Plmds Associate Ii

4 months ago

Chennai Tamil Nadu, India Pfizer Full time

Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

You will help us in preparation, publication, tracking and quality control of our submissions to the regulators in compliance with document management standards. You will be responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.

It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

The PLMDS Associate - Article 57 / IDMP role will support Pfizer in delivering the portfolio of one or more applicable regulatory obligations. The role will work across team/s whose focus will be to comply with data submission activity including XEVMPD and IDMP. This may include the interpretation of health authority guidelines, interpretation and transformation of regulatory data, data collection, enrichment, mapping, and submission, whilst adhering to all policies, practices, and procedures.
- Contribute to the completion of project milestones and organize own work to meet project task deadlines.
- Execute, through use of standards and tools, designated operational tasks or through the applicable Pfizer country office, conforming to regulatory submission milestones and applicable regulatory obligations.
- Promote quality as a best practice based on knowledge of regulatory requirements, departmental guidelines, and Quality Control (QC) experience.
- Support the regulatory activities associated with allocated new food supplements in development.
- Compile, verify accuracy, and sort regulatory license information for products identified for withdrawal.
- Communicate with internal team members about execution and strategy as needed
- Actively pursue training in technical and personal skills relevant to the Certificate Signing Request Coordinator role.

PLMDS Associate II- JD
- Has fundamental understanding of XEVMPD, IDMP and other structured data requirements, regulations and telematic projects (e.g., SPL, PQ CMC, IRIS, ePI, DADI, etc)
- Uses technical skills to ensure compliance with regulatory obligations including XEVMPD and IDMP
- Ability to partner with stakeholders across the organization to resolve queries and issues
- Demonstrates solid grasp in learning, development, and technology
- Contributes to the completion of project milestones, organizing own work to meet deadlines
- Work in a structured environment under direct supervision and use established procedures to perform assigned tasks
- Actively participates in internal and external partnership networks (team meetings, forums, etc.)
- Assist with data quality reviews to support business objectives (e.g., system data reviews, PSUSA/XEVMPD, and Annual Pharmacovigilance Fees)

**Qualifications**:
Must-Have
- Bachelor's Degree 2+ yrs of experience in XEVMPD/IDMP role
- Demonstrated experience
- Relevant experience in electronic submissions build within the Pharmaceutical Industry
- Demonstrated coordination of activities in a highly regulated environment
- Demonstrated experience working in a challenging customer service environment
- Knowledge of the drug development process
- In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and modern technology implementation
- Good knowledge of English, spoken and written

Nice-to-Have
- PMP Certification or similar
- Ability to work with large datasets, interpret data and draw insights to support data driven approaches, predict outcomes and measure effectiveness
- Knowledge of data analytics and visualization tools (e.g., Spotfire), etc.
- Demonstrated experience of influencing through data storytelling, with the ability to use data to inform on an idea, concept, or insight
- Able to identify and drive digital technology into all areas of a business. Further able to evolve the digital thinking by identifying connections of systems and data across the business

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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