Pharmacovigilance Job Opportunity at ProPharma | Apply now for a Pharma job
If you are searching for Pharmacovigilance jobs in India, this exciting Pharma job opportunity at ProPharma could be the right career move. ProPharma is hiring a Pharmacovigilance Safety Scientist in Bangalore for a full-time role with onsite/hybrid flexibility. Professionals with experience in aggregate report writing, signal detection, and regulatory compliance can explore this excellent opportunity in Pharmacovigilance jobs within the growing Pharma job sector.
- Position: Pharmacovigilance Safety Scientist
- Locations: India
- Job Requisition ID: JR 7763
About the 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 organisations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. 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.
Job Description
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 liaise 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.
Key Responsibilities
- Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities.
- Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
- Authoring of Signal Management Reports.
- Performing literature search and validity check for the aggregate reports.
- Reconciliation of relevant process trackers.
- Extraction and validation of data (RSI, Sales, previous reports, RMP, signals).
- Generation of Line Listings (LL) from the safety database
- Providing reliable support for high priority Ad-hoc activities.
Qualifications
Bachelor’s/master’s degree in pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience
Experience Requirements
- 2+ years’ experience in Pharmacovigilance with a focus on medical writing and/or literature search and/or signal detection
- Experiences in contributing to the compilation of metrics and participating in discussions about quality internally and with Clients
- Experience in literature screening activities and/or experience in authoring and reviewing aggregate reports
Necessary Skills and Abilities
- Analytical and problem-solving skills.
- Sound organizational skills
- Able to work within a team in an open and professional manner
- Excellent attention to detail and focus on quality
- Understanding of ICH-GCP, FDA, EMA, and other relevant Global regulations related to PV
- Demonstrable ability to analyze and quantify large volumes of data concisely and scientifically, in keeping with regulatory deadlines.
- Awareness of global culture and willingness to work in a matrix environment
- Knowledge in other pharmacovigilance processes, ability to author/update SOPs or WIs, and to identify and author deviations/CAPAs.
- Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines.
- The capability to make concise, accurate, and relevant synopses of medical text and data, and the ability to write unambiguous medical text
- Computer proficiency, IT skills, expertise, and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/PowerPoint)
