Job title: Pharmacovigilance Audit and Inspection Readiness Expert
- Location: Hyderabad
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.
Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.
At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at
www.opella.com
.
About the job:
Main responsibilities:
PV Inspection/ Audit & Training Support role is responsible for
- Participation in the ongoing permanent inspection preparedness and readiness of PV Operations in anticipation of regulatory inspections and audits.
- Active involvement in the preparation, conduct and follow-up of GxP regulatory inspections impacting PV Operations until closure.
- Active involvement in the organization of appropriate support for the preparation, conduct and follow-up of Global Quality audits impacting PV Operation activities, global PV processes/ tools or Business Partner audits, until closure.
- Responsible for Follow-up of audit/ inspections PV-related CAPAs to ensure timely completion and coordination of CAPA effectiveness reviews in collaboration with CAPA owners, as needed to prevent recurrence.
- Prepare for PV inspections/ audits from PV Operations perspective.
- Collaborate with countries for partner/ Global Quality Assurance (GQA) audit & HA inspection readiness.
- Facilitate development of responses to audit/ inspection findings where applicable.
- CAPA tracking for PV Operations related findings and coordinate activities to follow through completion.
- Deviation tracking for PV Operations Team and follow up with deviation owners for timely completion of deviation and related actions.
- Support PV Ops team to create and maintain training matrix for Case Management related activities for vendors and internal staff. Monitor training compliance for PV Ops team.
- Conduct PV focused mock inspections as per requirement.
- Conduct lessons learned meetings for PV Ops team as required from audit preparation perspective.
- Support PV Ops team with review of standard presentations for inspections and audits.
- Initiate and lead process improvements as needed pertaining to relevant audit, inspection preparation activities or training activities.
- Perform process gap assessment as required and implement risk registers.
- Create and maintain relevant SOPs, Job Aids, as needed.
- Other PV tasks as required.
- This role is responsible for ensuring audit and inspection preparedness, Audit/Inspection CAPA management, quality event/deviations management and CAPA effectiveness check monitoring.
- This position requires multiple interfaces with partners and customers within and outside of the Company
- This role involves understanding the constantly changing PV Regulations and ensuring that we follow them
About you:
Experience:
- Experience in PV Databases like ARGUS, Aris-G (LSMV) VAULT Safety, etc.
- Overall 6+ years of experience, with minimum 3 years of pharmaceutical industry experience with a focus on pharmacovigilance audits and inspections
- Experience with PV audits/inspections management is must
- Experience in overseeing vendors responsible for case processing.
- Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation
- Good knowledge of MS Office
- Strong experience with PV audits/inspection CAPA management
- Experience PV audits/inspection effectiveness check monitoring
- Experience with PV QMS systems and conducting PV mock audits.
- Experience overseeing PV training matrix and develop process if required
- Experience hosting PV inspection and audits
- Strong experience in ICSR quality review and submissions
- Incumbent should have experience in Process Improvement practices
Soft skills:
- Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions.
- Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities.
- Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams.
- Problem Solving: Proactively identifying issues within processes, systems, or data, and taking the initiative to solve them or propose improvements.
- Excellent team-work and interpersonal skills
- Ability to work in cross-functional teams
- Excellent oral and written communication skills
- Excellent networking and influencing skills
Technical skills:
- Regulatory Standards: In-depth knowledge of global pharmacovigilance regulations and guidelines, such as those from the FDA, EMA, ICH, and other health authorities.
- Knowledge of how adverse events are reported and classified (e.g., by severity, outcome) and the regulatory requirements surrounding these reports
- Safety Reporting Requirements: Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS, etc.) and experience in ensuring compliance with these standards.
- Good Pharmacovigilance Practices (GxP): Familiarity with GxP guidelines, ensuring that all pharmacovigilance processes adhere to industry standards.
- Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data.
- Microsoft Office Suite: Advanced skills in Excel (for data analysis and reporting), Word (for report writing), and PowerPoint (for presenting findings).
- Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way
Education:
Bachelor’s degree in pharmacy / Life Sciences / or equivalent Academic qualification is desirable with minimum 3 years’ experience in Global PV audits/inspections, CAPA Management, and PV risk analysis.
Why us?
At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
We Are Challengers.
We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
All In Together: We keep each other honest and have each other's backs.
Courageous: We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.
Join us on our mission. Health. In your hands.
www.opella.com/en/careers
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