Safety Surveillance Associate

2 months ago

Chennai, India Pfizer Full time

Why Patients Need You

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will Achieve

You will be relied on by the company to monitor its drug, biologics and medical devices surveillance program. This will include intake, evaluation and processing of the adverse reports received. You will support the clinical trial as well as the post marketing activities.

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 teaming environment for your colleagues.

It is your dedication and hard work that will make it possible for Pfizer’s customers and patients to receive the medicines they need, when they need them.

How You Will Achieve It
- Contribute to completion of project milestones and organize own work to meet project task deadlines.
- Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission.
- Support Worldwide Strategy and Regulatory teams by providing analyses of post-marketing safety data, reviews of the medical literature, and similar related activities.
- Review case criteria to determine the appropriate workflow for case processing.
- Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.
- Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately.
- Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly.
- Review case criteria to determine the appropriate workflow for case processing.
- Write and edit the case narrative.
- Generate reports, ensuring adherence to regulatory compliance timelines.
- Determine appropriate case follow-up, requesting follow-up letters when appropriate.
- Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.
- Develop and maintain expertise and knowledge of all products within the Pfizer portfolio; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database.

**Qualifications**:
Must-Have
- Bachelor's Degree (Health care professional)

Nice-to-Have
- Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement.
- Demonstrated computer literacy, particularly in the use and management of relational databases.
- Ability to achieve personal objectives while meeting departmental standards of performance.
- Ability to work under supervision in a matrix organization.
- Excellent oral and written communication skills.
- Fluency in spoken and written English; knowledge of additional language(s) an advantage.
- Experience and skill with medical writing an advantage.

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.

Medical

LI-PFE

  • Safety Surveillance Associate

    1 month ago

    Chennai, India Pfizer Full time

    Organizational Relationship(s) including to whom the position reports (JD Job Title): Case Processing Team Lead Position Purpose Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements. Primary Responsibilities - Identify and select routine cases...

  • Safety Surveillance Associate

    2 months ago

    Chennai, Tamil Nadu, India Pfizer Full time

    Organizational Relationship(s) including to whom the position reports (JD Job Title): - Case Processing Team Lead - Position Purpose - Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements.- Primary Responsibilities - Identify and select routine...

  • Associate - Safety Security and Loss Prevention

    4 weeks ago

    chennai, India Mahindra Logistics Full time

    Duties/Responsibilities but notlimited to :- 1. Identifies,recommends, and implementssystems to minimize loss, money, orcompany assets. 2. Audits andinvestigates sources of knownlosses. Develop Monitoring ofinventory to identify theft orshortages. 3. Investigatessuspicious customer and/oremployee activity. Conductsperiodic testing of alarm( fire exit)and...

  • Lead Safety Management System

    2 months ago

    Chennai, India The ePlane Company Full time

    About the CompanyUbifly Technologies wants to make transportation clean, affordable, and more importantly, extremelyfast. We are pushing the boundaries of what is possible in the air by developing electric flying taxis tomake urban aerial mobility a reality. In pursuit of this goal, we have developed and tested 2 differentclasses of drone catering to cargo...

  • Lead Safety Management System

    1 month ago

    chennai, India The ePlane Company Full time

    About the Company Ubifly Technologies wants to make transportation clean, affordable, and more importantly, extremelyfast. We are pushing the boundaries of what is possible in the air by developing electric flying taxis tomake urban aerial mobility a reality. In pursuit of this goal, we have developed and tested 2 differentclasses of drone catering to cargo...

  • Lead Safety Management System

    2 weeks ago

    Chennai, India The ePlane Company Full time

    About the CompanyUbifly Technologies wants to make transportation clean, affordable, and more importantly, extremelyfast. We are pushing the boundaries of what is possible in the air by developing electric flying taxis tomake urban aerial mobility a reality. In pursuit of this goal, we have developed and tested 2 differentclasses of drone catering to cargo...

  • Senior Associate, Compliance

    3 weeks ago

    Chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full time

    Bring your ideas. Make history.  BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of banks” - % of the world’s top...

  • Associate, Compliance

    3 hours ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    **Overview** **Associate - II - Grade H - Trade Surveillance** **Bring your ideas. Make history.** BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or...

  • Safety Officer

    2 months ago

    Ennore, Chennai, Tamil Nadu, India Vensol Automation Full time

    **Safety Officer Requirements**: - A bachelor’s degree or an associate degree. - Valid competency certificates. - Strong communication skills. - Minimum of 1 year experience in this position. - Proficient in all Microsoft Applications. - **Safety Officer Responsibilities**: - Compile safety programs. - Practice safe working techniques. - Implement and...

