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Senior pharmacovigilance scientist

4 months ago

Hyderabad, Telangana, India ProPharma Group Full time

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.

Job Summary:

Authoring and review of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities. Authoring and review of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities. Authoring /Quality Review of Signal Management Reports. Performing literature search and validity check for the aggregate reports. Management and reconciliation of relevant process trackers. Subject matter expert (SME) along with training and mentoring of individuals. 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. Interacting with appropriate client personnel to resolve issues related to the Aggregate reports as per clients' policies. Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines. Significant experience in lit screening activities and/or authoring and reviewing aggregate reports and/or experience in authoring and updating RMPs and/or Significant knowledge of signal detection methodologies and/or experience managing CCDSs and knowledge of regulatory safety variation processes

Essential Functions:

Drafting and review of PBRER, PSUR, DSUR, PADER, RMPs, Annual Report and Signal reports, literature review and analysis, having knowdgle on CCDSs .

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:

PhD, M-Pharmacy/B-Pharmacy, Doctor of Pharmacy (PharmD) from PCI recognized University/College.

Experience Requirements:

Preferred: 2-5 years of experience in authoring ARs and at least 1-2 year of exposure to Quality review of aggerate reports, literature screening

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 does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***