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.
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.
Ensure all the reports are drafted within the allocated timelines
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.
Experience Requirements:
1-2 years of experience in authoring ARs and required experience in ICSRs
Educational Requirements:
PhD, M-Pharmacy/B-Pharmacy, Doctor of Pharmacy (PharmD) from PCI recognized University/College.
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.
ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving the pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio... Read More
