Safety Writer Ii

2 weeks ago

Bengaluru, Karnataka, India Thermo Fisher Scientific Full time

Summarized Purpose:
Responsible for the planning, coordination and delivery of safety writing services for multiple clinical trial and/or marketed product projects. Performs day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines.

Activities include but are not limited to delivery of safety writing deliverables ranging from low to medium complexity through achievement of the following tasks:
project management, data review, authoring, and quality review. May also support authoring of higher complexity deliverables.

Effectively collaborates with various parties, including but not limited to:
PVG project team members, wider PPD/Evidera project team members, client contacts and third party vendors.

Essential function:
Conducts data review, authoring, and quality review tasks on, and project
manages a wide range of clinical trial and marketed product safety writing
deliverables. These include low complexity (e.g. line listing reports; Periodic
Adverse [Drug] Experience Reports (PA[D]ERs)) and moderate complexity (e.g.
Development Safety Update Reports (DSURs), Periodic Safety Update Reports
(PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), development Risk
Management Plans (dRMPs)) deliverables.
May additionally support authoring of high complexity (Risk Management Plans
(RMPs), marketing authorisation dossier content, customized safety writing
deliverables and regulatory authority assessment report responses) deliverables
under supervision from more senior staff.
Uses multiple company and client systems. Interacts with project team members
and clients.
Operates in a lead capacity, serving as the primary point of contact for assigned
safety writing deliverables. Provides assistance in the development of program
and departmental procedural documents. Mentors less experienced staff.
Ensures that assigned safety writing and project management tasks are
conducted in accordance with company policies and procedures, contractual
agreements and applicable regulations.
Reviews regulatory/pharmacovigilance publications and information sources to
keep updated on current regulations, practices and procedures.
Participates in departmental initiatives
Performs routine project implementation and coordination activities for assigned
safety writing projects, including leading kick-off meetings, managing
communications and data requests, participating in client meetings, audits and
inspections, and reviewing metrics and budgets.

Job Complexity:
Works on problems of diverse scope where analysis of data requires evaluation of
identifiable factors.

Job Knowledge:
A seasoned, experienced professional with a full understanding of area of
specialization; resolves a wide range of issues in creative ways. This job is the fully
qualified, career-oriented, journey-level position.

Supervision Received:
Normally receives little instruction on day-to-day work, general instructions on new
assignments. Demonstrates good judgment in selecting methods and techniques for
obtaining solutions.

Business Relationships:
Represents the department as a prime contact on projects. Interacts with internal
and external personnel on significant matters often requiring coordination between
functional areas. Networks with senior internal and external personnel in own area
of expertise.

Qualifications:

Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training
and/or directly related experience, will be considered sufficient for an individual to meet the
requirements of the role.

Knowledge, Skills and Abilities:
Comprehensive knowledge and experience of ICH and US aggregate safety reporting formats relating to clinical trials and/or marketed products
Thorough attention to detail; strong data interpretation and medical-scientific writing skills
Strong critical thinking and problem solving skills with ability to evaluate and escalate appropriately
Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
Skilled at complex project administration including budget activities and forecasting
Strong oral and written English language communication skills, including paraphrasing skills
Solid computer skills with the ability to work within multiple systems; proficient in use of Microsoft
Office products (including Outlook, Word, and Excel)
In-depth understanding of the global regulatory requirements pertaining to pharmacovigilance and
the importance of and compliance with procedural documents and regulations
Ability to maintain a positive and professional demeanor in challenging circumstances
Ability to work effectively within a team to attain a shared goal

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