Rizwan Shaik

About Rizwan Shaik

As an experienced Pharmacovigilance and Drug Safety professional with over 16 years of global experience, I bring deep expertise in regulatory compliance, ICSR management, safety systems, and pharmacovigilance operations. Currently serving as Deputy QPPV at Lupin Pharma, I provide strategic leadership across global PV functions, ensuring audit-readiness, seamless affiliate integration, and regulatory excellence. Throughout my career at top pharmaceutical firms like Lupin, Aurobindo Pharma, and Novartis, I have built a proven track record in: End-to-end safety operations, from case processing and literature screening to signal detection and expedited reporting Managing and maintaining Pharmacovigilance System Master Files (PSMFs), SOPs, and safety conventions Leading Argus Safety Database upgrades, validation, and optimization initiatives Reviewing and negotiating Safety Data Exchange Agreements (SDEAs) Driving global compliance, KPI tracking, deviation management, and CAPA implementation Facilitating inspection-readiness and documentation for US FDA and global audits Beyond operations, I have contributed to GCP and ethics training, participated in clinical trial design workshops, and authored academic research in pharmacology and formulation development. My early clinical research and production experience further enhance my end-to-end pharmaceutical understanding. With strong project management and cross-functional collaboration skills, I strive to ensure efficient, compliant, and high-quality pharmacovigilance systems that safeguard public health. Let’s connect if you’re passionate about drug safety, regulatory systems, or building high-performing PV teams.

Experience

1. Pharmacovigilance Global Affiliate Subsidiaries Manager

   Lupin

   Apr 2020 — Present · IN

   Actively lead global pharmacovigilance operations as Deputy QPPV, ensuring regulatory compliance through strategic oversight, effective stakeholder collaboration, and regional safety data exchange.• Proficiently author and maintain critical documentation, including Pharmacovigilance System Master Files (PSMFs), SOPs, guidance documents, and conventions tailored.• Efficiently manage affiliate and subsidiary integration by conducting regular oversight meetings, reviewing PV activities, and analyzing compliance metrics to ensure global alignment.• Diligently monitor regulatory intelligence and KPIs to ensure timely ICSR/PSUR submissions and adapt procedures proactively to evolving international PV regulations.• Skillfully negotiate and review Safety Data Exchange Agreements (SDEAs), ensuring clear roles, timelines, and compliance obligations among partners and vendors.• Proactively contribute to cross-functional PV initiatives, including global compliance audits, SOP updates, and continuous process improvements, demonstrating strong project management and regulatory acumen.

Education

• Jawaharlal Nehru Technological University Hyderabad (JNTUH)

  Master's degree

  2011 — 2013

• Kendriya Vidyalaya

  School

  1990 — 2001

• Manipal acunova cancer research center

  Internship

  2008 — 2008

• International education faculty for clinical research

  PGDCR

  2007 — 2008

• Goutham junior college

  Intermediate

  2001 — 2003

• P.R.R.M college of pharmacy

  Bachelor of Pharmacy (B.Pharm.)

  2003 — 2007