Anchal Shukla
Senior Manager, International Pharmacovigilance @Merck Sharp & Dohme LLC (MSD)|| Ex- Abbott; Sun Pharma
- Role
- Senior Manager - International Pharmacovigilance (Ipv) at MSD
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
About Anchal Shukla
Pharmacovigilance professional with 11 years of work experience with major pharmaceutical…
Experience
Senior Manager - International Pharmacovigilance (Ipv)
Jun 2022 — Present · Gurugram, IN
Responsible for adverse event management including aggregate and individual case safety report (ICSR) health authority submissions and compliance monitoring.• Responsible for PV activities for India and Neighbouring countries (Bangladesh, Bhutan, Nepal, Maldives, Pakistan and Sri Lanka): PV intake, management and negotiation of local PV agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, SOP management, local training, communication of safety issues, people development, special projects as assigned.• Serving as a Back-up (BU) local Qualified Person for PV (QPPV)/BU Local PV Contact / BU Local Responsible PV person as required per local PV legislation (Deputy Pharmacovigilance Officer Incharge).
Skills
- Clinical Research
- Healthcare
- CRO
- Ich
- Pharmaceutical Industry
- Sop
- Fda
- Drug Safety
- Psurs
- Clinical Trials
- Gcp
- Clinical Data Management
- Clinical Monitoring
- Regulatory Submissions
- Edc
- Meddra
- Ctms
- Signal Processing
- Ich-Gcp
- Patient Recruitment
- Protocol
- Pharmacovigilance
- Medical Writing
- Quality Control
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