  • Machine Safety Consultant

    2 months ago

    Chennai, India OMRON Full time

    Permanent About Founded in 1933, OMRON has come a long way since and has evolved to become an organization committed to creating new social values. Today, In the APAC region, OMRON has a strong presence in , , and . Let’s begin the exciting journey of together with About OMRON Industrial Automation Come join our Industrial Join OMRON Talent Don't find this...

  • Machine Safety Consultant

    2 weeks ago

    Chennai, India OMRON Full time

    Permanent About Founded in 1933, OMRON has come a long way since and has evolved to become an organization committed to creating new social values. Today, In the APAC region, OMRON has a strong presence in , , and . Let’s begin the exciting journey of together with About OMRON Industrial Automation Come join our Industrial Join OMRON Talent Don't find this...

  • Machine Safety Consultant

    1 month ago

    chennai, India OMRON Full time

    Permanent About Founded in 1933, OMRON has come a long way since and has evolved to become an organization committed to creating new social values. Today, In the APAC region, OMRON has a strong presence in , , and . Let’s begin the exciting journey of together with About OMRON Industrial Automation Come join our Industrial Join OMRON Talent Don't find...

  • Machine Safety Consultant

    2 weeks ago

    chennai, India OMRON Full time

    Permanent About Founded in 1933, OMRON has come a long way since and has evolved to become an organization committed to creating new social values. Today, In the APAC region, OMRON has a strong presence in , , and . Let’s begin the exciting journey of together with About OMRON Industrial Automation Come join our Industrial Join OMRON Talent Don't find...

  • Security Officer

    2 months ago

    Chennai, India OM Logistics Ltd Full time

    Ensure the security, safety and well-being of all personnel, visitors and the premises. - Immediately respond to emergencies to provide necessary assistance to employees and customers. - Check surveillance cameras periodically to identify disruptions or unlawful acts. - Submit reports of daily surveillance activity and important occurrences. - Prevent losses...

  • Security Officer

    4 days ago

    Chennai, India Westart Communications India Pvt Ltd Full time

    We are looking for a competent **Security Officer** to undertake the surveillance of our premises and protection of our staff and visitors. You will be responsible for detecting any suspicious behavior and preventing vandalism, thefts or other criminal behavior. The goal is to help the company in maintaining excellent working conditions by keeping our...

  • Associate, Compliance

    3 days ago

    Chennai, India BNY Mellon Full time

    Overview Grade H - Senior Analyst - Trade Surveillance QA Overview Of BNY Mellon BNY Mellon is a global financial services company focused on helping clients manage their financial assets, operating in 35 countries and serving in more than 100 markets. BNY Mellon is a leading provider of financial services for institutions, corporations and high-net-worth...

  • Technical Safety Lead – KNPC project

    3 days ago

    Chennai, India Saaki Argus & Averil Consulting Full time

    Our client is an leading provider of power transmission solutions in India and abroad. We offer end-to-end services from design, engineering, procurement, construction, commissioning, operation and maintenance of power transmission infrastructure. We have executed projects in various terrains and challenging environments, including high altitude, desert,...

  • Safety Officer

    1 week ago

    Gummidipoondi, Chennai, Tamil Nadu, India MITHRA Full time

    **Safety Officer (EHS) for Recycle Industry for Perundurai and Chennai Unit** **Minimum 5 years experience** **Lanugage : English, Tamil, Hindi** **Job Summary**: Responsible for Setting up the Safety Plan, Safety Objectives for the segment and getting approval from top management. Capable to lead as Management Representative Ensuring the System...

  • Technical Safety Lead – KNPC project

    2 months ago

    Chennai, India Saaki Argus & Averil Consulting Full time

    Our client is an leading provider of power transmission solutions in India and abroad. We offer end-to-end services from design, engineering, procurement, construction, commissioning, operation and maintenance of power transmission infrastructure. We have executed projects in various terrains and challenging environments, including high altitude, desert,...

  • Technical Safety Lead – KNPC project

    2 weeks ago

    Chennai, India Saaki Argus & Averil Consulting Full time

    Our client is an leading provider of power transmission solutions in India and abroad. We offer end-to-end services from design, engineering, procurement, construction, commissioning, operation and maintenance of power transmission infrastructure. We have executed projects in various terrains and challenging environments, including high altitude, desert,...