Aggregate Report Analyst Senior Associate

Pfizer; Chennai District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Pfizer in India is seeking a PSSR Aggregate Report Analyst to prepare post-marketing safety documents and regulatory submissions. The role involves coordinating with project teams to translate safety data into compliant analyses and reports, and ensuring timely delivery of high-quality documents.

The ideal candidate has a life sciences degree and 2+ years of relevant experience in safety or regulatory writing, with strong analytical, writing, and communication skills; familiarity with regulatory

Qualifications

• Able to execute routine analyses and interpret routine safety analyses with guidance from team members (analytic skills)
• Understands 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 under general supervision. (writing skills)

Responsibilities

• Communicate WWSs 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.
• Identify potential areas for process improvements and possible solutions and communicate these to line management or appropriate functional line.

Skills

Analytic skills

Regulatory knowledge

Writing skills

Education

Bachelor's Degree in life sciences

Advanced degree (MD/PhD/PharmD) preferred

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 Responsibilities

• Communicate WWSs 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.
• Identify potential areas for process improvements and possible solutions and communicate these to line management or appropriate functional line.

Education

• Bachelor's Degree in life sciences and 2+ 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 areasAdvanced degree preferred (MD, DVM, PharmD, or Masters/PhD in relevant field)

Experience and Attributes

• Able to execute routine analyses and interpret routine safety analyses with guidance from team members (analytic skills)
• Understands 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 under general supervision. (writing skills)
• Has basic 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 in standard situations. (analytic skills, and maybe interpersonal skills as well)

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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