Pv & Quality Officer, Qppv - Ksa
7 months ago
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
PV & Quality Officer, QPPV
KSA, Riyadh
**Job Description**:
Lead development and execution of Quality and Pharmacovigilance Compliance priorities for all product classes (medicinal products, medical devices, cosmetics) in KSA, in coordination with the distributor(s) and service providers with the support from the regional heads.
Hold the responsibility to establish and maintain Galderma’s pharmacovigilance system in KSA.- Provide strategic directions to the business, accountable for delivering project goals and aligning Quality and PV strategies with business needs.
Operational execution of activities within Quality and PV
Job Responsibilities
Lead Pharmacovigilance:
- Act as the Qualified Person for Pharmacovigilance (QPPV) and Local Safety Officer (LSO) for Galderma KSA- Maintain the local PV System including the quality system and monitor its compliance status- Maintain the National pharmacovigilance sub-system file (PSSF) in KSA and contribute to the update of the Pharmacovigilance System Master File- Has sufficient authority to ensure and to verify that the information contained in the PSMF is an accurate and up-todate reflection of the pharmacovigilance system under the local QPPV’s responsibility.- Promotes compliance to PV regulations- Manage the creation/update of local PV SOPs to reflect local practices in accordance with Corporate Policies and SOPs in alignment with Saudi FDA requirements.- Coordinate with Galderma Middle East and Global PV for the establishment and maintenance of Safety Data Exchange Agreements (SDEA), for PV requirements and effective management of adverse events and aggregate reports- Support the Pharmacovigilance activities managed by the KSA Partners’ Local Safety Officer (LSO) to ensure compliance with regulations and Company’s guidances; coordinate and exchange key information with the Global Pharmacovigilance team and EMEAC PV Head/EU QPPV- Perform Pharmacovigilance specific tasks including but not limited to processing spontaneous and solicited safety reports as ICSRs, Literature monitoring, aggregate reports administrations and submission according to local regulations and other PV activities as required e.g., data reconciliation, signal alerts and archiving, update on the safety agreements and preparation for internal audits or Health authority inspections- Receive spontaneous reports of adverse events, follow-up adverse events as comprehensively as possible, communicate adverse event information to the Global Pharmacovigilance department, and report adverse event information to relevant regulatory authorities- Coordinate with global PV team updates in the local requirements related to periodic reporting and required format and covered period to support preparation of the global PV calendar- Manage and submit Periodic Safety Update Reports (PSURs), according to national standards for products in scope, in co-operation with Global Pharmacovigilance- Ensure compliance with local regulations and internal processes; coordinate PV audits of partners with Galderma Middle East and Global Pharmacovigilance- Ensure delivering annual refresher PV training for Galderma KSA staff and Partners’ LSOs- Lead local health authority inspections in with regards Good Pharmacovigilance Practice regulations- Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g. variatio
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