Pharmacovigilance Job at Opella – Apply Now!
Opella, a global leader in consumer healthcare, is hiring a Pharmacovigilance Product and Regulatory Associate in Hyderabad, India. If you have 3–4 years of experience in global PV databases like ARGUS or Aris-G, and expertise in regulatory compliance, case management, and safety reporting configurations, this opportunity is for you. Join us in ensuring patient safety and regulatory excellence in a collaborative, multinational environment.
- Job Position: Pharmacovigilance Product and Regulatory Associate
- Location: Hyderabad, Telangana, India
- Department: Global Consumer Healthcare Safety
About Opella
Opella Healthcare is the Consumer Healthcare division of Sanofi, a global biopharmaceutical company dedicated to improving health and well-being through trusted, science-backed healthcare products. With a strong legacy and presence in over 150 countries, Opella is committed to delivering self-care solutions that empower individuals to manage their health every day.
Key Responsibilities
- Collaborate with Country Safety Heads (CSHs), QPPV office, SDEA, and global teams to configure product/study/country-specific reporting rules in the global PV database.
- Oversee PV labeling documents in Veeva Vault and manage access rights.
- Support automated labeling integration for all CHC products in the Safety Database.
- Coordinate with SSDM and affiliates to configure distribution and reporting rules.
- Review weekly Veeva Flash Reports and Vault RIM updates for product lifecycle changes and ensure accurate configurations in CPD.
- Maintain CHC product mapping sheets and truncated product name lists.
- Track and implement regulatory intelligence updates in the global PV database.
- Support Annual Product Review and Distribution Rule Review with CSHs.
- Adhere to SOPs/QDs and support additional PV tasks and audits.
Pharmacovigilance Job at Opella – Required Experience
- 3–4 years in the pharmaceutical industry with a focus on pharmacovigilance.
- Hands-on expertise in PV safety databases such as ARGUS, Aris-G (LSMV), and Vault Safety.
- Proven experience in case processing, product configuration, and reporting rules setup.
- Familiarity with ICH GVP, GxP, and SDEA agreements.
- Strong knowledge of MS Office, especially Excel.
Soft Skills
- Strong communication, stakeholder management, and teamwork skills.
- Detail-oriented with analytical problem-solving abilities.
- Able to lead, think strategically, and operate in multicultural, cross-functional environments.
Pharmacovigilance Job at Opella – Technical Skills
- Deep knowledge of global pharmacovigilance regulations (FDA, EMA, ICH).
- Understanding of adverse event classification, CIOMS, EudraVigilance, and FDA REMS.
- Experience with safety database management and PV compliance.
- Skilled in Excel, Word, PowerPoint, and data presentation for stakeholders.
Pharmacovigilance Job at Opella – Educational Qualification
- Bachelor’s degree in Pharmacy, Life Sciences, or related fields.
- Desirable: 3–4 years’ experience with Global PV Databases and/or Case Management.
Language Requirement
- Fluent in English – written and verbal.
Why Join Opella?
- Be part of a global consumer healthcare leader with a mission to protect public health.
- Work in a high-impact pharmacovigilance role supporting global product safety and regulatory compliance.
- Collaborate with international teams and advance your career in PV & regulatory science.
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