Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Senior Executive
• Day to day provision of general assistance to Strategists in the compilation of regulatory dossiers, coordination of marketing applications and responding to regulatory questions received from health authorities, as well as compilations of responses to queries that can serve multiple purposes
• Support for use of regulatory systems and managing documentation and information, including setting up standard formats or reports for recurring requests and status updates as needed.
• Maintain Regulatory Product profile documents by updating as requested by strategist when key milestones occur. Including status of product indications supplement status per AG settlement
• Provide targeted documentation searches in GDMS in support of responding to Health Authority queries and/or internal queries (such as AG settlement information search or searches to support medical information responses)
• Support for harmonization of Core Data Sheet (CDS) documents (multiple CDS per product) by preparing label comparison documents
• Complete data entry for PEARL updates as needed based on email template from PCOs
• Prepare and manage viewpoint items for planned submissions as needed
• Maintain tracking report for upcoming and pending approval submissions to facilitate communications with downstream team members such as Ad/Promo Regulatory, Commercial and PGS
• Prepare draft meeting notes and action item lists for Labeling and Rapid Response Team (RRT) meetings as needed
• Education: Post Graduate in Pharmacy or Science.
• Experience : Minimum 2 years of experience
• Skills: Required – excellent written, listening and verbal communication skills, ability to problem solve, technical aptitude ability to quickly learn and use new software, regulations and quality standards, attention to detail, ability to work independently with appropriate level of supervision, experience in customer service environment, aptitude in project management and logistics
• Knowledge of regulatory processes and documents, knowledge of therapeutic areas
• Thinks strategically with good project management skills
Qualification : M.Pharm, M.Sc
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
ID : 4788975
End Date : 15th August, 2020
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