Milind Mali
Process Lead (Global Pharmacovigilance) at TCS Expert in ICSR, Aggregate Report | Medical Writer | PV-QR | Management | QMS | PV-SME | Trainer| Mentor| End to End Drug Safety Operations.
- Role
- Process Lead (Global Pharmacovigilance Operations) at Tata Consultancy Services
- Location
- Indore, MP, IN
- LinkedIn followers
- 500 followers
About Milind Mali
Senior Pharmacovigilance professional with 10+ years of experience in global drug safety…
Experience
Process Lead (Global Pharmacovigilance Operations)
Mar 2020 — Present · Mumbai, IN
Proactive work flow management and daily task assignment• ICSR query point of contact, L&P deletion responsible, team production data• Daily planning, assigning and directing work and insure internal, regulatory, LP timelines met also were expedited accordingly• Point of contact to share the trend analysis, deviations, and compliance cases in all safety groups• Preparation and presentation of weekly quality SLA score of team & individual quality, production, training\'s compliance, field level errors, RCA levels & overall preventive measures and share the same with stakeholder and customers• Participating in teleconference with difference agenda’s such as client interactions, work load, cases discussion, quality analysis, process improvement & other adhocs• Collect, analyses, review and submission of RCA, CAPA & deviation plans to management and fixed them (have basic knowledge of SOPs/service level agreement and key performance in indicators)• I do involved in capacity, resources utilization, steering of new hires, access related and training aspects• Handling team meetings with different agenda like query resolutions, refreshers, mail & , workload discussion• Monitoring quality compliance as well as gaps and initiate appropriate CAPA actions, Cooperate with the groups affiliates, regions and all other stakeholders in order to ensure compliance and inspection readinessSubject Mater Expert/Mentor:• End to end mentoring of new hires-mentees, alignment of mentors to mentee and daily task allocations and WF aligning• Supervision and co-ordination with mentees to understand and train with complete processing handling and release to WFs• Take weekly sign of projections and approval of new hires across location• Conducting sign off review meetings & designing and implementing specific training initiatives to productivity & quality• Process expert global pharmaco and device vigilance, product responsible, PVA and SDEA management, query management
Education
Dr.D.Y. Patil Institute Of Pharmacy
Bachelor’s Degree
2011 — 2015
Dr. V. M. Jain high school, Parola, Dist- Jalgaon.
S.S.C
2007 — 2009
Dr.V.M.jain Secondary school, Parola Dist-Jalgaon
H.S.C
2009 — 2011
Dr.D.Y.Patil Institute Of Management and Research
Master’s Degree
2015
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