1 August, 2022
Organon Hiring Manager Pharmacovigilance & Regulatory Affairs
Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.
We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.
At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.
It’s going to be an exciting future—come be a part of it!
Organon – Manager Pharmacovigilance & Regulatory Affairs
Our Regulatory Affairs / Pharmacovigilance team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
What Will You Do
Responsible markets: India + 6 other distributor markets
- PHARMACOVIGILANCE ACTIVITIES:
- Serves as the as the local Qualified Person for PV (QPPV) / Local Responsible PV person (LRP) or back-up QPPV/LRP as required per local PV legislation.
- Oversees all daily PV processes and activities within the countries covered by the country operation.
- Establishes and coordinates reconciliation processes of AE reports received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable.
- Coordinates the filing, storage and archiving of safety-related documentation in accordance with company’s policies and local requirements.
- Participates in compliance activities and coordinates the preparation of necessary corrective actions locally for late reporting countries covered by the country operation
- Support country RA PV lead in audits/inspections for countries covered by the country operation and actively participates in the audit and/or inspection. Provides recommendations of corrective and preventive actions (CAPA) and track CAPA commitments to address findings/observations and monitors until closure.
- Participates and supports audits of contractual partners/vendors as necessary.
- Develop local standards and procedures (in compliance with regional and global standards) for the department, to ensure quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.
- Support maintenance of local PV controlled documents (i.e., SOPs, training materials, CCPD (where applicable)) ensuring that they are kept updated
- Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
- Support country RA PV lead in training of PV staff (including maintenance of the local training matrix and onboarding plans) and supports the required training of the local company staff, distributors, vendors, business partners in the countries covered by the country operation, including training documentation.
- Support country RA PV lead in reviewing and approving local initiatives (e.g. digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable.
- Support country RA PV lead in ensuring appropriate implementation and oversight of Risk Minimization Measures, and Additional Risk Minimization Measures locally as per department policy and ensures compliance with local legislations.
- Provides expertise in the planning, execution, and maintenance of major projects.
- STAKEHOLDER MANAGEMENT (INTERNAL & EXTERNAL)
- Internal stakeholders: Manage stakeholders- marketing, D&L, distributors, Marketing partners ,finance, market access, Govt affairs, medical affairs , Quality team, legal etc.
- External stakeholders: Central and state FDA.
What You Must Have
Graduate / Post graduate in Pharmacy with minimum 3 years or more working experience in Pharmacovigilance in pharmaceutical company.