PHARMACOVIGILANCE - MANAGER / Sr. MANAGER Hetero Labs Limited

0.0 - 1.0 years

3 - 10 Lacs

hyderabad, telangana, india

On-site

Responsible for handling end to end Case management (ICSRs) activities and to ensure the compliance. Manage assigned team and ensure that all tasks are performed according to guidelines and standard operating procedures. Consulting and guiding the pharmacovigilance team for completion of aggregate reports (PSURs, PADERs, RMPs and applicable regulatory submission PV documents) as required for regulatory submission To develop and review pharmacovigilance SOPs. Coordination with MICC for ICSR activities and regulatory compliance. Coordinating the safety data exchange agreements between Hetero and business partners. Responsible for providing guidance and training to team as and when required. Re...

Posted 1 week ago

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Sr Manager Regulatory Affairs - US Labeling Teva Pharmaceuticals

8.0 - 10.0 years

0 Lacs

bengaluru, karnataka, india

On-site

The Opportunity: The Senior Manager is responsible for setting strategic goals, managing, leading and developing teams, driving operational efficiency, and making high-level decisions that affect the teams success. In addition, will be responsible for the supervision, critical review, & approval of established US Gx labeling documents filed under an ANDA/505(b)2s while adhering to federal regulations, internal processes, & meeting timelines driven by company goals. Additionally, the Sr. Manager will oversee any/all team databases and trackers. The candidate must possess a firm knowledge of FDA US labeling regulations & guidance for products filed under an ANDA/505(b)2 and should be a SME in ...

Posted 3 weeks ago

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Medical Writer- Aggregate Reporting Theron Solutions

2.0 - 4.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Job Insights: Our client is seeking an ambitious and energetic Medical Writer for the authoring of aggregate safety reports to join their Safety team Responsibilities: Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations. Responsible for end-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports, send documents for review on a timely manner, liaise with subject specific stakeholders, set up review comments resolution meetings when needed, facilitate QC process, referen...

Posted 1 month ago

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Aggregate Report Writer Primus Global Technologies

2.0 - 6.0 years

5 - 10 Lacs

pune, delhi / ncr, mumbai (all areas)

Hybrid

Medical Writer (Aggregate Report Writer) • Experience: 2-6 years • Role: End-to-end authoring of complex deliverables including periodic aggregate reports (PBRERs, DSURs, SUSARs, PADERs/PAERs, ACOs, RMPs, and regulatory/safety reports) • Qualification: BPharm/Pharm D/M Pharm or any Life Sciences Degree. Locations Mumbai: Goregaon Pune: Baner NCR : still not decided between Gurgaon/Noida Hyderabad - Hi-tech city Bangalore - Manyata tech park

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Mgr Regulatory Affairs, Labeling Teva Pharmaceuticals

6.0 - 10.0 years

0 Lacs

karnataka

On-site

The Manager of Regulatory Affairs, Labeling at Teva Pharmaceuticals is responsible for supervising, critically reviewing, and approving established US Gx labeling documents filed under an ANDA/505(b)(2) by team members in the US and Mumbai/Bangalore locations. The Manager must ensure compliance with federal regulations, internal processes, and company goals while meeting established timelines. Additionally, they will oversee team databases and trackers, updating them as needed. The ideal candidate should have a strong understanding of FDA US labeling regulations and guidances for products filed under an ANDA/505(b)(2) and be a Subject Matter Expert in US labeling, including SPL, PADERs, and ...

Posted 2 months ago

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Regulatory Affairs Manager Teva Pharmaceuticals

8.0 - 10.0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

The Opportunity: The Manager is responsible for the supervision, critical review, and approval of established US Gx labeling documents filed under an ANDA/505(b)(2) by US and Mumbai/Bangalore (India locations) members while adhering to federal regulations, internal processes, and meeting timelines driven by company goals. The Manager will also be responsible for their own assignments, when needed, and working closely with other Managers surrounding the review and approval of labeling documents established for these projects. Additionally, the Manager will oversee all team databases and trackers and will update them when changes are required. The candidate must possess a firm knowledge of FDA...

Posted 3 months ago

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