1.0 - 6.0 years

10 - 15 Lacs

Gurugram

Work from Office

We are looking for MBBS - Medical Reviewer with 2-3 years of experience in Pharmacovigilance having expertise in review f aggregate reports. Candidate who are willing to come to office and work from office only can apply. Designation : Asst. Manager Department : Vigilance Competence Center Gurgaon, Qualification : MBBS/MD with 2-3 years of experience in pharmacovigilance with expertise in medical review of aggregate reports (PSURs/PBRERs) (required), with experience in performing medical review of signal management and ICSRs (recommended). Location : Gurgaon (Work from office is must with one-day flexi working option) Job Responsibility Design, develop and maintain procedures for medical review activities (ICSRs, aggregate reports and signal management). Ensure high quality of ICSR, aggregate and signal management deliverables. Perform medical review of ICSRs, aggregate reports (PSURs/PBRERs), Risk Management plans, and signal reports. Participate in/organize review of safety label updates. Mentor and train medical reviewers. Provide product and therapeutic area trainings for the PV team. Provide cross-functional training on pharmacovigilance to medical writing and ICSR team members. Behavioral Competencies Excellent interpersonal communication and writing skills with experience handling cross-functional projects Good conflict resolution skills Ability to work in a multi-cultural/global work environment Good mentoring skill

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Scientific Writing_Aggregate reporting Recruise India Consulting

3.0 - 8.0 years

7 - 12 Lacs

Hyderabad, Bengaluru, Mumbai (All Areas)

Hybrid

Level A4 – 3+ years Associate - Scientific Writing_Aggregate reporting Locations – across any nodal offices/Hybrid **Job Description:** **Responsibilities:** - Responsible for the entire document life cycle, maintaining quality, timeliness, and compliance with internal/client SOPs and regulations. - End-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, PSURs, SUSAR, PADERs/PAERs, ACOs, RMPs , and ad-hoc regulatory and safety reports. - Perform QC review of documents to validate accuracy and relevance, ensuring compliance with client-specific style and global standards. - Assist and mentor junior writers, provide guidance, and ensure consistency and completeness of reports. - Continuous process improvement in the team for developing content. - Participate in assigned training programs and create training materials and guidelines. - Interface with clients regularly to meet their expectations. **Qualifications:** - Medical/M.Pharm/Pharm D/life sciences degree. - Minimum 4 years of experience in medical writing or equivalent life sciences domain experience. - Knowledge of regulatory documentation, drug development process, and global regulations. - Excellent written and verbal communication skills, organizational and time management skills, and strong data interpretation and presentation skills. - Strong interpersonal skills and the ability to be flexible in varying environments. Indegene is proud to be an Equal Employment Employer committed to Inclusion and Diversity. We do not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions will be based on business requirements, the candidate’s merit, and qualifications. We are an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to any protected characteristics. Thank you for your attention to this matter. We look forward to receiving suitable profiles from you soon.

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