Job Purpose:

Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including 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, Risk Management Plan (RMP), Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs) as well as preparing document of comparison 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 signal detection and management (where applicable).

Generating Line Listings, creating drug lists/drug folders, performing regulatory submissions, tests electronic submissions gateways, and tracking compliance monitoring of submissions in accordance with client/international conventions

Responsible for preparing the narratives associated with the client’s/sponsor’s products from clinical trials for Clinical Study Reports (CSRs) or in order to support any health authority requests in accordance with regulatory and client’s/sponsor’s requirements.

Imparting trainings to the new starts during the induction sessions and the team as required.

Demonstrating document leadership: communicating content requirements, coordinating and conducting interdepartmental team review of draft and final documents, scheduling and leading/facilitating authoring team meetings to agree on expectations, evaluate progress on tasks, identifying issues and facilitating resolutions, managing/driving the timeline, and advance document development to approval

Striving to enhance client’s satisfaction based on feedback provided by the client

Helping in management of process related queries at user level.

Acting in the capacity of lead, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues.

Project management of contractual and financial aspects, as necessary with guidance from management.

Identifying areas of concern within the team and raising the issues with project manager

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

* Aggregate Reports

* Clinical Study Report Narratives

* Signal Detection and Management

* General Related Duties

Overall Summary of Experience Required:-

Post-graduates in life sciences with five years of experience in medical writing/safety signal management is essential.

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

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 negotiate on behalf of the department to ensure resources, timelines and expectations are aligned
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
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)
Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services.
Provides departmental expertise and perspectives to promote prospective business opportunities.
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