ProPharma Hiring in Pharmacovigilance Safety Scientist
About Company
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Position Details
Position Name: Pharmacovigilance Safety Scientist
Organization: ProPharma
Location: India
Salary: ₹25,000 – ₹35,000 /month
Experience: 1 to 2 Years
Qualifications: B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Ph.D, BDS
Job Description
The Pharmacovigilance (PV) Safety Scientist supports the activities in the Benefit Risk group by ensuring that day-to-day operational activities are completed. The PV Safety Scientist liaises with the director and management group members, coordinates with senior PV Scientists, and ensures quality standards are upheld within the company.
Essential Functions:
- Author Aggregate reports (PSURS/PBRERS, PADERS/Annual Reports/ACO/DSIJR) for submission to local and other Health Authorities
- Author Risk Management Plans (RMPs)
- Author Signal Management Reports
- Perform literature search and validity check for aggregate reports
- Reconcile relevant process trackers
- Extract and validate data (RSL Sales, previous reports, RMP, signals)
- Generate Line Listings (LL) from the safety database
- Provide reliable support for high-priority ad-hoc activities
- Conduct literature (clinical & non-clinical, scientific) validity check, duplicate search for literature review
- Participate in internal/external audits/inspections as SME, if required
- Independently complete tasks such as the execution of literature searches
- Ensure deliverables to clients comply with regulatory requirements and are sent within agreed timelines
Necessary Skills and Abilities:
| Skill | Description |
|---|---|
| Computer Proficiency | Knowledge and keyboarding skills |
| Microsoft Office Suite | Proficient in Outlook, Word, Excel |
| Communication | Strong verbal, written, and interpersonal skills |
| Organization | Strong prioritization and multitasking skills |
| Flexibility | Adapt and meet fluctuating business priorities |
| Software Proficiency | Commonly used software (Word, PowerPoint, Excel) |
Educational Requirements
- Bachelor’s Degree in biologic or natural science preferred
- Advanced degree (PhD, BPharm, BDS, MPharm, PharmD, etc.) preferred
- Strong and proven background in Pharmacovigilance, including aggregate safety report writing and safety signal management
Experience Requirements
- 1-2 years of experience in authoring ARs
- 1-2 years of experience in literature search and review