For the past 25 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. 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.
PV - Aggregate Report Writer
Full time & Office based
Location: Hyderabad
Job Summary
The Senior Pharmacovigilance (PV) Scientist supports the activities in the Benefit Risk group by ensuring that day-to-day operational activities are completed. The Senior Pharmacovigilance Safety Scientist, Benefit Risk 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 Senior Pharmacovigilance Safety Scientist is also expected to lead by example and ensures quality standards are upheld within the company.
Essential functions
- 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 safety database
- ·Providing reliable support for high priority Ad-hoc activities.
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 revelent Global regulations related to PV
- Demonstrable ability to analyze and quantify large volumes of data in a concise and scientific manner, 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, 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.
- 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/Power Point)
Educational requirements
- Bachelor/master’s degree in pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience
Experience Requirements
- 6+ 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 experiences in authoring and reviewing aggregate reports
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
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