Pharmacovigilance Executive

  • Vadodara
  • 3 - 5 year(s)
  • full-time
  • 1 opening(s)

Role & responsibilities

  • Manage pharmacovigilance activities including adverse event reporting and vigilance documentation.
  • Ensure compliance with USFDA, EU MDR, ISO 13485 and global regulatory requirements
  • Prepare pharmacovigilance data, safety reports, and regulatory submissions/dossiers
  • Conduct post market surveillance, risk assessments and trend analysis
  • Handle product recalls, field corrective actions, and regulator communications
  • Support product registrations, renewal and audits across global markets
  • Liase with cross functional teams (R&D, Quality, Manufacturing) for compliance.

Preferred candidate profile

  • Strong knowledge of pharmacovigilance reporting systems, dossier filing and regulatory submissions.
  • Strong Analytical, documentation and communication skills.
  • Regulatory compliance mindset

Apply now

Detailed Education

10th / SSC
12th / HSC
Graduation (Diploma/Degree)
Masters/PG

Company Experience

Company 1

Further Information

Shaily Engineering Plastics Ltd – A Place to Thrive & Grow!

Founded in 1987, Shaily has become one of India’s largest exporters of plastic components, trusted by global leaders like IKEA, Procter & Gamble, and Siemens. With over 2,000 employees across seven state-of-the-art manufacturing units, we are dedicated to shaping futures, igniting innovation, and building a culture of excellence.

Our commitment to quality, safety, and ethical operations is reflected in our global certifications, including ISO 9001, IATF 16949, ISO 13485, ISO 15378, MDSAP, ISO 14001, ISO 50001, and ISCC. We also comply with FDA 21 CFR 820 QMS requirements, SA 8000, AEO, and GSV/SCAN, reinforcing our trust in international supply chains. At Shaily, we don’t just meet standards — we set them, driving continuous improvement and maintaining the highest levels of compliance.