Qppv

Have sufficient authority to influence the performance of the quality system and the Pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements
- Prepare, write and update SOPs of the pharmacovigilance department and ensure that all activities are implemented according to the SOPs
- Handle and process as applicable all spontaneous and solicited safety reports as ICSRs as per the company and regulatory obligations and submitting them as per regulatory timelines (as per contract)
- Review with appropriate team members individual product signal detections, weekly case reports. (as per contract)
- Manage preparation and Submission of PSURs and addendum to clinical overview, as applicable, according to the regulatory obligations and timelines. (as per contract)
- Manage preparation and Submission of RMPs, as applicable, according to the regulatory obligations and timelines. (as per contract)
- Manage preparation and Submission of Safety Variations, as applicable, according to the regulatory obligations and timelines. (as per contract)
- Serves as Point of contact for the Regulatory authorities for any safety question
- File, store, and archive safety-related data.
- Prepare for audits/inspections from regulatory authorities or contracted MAH or internal audits to ensure compliance with company and regulatory obligation.
- Participate in audit and inspection preparation on the contracted MAH as applicable as per contract.
- Deliver training to PV staff and non-PV staff and any third party as required.
- Participate on company sponsored committees and councils and represent the company at external safety meetings
- Comply with Pharmacovigilance regulations and Global Safety policies/procedures and when needed take corrective action.
- Oversight of contractual arrangements with partners
- Reviewing pharmacovigilance part and safety issues in Protocols of clinical trials and/or studies

**Job Types**: Full-time, Contract