Bhavik Garach
PBRER | PADER | PSUR | RMP | ADCO | PSMF | Audit | Safety Variations | xEVMPD | AD-hoc reports | People Management | Training | PV Automation |
- Role
- Manager Pharmacovigilance (Aggregate Reports Writing) at Ipca Laboratories Limited
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Bhavik Garach
I am a highly motivated and organized Pharmaceutical professional with a knowledge and…
Experience
Manager Pharmacovigilance (Aggregate Reports Writing)
Nov 2020 — Present · Mumbai, IN
Responsible for the management and work allocation to the medical writing team. Responsible for effectively delegating the responsibilities among the team to leverage an individual’s skills for the benefit of the project. Also identify eligible candidates to upscale for leadership role. Responsible for the goal setting of the team, review the performance of the team members against the set goals and perform fair evaluation of their yearly performance appraisal. Responsible for people management. Involvement in PV audits (internal and external) and PV inspections. Identify gaps and areas of improvement in PV and lead remedial actions. Responsible for maintenance of real time compliance and oversight of Medical Writing activities. On board training and mentoring of new joiners in the team. Participating in the automation activity at different level. Generation and review of SOPs. Maintenance of safety variations Review and approval of PADERs/PSURs/PBRERs/AD hoc/Addendum reports (ADCO) and other medical writing documents. Review and approval of Risk Management Plans (RMPs) for EU and non-EU market. Review and maintenance of pharmacovigilance system master file (PSMF) for regulated markets and non-regulated markets. Update of products in XEVMPD database. CCDS reviews and approval process. Perform various support activities such as tracking, maintenance of Metrics and quality metrics. Prepare Company Specific Conventions in coordination with the head of pharmacovigilance. Resolution of queries received from health authorities.
Education
NIPER
Master of pharmacy, Pharmacy Practice
2008 — 2010
Shri Sarvajanik Pharmacy College, Mehsana, Gujarat
Bachelor of Pharmacy (B.Pharm.)
2004 — 2008
Skills
- Clinical Research
- Pharmacovigilance
- Clinical Monitoring
- Edc
- Ctms
- Clinical Development
- Oncology
- Sop
- CRO
- Gcp
- Clinical Trials
- Ich-Gcp
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.