A Regulatory Affairs and Pharmacovigilance Officer is responsible for ensuring compliance with regulatory requirements and managing the safety of pharmaceutical products. This role involves tasks such as submitting regulatory documents, communicating with regulatory authorities, assessing the safety profile of drugs, managing adverse event reporting, and implementing risk management strategies. The officer plays a crucial role in navigating the complex landscape of regulations and ensuring that pharmaceutical products meet stringent safety standards throughout their lifecycle.

MAJOR RESPONSIBILITIES & DUTIES:
-Act as the local safety officer in accordance with requirements set out by the ministry of public health in Lebanon and the suppliers.
-Availability on a 24/7 basis to receive PV cases.
-Act as the contact point for PV inspections/Audits.
- Responsible for responding to scientific and medical information requests at local level.
-Responsible for website screening.
-Management of the SDEA with suppliers and distributors.
-Responsible for ICSR management.
-Provide basic pharmacovigilance training to all employees at Darapharma and to distributors.
-Collaborate with the other parties and the global QPPV with respect to the implementation of risk minimization measures in the territory.
-Prepare and follow the PV reconciliations periodically.
-Remain up to date and aware of any changes in local regulatory requirements related to drug safety.
- Report on medication and other treatment safety updates.
- Signaling early warning indicators of medication side effects.
- Assist in the preparation and review of new product documentation intended for submission or variation to the Ministry of Health (MoH). This involves tasks such as examining essential documents and reviewing scientific and legal materials.
- Create electronic regulatory cover letters for all submissions.
- Ensure that all documents adhere to the regulations set forth by Lebanese authorities and meet the requirements of the MoH.
- Manage the receipt and transmission of invoices.
- Check periodically the price index.
- Collaborate with the Regulatory Affairs (RA) department regarding updates in Lebanese drug regulatory legislation and guidelines.
- Monitor and track the company's progress in meeting the forecast for regulatory drug submissions, working closely with the RA.
- Take responsibility for backing up and organizing files, both electronically and manually, in coordination with the RA, ensuring they are easily traceable.
- Gather and distribute all technical and regulatory documentation internally.
- Communicate with the RA and suppliers to gather all necessary documentation required by the MoH.
-Notify and share all relevant regulatory updated information with suppliers.

QUALIFICATION AND BACKGROUND REQUIREMENTS:
- Bachelor’s degree in Pharmacy.
- At least 2 years of relevant experience.
- Well organized, strong attention to details.
- Availability by phone 24/7 for any inquiries.
- Proficient use of Microsoft Word, Excel, PowerPoint and PDF/Acrobat.
- Strong communication skills.
- Self-motivated.
- Can work independently and within a team.
- Languages Required: Arabic – English, French is a plus.
- Excellent analytical and problem-solving skills.
- Ability to interact and communicate effectively with a wide range of people