Opella is a global leader in the Over-The-Counter (OTC) and Vitamins, Minerals & Supplements (VMS) market, dedicated to simplifying self-care for over half a billion consumers worldwide. With a portfolio of 100+ trusted brands—including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale, and Mucosolvan—Opella operates across 13 manufacturing sites and 4 innovation centers.
As a B Corp certified organization, Opella is committed to fostering healthier lives and a sustainable planet. Learn more at www.opella.com.
Job Description
Key Responsibilities:
- Conduct quality oversight for Individual Case Safety Reports (ICSRs) to ensure compliance with global pharmacovigilance regulations (FDA, EMA, ICH).
- Perform ICSR quality analytics, track findings, and implement CAPA (Corrective and Preventive Actions).
- Analyze in-process quality checks (QC) and off-line QCs, identifying deviations and root causes.
- Lead continuous process improvements in Case Management (CM) & Medical Evaluation.
- Oversee vendor quality management, ensuring consistency in CM functions.
- Prepare ICSR quality reports, trend analysis, and present findings to stakeholders.
- Maintain SOPs, job aids, and QMS (Quality Management System) documentation.
- Ensure timely ICSR submissions and compliance with GxP & GVP guidelines.
Required Skills & Qualifications:
- Experience: 6+ years (5+ in pharmacovigilance), including case processing, CAPA, deviations, and QMS.
- Technical Skills: Proficiency in Argus, Aris-G (LSMV), Vault Safety, and Microsoft Office.
- Regulatory Knowledge: Strong understanding of ICH GVP, GxP, CIOMS, EudraVigilance, and FDA REMS.
- Soft Skills: Strong communication, problem-solving, stakeholder management, and analytical skills.
- Education: Bachelor’s degree in Pharmacy / Life Sciences or related field.
Why Join Opella?
At Opella, you’ll work in a challenging, purpose-driven environment with opportunities for growth and innovation. The company fosters a bold, collaborative, and inclusive culture where employees thrive.
Core Values:
✅ All In Together – Teamwork & transparency
✅ Courageous – Innovative & boundary-breaking
✅ Outcome-Obsessed – Accountable & results-driven
✅ Radically Simple – Making healthcare simple
Company: Opella
Location: Hyderabad, Telangana, India (On-site)
Experience Required: 6+ years (5+ years in pharmacovigilance)
Job Type: Full-time
