Jobs

Interviews
Job Alerts
Tools

Upskill and Grow with AI

Mock Interview Practice interviews in realistic simulations

Coding Practice Improve your coding skills with challenges

Certification Earn certifications to validate your skills

AI Learning Get trained with AI expert sessions

Career Path AI insights for smarter career decisions

AI Job Match Score AI-Powered Job Match Against Your Resume and Optimize Your Resume

Career Tools and Resources

Resume Builder Build Professional Resume with Ease

ATS Friendliness Check Check Resume Friendliness for Applicant Tracking Systems

Auto Apply Apply to hundreds of jobs on any platform effortlessly

Co-Pilot (Chrome Extension) Your AI Assistant for Seamless Browsing Efficiency

Interview Questions Streamline interviews with ready-to-use questions

Salaries Discover market-driven salary insights across skillsets and geographies

Companies Explore leading companies actively hiring talent
For Employers

Jobs

Interviews

Home
>
Jobs in Chennai
>
Pfizer
>
Aggregate Report Analyst Manager

Aggregate Report Analyst Manager

Pfizer

3 - 6 years

5 - 9 Lacs

Chennai

Posted:12 hours ago| Platform:

Apply

Skills Required

Interpersonal skills Reporting Analyst Risk assessment Pharma Patient care Life sciences Pharmacovigilance Management Risk management Analytics

Work Mode

Work from Office

Job Type

Full Time

Job Description

Position Purpose

The PSSR Aggregate Report Analyst creates documents pertaining to post-marketing safety data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. These documents include but are not limited to integrated analyses of safety data in support of aggregate reports (e. g. , Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, Safety Update Reports, Canadian Annual Reports, etc. ), responses to regulatory queries on safety topics, post-marketing safety assessments, and Risk Management Plans and relevant documents.
Accurately translate understanding of regulatory requirements and corporate policies governing documents for regulatory submission into execution of timely and compliant analyses and presentations of safety data and benefit-risk assessment in documents.
Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues.
Provide oversight for internal or external (contractor) co-authors when required for a particular project or assignment (e. g. , Canadian Annual Report).

Primary Responsibility

Communicate WWS s position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed.

Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations.
Drive the document strategies and messages in a collaborative way with relevant project team subject matter experts. Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
Deliver assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality.
If overseeing the work of or leading a team of other authors (internal or external), be accountable for timely delivery of high-quality, fit-for-purpose documents to the project team.
Produce documents in conjunction with external vendors. Review documents produced by vendors and help evaluate vendor performance.
Understand relationships and dependencies between documents and analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and ACOs.
Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents.
Develop and sustain constructive relationships within other Pfizer lines including country organizations.
If assigned by manager, serve as the WWS point of contact for all document issues for a given product or set of products.
Identify potential areas for process improvements and possible solutions and communicate these to line management or appropriate functional line.

Education:

Bachelors Degree in life sciences and 3+ years relevant medical experience such as, patient care, clinical trial experience / investigator, academic medicine, specialty training or pharmaceutical industry experience, ideally in safety, regulatory or clinical areas
Advanced degree preferred (MD, DVM, PharmD, or Master s/PhD in relevant field)

Experience and Attributes:

Able to execute routine analyses and interpret routine safety analyses with guidance from team members ( analytic skills)
Has comprehensive understanding of regulatory guidance as it pertains to presentation and communication of benefit/risk and pharmacovigilance ( regulatory knowledge)
Is able to synthesize analyses of aggregate or individual patient data into clearly written text with minimal supervision. (writing skills)
Has good understanding of medical concepts of the disease and the specific approach to treatment.
Makes decisions that require choosing between multiple options to resolve moderately complex problems, some of which deviate from standard situations. (analytic skills, and maybe interpersonal skills as well)

Medical

#LI-PFE

More Jobs at Pfizer

Assistant Associate- Manufacturing

Visakhapatnam, Andhra Pradesh

4 - 4 yrs

Salary: Not disclosed

Junior/Assistant Associate Manufacturing

Visakhapatnam

1 - 6 yrs

INR 3 - 8 Lacs

Healthcare Executive

Mumbai, Maharashtra, India

Experience: Not specified

Salary: Not disclosed

Healthcare Executive

Delhi

Experience: Not specified

Salary: Not disclosed

AMA

Hyderabad, Telangana, India

Experience: Not specified

Salary: Not disclosed

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.