Job summary
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 ensures quality standards are upheld within the company.
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 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 completion of tasks such as 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.
Essential Functions:
Drafting of PBRER, PSUR, DSUR, PADER, Annual Report and Signal reports, expert in literature (Clinical & non-clinical, scientific) validity check, duplicate search in the respective tool for literature review
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 requirement
- Must be good at commonly used software i.e (word, power point , 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 reports writing and safety signal management.
Experience Requirements:
Preferred: 1-2 years of experience in authoring ARs, 1or 2 years experience in literature search and review is required