Job Description
Key Accountabilities:
Note: The below statements describe the general nature and level of the work being performed and are
not an exhaustive list of all responsibilities required for the position. Responsibilities vary as applicable
Accountability Supporting Activities
Aggregate reports Preparing/updating/merging RMPs/Company Core-RMPs (CC-RMPs),
preparing a health authority response document along with RMS update
in accordance with client requirements/conventions and SOPs.
Managing scheduled and unscheduled aggregate reports including but
not limited Periodic Safety Update Reports (PSURs), Periodic Benefit
Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews
(ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum
Reports, United States Periodic Adverse Drug Experience Reports
(PADERs), Development Safety Update Reports (DSURs), Annual Risk-
Benefit Evaluation (ARBE) report Safety statements, Health Hazard
Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO),
Safety Evaluation Report (SER), Investigational New Drug Annual Report
(INDARs), comparison document between local and global labeling
document (if applicable)and checking of International Non-proprietary
names (INNs) for inclusion in a PSR as per client requirements and
conventions and SOPs
Conducting critical appraisal and systematic review of literature with a
focus on background epidemiology, specifically information on the
incidence, prevalence and risk factor in patient populations, for inclusion
in drug Safety Reports and RMPs
Providing input and developing literature search strategies for the
epidemiology section of safety reports
Applying epidemiological methods and calculations to data available in
literature to support the background rates of the issues under evaluation
for the safety reports
Generating Line Listings for submissions/ to identifying discrepancies and
ensuring resolution of the discrepancies
Revising document drafts based on the review comments from team
members to ensure inclusion of all relevant input.
Ensuring that all work is complete and of high quality prior to team or client
distribution. Confirm data consistency and integrity across the document.
Performing aggregate report compliance activities including quality review
to check the data/facts and internal consistency across various type of
aggregate reports including but not limited to PBRERs, Ad hocs, HHEs,
LJDs, tables, RMP, Pharmacovigilance System Master File (PSMF)
document (as applicable)
Distributing of final reports to the stakeholders including partners, affiliates
and submission to health authorities, according to the agreed timelines,
distribution lists and email templates (as required)
Job Description
TP-HR-WW-001-11
TP-BPM-WW-032-05 TP Effective Date: 18 May 20
Related to: SOP-BPM-WW-001 TP Related to: SOP-HR-WW-001
JD Version date: 01-Jul-2020 Page 3 of 4
Scheduling and coordinating meetings/ Drafting meeting agenda and
minutes/Tracking action items and soliciting follow-up for open issues
Clinical Study
Report Narratives
Coordinates and liaises with the members of Study Management Team
(SMT)/Study In-charge or equivalent, to discuss the narrative template
development process, narrative categories and review of the narratives
(as required)
Serves as primary client contact for narrative writing for an assigned
study, agreeing/negotiating deliverable timelines, and
addressing/resolving any narratives related issues (as required)
Prepares clear and accurate narratives based on Clinical Database and
Safety Database outputs provided by the client and ensures their
appropriate medical cohesiveness and assessment in accordance with
the client's and Parexel's conventions/guidelines and Standard Operating
Procedures
Performs quality checks on the drafted narratives as required
Ensures the work is complete and of high quality, including final quality
control checks, compilation and formatting.
Provides CSR narrative review support to the SMT where requested
Signal Detection and
Management
Perform signal detection review and analysis (qualitative and quantitative)
from various sources e.g. regulatory authority database, client database,
literatures, regulatory authority websites etc.
Responsible for the end-to-end signal management process (i.e. signal
tracking, signal assessment/data analysis, leading review meetings,
presenting, etc.) in collaboration with the GSO
Conduct/support signal detection and evaluation activities according to
SOPs and guidelines
General Maintaining a good working knowledge of the adverse event safety profile
of the assigned drugs, labeling documents, client's guidelines, procedures
and SOPs, and international drug safety regulations
Maintaining an awareness of global regulatory reporting obligations and
organizing workload to ensure compliance with internal and regulatory
timelines for the adverse event reporting
Maintaining a good working knowledge of the assigned Clinical studies for
narratives
Ensuring that all work is complete and of high-quality
Attending/conducting internal, drug safety and project specific training
sessions
Preparation for, participation in, and follow up on audits and inspections
Maintaining an awareness of the performance metrices measured by the
client and striving to remain within established limits
Delegating work as appropriate to Associate Medical Writer and Medical
Writer I
Striving to enhance client's satisfaction based on feedback provided by
the client
Imparting project specific trainings to the new starts as required.
Serving as the primary client contact, liaising and collaborating with the
relevant function at the client's end to facilitate the delivery of high-quality
work
Evaluating and incorporating reviewer comments in draft reports and
liaising with relevant contributors for resolution of comments
Job Description
TP-HR-WW-001-11
TP-BPM-WW-032-05 TP Effective Date: 18 May 20
Related to: SOP-BPM-WW-001 TP Related to: SOP-HR-WW-001
JD Version date: 01-Jul-2020 Page 4 of 4
Mentoring new recruits in the team, if required
Archiving the source documents and relevant emails as required
Responding to clients/customers in a timely manner
Participating in departmental or interdepartmental process improvement
and training initiatives (if required)
Skills:
Analytical and problem-solving skills
Excellent interpersonal skills
Excellent verbal / written communication skills
Excellent organizational and prioritization skills
Ability to work collaboratively and effectively in a team environment
Client focused approach to work
Ability to evaluate data and draw conclusions independently
A flexible attitude with respect to work assignments and new learning
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention
to detail
Ability to understand all necessary steps in a project, plan steps ahead, and identify critical paths.
Fluency in written and spoken English
Computer proficiency, IT skills, the expertise and an ability to work with web-based applications,
and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power
Point)
Capability to make concise, accurate and relevant synopses of medical text and data, and the ability
to write unambiguous medical text
Typing and transcription accuracy
Awareness of global culture and willingness to work in a matrix environment
Knowledge And Experience:
Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field.
Good knowledge of medical terminologies
Education:
Science/Medicine degree: The minimum qualification required would be a university degree in life
Sciences/ Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology,
Biophysics etc.)
A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves
patient exposure in hospital-based environment, would be an advantage
