
Prepare, review and manage Periodic Safety Update Reports (PSUR), Periodic Benefit Risk evaluation reports (PBRER), Risk Management Plan (RMP), Periodic Adverse Drug Experience Report (PADER), Addendum to clinical overview (ACO), Development and Safety Updatev Reports (DSUR), Health Authority request and Signal detection activity. Line Management and Cross functional activities. Collaborating internal and external stake holders and ensuring to be in compliance with local and PV legislations. Serves as and SME for the team.
Skills
- Pharmacovigilance
- Gmp
- R&D
- Medical Writing
- Gcp
- Clinical Research
- Pharmaceutical Research
- Validation
- Formulation
- Regulatory Submissions
- Drug Delivery
- Clinical Trials
- Drug Discovery
- Glp
- Protocol
- Pharmaceutical Industry
- Sop
- Fda
- Clinical Development
- Life Sciences
- Ich-Gcp
- Pharmacokinetics
- Pharmacology
- Microsoft Word
- Anda
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