The Pharmacovigilance (PV) Scientist supports the activities in the Benefit Risk group by ensuring that day-to-day operational activities are completed. The PV Safety Scientist is expected to be professional and diligent and liaises with the director and management group members within the team on any issues, as well as coordinate the work with the senior PV Scientists. The PV Safety Scientist is also expected to lead by example and ensure quality standards are upheld within the company.

Essential Functions:

1. Authoring of Aggregate reports (PSURS/PBRERS, PADERS/Annual Reports/ACO/DSIJR) for submission to local and other Health Authorities.
2. Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
3. Authoring of Signal Management Reports.
4. Performing literature search and validity check for the aggregate reports.
5. Reconciliation of relevant process trackers.
6. Extraction and validation of data (RSL Sales, previous reports, RMP, signals).
7. Generation of Line Listings (LL) from the safety database.
8. Providing reliable support for high-priority ad-hoc activities.
9. Literature (clinical & non-clinical, scientific) validity check, duplicate search in the respective tool for literature review.
10. Participating in internal/external audits/inspections as SME, if required.
11. Independently completing tasks such as the execution of literature searches.
12. Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines.

Necessary Skills and Abilities:

• Proficient computer knowledge and computer keyboarding skills.
• Proficient with Microsoft Office Suite (Outlook, Word, Excel).
• Strong verbal, written, and interpersonal communication skills.
• Strong organization and prioritization skills; able to multitask.
• Flexibility to adapt and meet fluctuating business priorities.
• Able to occasionally work extended and/or flexible schedule to meet client requirements.
• Must be proficient with commonly used software (Word, PowerPoint, Excel).

Educational Requirements:

• Bachelor’s Degree in biologic or natural science or Advanced degree (PhD, BPharm, BDS, MPharm, PharmD, etc.) preferred.
• Strong and proven background working within Pharmacovigilance, including experience in aggregate safety report writing and safety signal management.

Experience Requirements:

• Preferred: 1-2 years of experience in authoring ARs, 1-2 years of experience in literature search and review.