Pfizer Hiring Pharmaceutical Chemistry for Senior Associate Post
Pfizer, a renowned global pharmaceutical company, is now Hiring Pharmaceutical Chemistry candidates for Senior Associate Post. Interested candidates can check out the details below and Apply online
Job title: Sr. Associate-I, CDM
Job Location: Chennai, India
Job id: 4888461
Education Level: Professional in Pharmaceutical Chemistry or equivalent Regulatory knowledge
Job Category: Field Sales
JobType: Full Time
JOB SUMMARY
This role will work within a team whose main focus will be to interpret the regulatory data received across different geographies, functions, divisions and ensuring key activities and regulatory systems updates are completed whilst adhering to all policies, practices and procedures. Timeliness/ accuracy in the data entry and removal of workload associated with data entry from Regulatory Strategy teams will be key performance indicators for this role. These activities ensure data integrity to enable the organization to have visibility across all functions within a products lifecycle. It is essential that all systems are clearly and accurately updated within the timelines specified in the Standard Operating Procedures (SOP) or business process documentation to ensure regulatory compliance.
JOB RESPONSIBILITIES
Review and interpret the data provided by the PCO to establish the system / tools required
to be populated in line with current standard operating procedures or business process documentation, including systems and SOPs associated with the regulatory data scope.- Perform data entry and quality control tasks associated in all global regulatory systems impacted, including systems associated with the regulatory data scope.
- Review audit reports from the systems and resolve errors to ensure integrity of data
- Identifies issues and provides input into solutions
- Accountable for remediation efforts associated with their scope as part of SCC global rollout.
- Perform monthly PEARL compliance report review and complete remediation activities in close partnership with Regulatory strategist teams
- Adhering to quality control procedures and standards related to the systems or tools ensuring Regulatory Compliance
- Support global/local team members with data management workload when necessary to provide flexible support for the portfolio.
- Adhere to Pfizer compliance standards
- Act as Regulatory Data SME in regions supported
- Produce country/regional reports as required
- Support audit as part of regulatory data / system scope
- Contributes to the completion of moderately complex projects as needed
- Has strong knowledge/understanding of the principles and concepts of the discipline.
QUALIFICATIONS / SKILLS:
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
- Computer literacy in MS Word/Outlook/Excel/Adobe Acrobat.
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
- Functional and technical knowledge and skills to do the job at a high level of accomplishment
- Proven technical aptitude
- Quick learner with ability to multi-task
- Ability to work with accuracy and attention to detail
- Ability to work with autonomy and/or part of a team in a busy environment
- Demonstrated ability to work in a highly regulated environment
- Quality focus
- Customer orientation
- Analysis and solution of problems
- Effective communication
- English intermediate to advance (written and spoken)
- Proven ability to coach and mentor others
- Proven ability to oversee and QC others work
- Ability to effectively communication with Regulatory professionals in other countries
- Academic Degree: Professional in Pharmaceutical Chemistry or equivalent
Regulatory knowledge and experience (at least 3-5 years) - Demonstrated ability to work in a highly regulated environment
- Project Management Experience
Pfizer is now Hiring Pharmaceutical Chemistry candidates. Here are possible interview questions and answers for Senior Associate Post:
1. Question: Can you tell us about your experience with regulatory data management and compliance in a highly regulated environment?
Answer: In my previous role as a Regulatory Associate, I gained extensive experience in managing regulatory data and ensuring compliance with industry standards. I worked closely with various teams to interpret regulatory data and update systems accurately and within specified timelines. I also have a strong understanding of regulatory processes and quality control procedures associated with data management.
2. Question: How do you prioritize and manage your workload when dealing with multiple data entry tasks and deadlines?
Answer: When faced with multiple data entry tasks and deadlines, I prioritize my workload by assessing the urgency and impact of each task. I create a schedule or checklist to stay organized and ensure that I meet all deadlines. I also communicate and collaborate with my team members to distribute workload and provide support when necessary. This approach has helped me effectively manage my workload and deliver accurate and timely results.
3. Question: Could you share an example of a situation where you encountered an error in regulatory data and how you resolved it to maintain data integrity?
Answer: In a previous project, I came across an error in the regulatory data that could have potentially affected compliance. I immediately reported the error to the relevant stakeholders and investigated its root cause. I worked closely with the team responsible for the data entry and quality control to rectify the error and ensure data integrity. By implementing corrective measures and conducting thorough checks, we were able to resolve the error and prevent any compliance issues.
4. Question: How would you handle a situation where there are conflicting priorities from different regulatory divisions or geographies?
Answer: When faced with conflicting priorities from different regulatory divisions or geographies, I would first gather all the relevant information and assess the impact and urgency of each priority. I would then communicate with the stakeholders involved to understand their perspectives and requirements. With a collaborative approach, I would work towards finding a solution that balances the needs of all parties involved. This may involve negotiating timelines, reallocating resources, or seeking guidance from senior management to ensure the most critical priorities are addressed while maintaining compliance.
5. Question: Can you describe your experience in supporting audits related to regulatory data and systems?
Answer: Throughout my career, I have actively participated in audits related to regulatory data and systems. I have worked closely with auditors to provide the necessary documentation, demonstrate compliance with standard operating procedures, and address any queries or findings. I understand the importance of maintaining accurate and complete records for audits and have successfully supported multiple audits by ensuring data integrity, implementing corrective actions, and following up on recommendations for process improvements.
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