Drug Safety Specialist Fidelity Health Services

3.0 - 7.0 years

0 Lacs

maharashtra

On-site

As a Safety Data Exchange Associate at Fidelity Health Services, your role involves working on case processing and safety writing, with a focus on SDEA management. Your key responsibilities include: - Initiating communications with internal stakeholders such as business teams and subsidiaries to understand the requirements of SDEAs. - Following up with third parties/business partners to ensure SDEAs are in place. - Ensuring timely exchange of safety data with partners and conducting adverse event reconciliations. Qualifications required for this role include: - B. Pharm / M. Pharm/ BAMS/ BHMS degree. - Minimum 3-4 years of experience in case processing/ safety writing with knowledge of SDEA ...

Posted 1 week ago

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Senior/Lead Medical Reviewer Navitas Life Sciences

1.0 - 5.0 years

0 Lacs

karnataka

On-site

As a Senior/Lead Medical Reviewer with 1 3+ years of experience in Aggregate Reporting, Signal Management, or RMP, you will play a crucial role in our team. Your responsibilities will include overseeing the implementation of operational tasks in safety writing, monitoring service performance, and mentoring employees to ensure independent work within timelines, budget, and quality standards. Your duties will involve reviewing RMP/PSUR or any aggregate documents for medical cohesiveness, managing the logistical aspects of safety reports" development, and collaborating with authors from different line functions to meet client and Health Authorities" requirements. You will also be responsible fo...

Posted 1 month ago

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Functional Quality Specialist I Fortrea

2.0 - 6.0 years

0 Lacs

maharashtra

On-site

The responsibility of this role is to provide all clients, both internal and external, with high-quality service in a safe and cost-effective manner. You are expected to adhere to legal requirements such as the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3 as outlined in the Company's Health and Safety Manual. Your key responsibilities include: - Conducting quality reviews of assigned cases. - Compiling quality metrics based on reviews and identifying trends. - Assisting in client quality reviews and preparing corrective and preventive actions. - Ensuring implementation of CAPA results in coordination with project managers. - Reviewing various cases and...

Posted 2 months ago

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Director - Safety Writing GSK

10.0 - 18.0 years

0 Lacs

karnataka

On-site

Job Description: As the Director of Safety Writing at GSK, you will be leading the safety writing team to ensure the accurate, clear, and compliant preparation of Aggregate Reports and Risk Management Plans. Your role will involve a deep understanding of regulatory guidelines, effective leadership skills, and the ability to build a best-in-class capability to achieve organizational business goals related to safety writing. You will oversee the efficient preparation of high-quality safety writing deliverables that are strategically aligned and lead a global team of medical writers. Additionally, you will be responsible for optimizing internal and external resourcing, ensuring compliance, impl...

Posted 3 months ago

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Drug Safety Specialist Fidelity Health Services

3.0 - 7.0 years

0 Lacs

maharashtra

On-site

The ideal candidate for this position should have a qualification of B. Pharm / M. Pharm/ BAMS/ BHMS. The job is located in Mumbai and Pune, India. You should have a minimum of 3-4 years of experience in case processing/ safety writing and knowledge of SDEA management. It is essential to have experience in exchanging safety data / conducting reconciliations with business partners. Strong written and verbal communication / presentation skills are also required. Keeping updated with the latest technical / scientific developments related to PV is crucial for this role. As part of your responsibilities, you will need to initiate communications with internal stakeholders such as business teams an...

Posted 3 months ago

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