MSERM Writer

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.

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.

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).

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).