Associate Director, Safety Medical Writing

Parexel

8 years

0 Lacs

Serilingampalli Telangana India

Posted:6 days ago| Platform:

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Skills Required

writing vigilance strategies compliance regulations reporting portfolio mdr management reports evaluation data combination training development risk analytics signal analysis planning leadership

Work Mode

On-site

Job Type

Full Time

Job Description

Job Description Experienced leader to oversee Medical Device Vigilance and Safety services. This role will be responsible for developing and implementing pre- and post-market surveillance (PMS) strategies, ensuring compliance with global regulations, and managing safety reporting for our medical device portfolio. Key Responsibilities Develop and implement medical device vigilance strategies aligned with regulatory requirements Ensure compliance with global regulations for medical devices, including EU MDR, FDA, and other market requirements Overall management of individual case safety reports (ICSRs) and medical device reports (MDRs) / post-market surveillance activities Direct preparation and review of Periodic safety update reports (PSURs), Clinical evaluation reports (CERs) and other regulatory submissions Lead discussions with notified bodies and regulatory authorities on safety data for medical devices / drug-device combination products, as applicable Manage a unit of medical device safety professionals, including implementing training programs Collaborate with cross-functional teams (Clinical Affairs, Quality Assurance, Regulatory Affairs) on safety strategies and product development Oversee risk management plans and benefit-risk assessments for medical devices Leverage data analytics for signal detection and trend analysis in medical device safety Contribute to long-term strategic planning for device safety activities Qualifications Advanced degree in Life Sciences, Pharmacy, Medicine, Medical devices or related field Minimum 8 years of experience in PMS / medical device vigilance, with at least 5 years in a leadership role Extensive knowledge of global medical device regulations, particularly EU MDR and FDA requirements Strong understanding of medical device vigilance processes and best practices Show more Show less