pharmacovigilance Officer – RAY
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 Location:||Muscat, Oman|
|Job Role:||Research and Development|
|Company Industry:||Scientific Research & Development; Pharmacies; Healthcare, other|
|Career Level:||Entry Level|