Job Description

Essential Duties and Responsibilities:
As Medical Writer (Aggregate Safety Report):

• Function as primary point of contact for each group of therapeutic areas.
• Lead/Co Lead cross functional teams contributing to periodic safety reports in accordance with Global Pharmacovigilance and Risk Management (GPRM) business rules, standard operating procedures (SOPs), and global regulatory requirements.
• Support roles involved in creation of Aggregate Safety Reports (ASRs) (i.e. PSURs, PADER, DSURs, PBRER’s, Addendum to Clinical Overview’s, Addendum to PSUR’s, Summary Bridging Report’s and RMP Updates).
• Review aggregate safety data from the database and generate line listings (LL) and summary tabulations (ST) and include the LL & ST in the appropriate template.
• Compile the safety data into the relevant sections of periodic reports such as PBRER, PSUR, AdCO, PADER, and DSUR according to the client.
• Reviews and identify the literature that is selected for inclusion in the regulatory document that may lead to the signal detection.
• Ensure that narrative writing/safety report drafting, follow-up activities and all documentation are conducted per client approved project SOP, WI, convention and workflow in collaboration with quality assurance.
• Plan, organize, and manage daily work to meet service level timelines and deliverables.
• Work with the Aggregate Reporting lead to escalate issues or tasks outside the normal scope of work.
• Provide word and PDF versions of the final signed documents to the client.
• Participate in internal and external audits and inspections by clients and health authorities.
• Ensure adequate and appropriate training and training documentation.
• Cross check RMPs as required to draft aggregate reports
• Ensure appropriate and adequate resource allocation and back-up roles for project continuity and timely delivery.
• Quality delivery through a rigorous metrics-based approach.
• Ensure timeline are being met.
• Perform any other drug safety related activities as assigned

As Quality Reviewer:

• Quality review of the Regulatory documents before they are sent to the client for review
• Perform data quality check on full draft safety reports and narrative batches
• Ensure all steps for aggregate report process is appropriately documented.
• Document all QC findings from the draft report review and notify, in writing, to medical writer/Medical reviewer
• Cross check RMPs as required to draft aggregate reports
• Notify QC identified issues that impact report to the PM
• Document and track all the QC review and findings and ensure resolution by PM
• Document and track resolution to QC review and findings
• Ensure all the steps of aggregate report process is appropriately documented

Secondary Responsibilities:
Maintain quality service and departmental standards by:

• Reading, understanding, and adhering to organizational standard operating procedures (SOPs)

• Assisting in establishing and enforcing departmental standards

Contribute to team effort by:

• Working with internal staff to resolve issues
• Exploring new opportunities to add value to organization and departmental processes
• Helping others to achieve results
• Performing other duties as assigned

Specialized knowledge and skills:

• Basic competence with medical and therapeutic terminology.
• Ability to work independently but guided by documented procedures, with appropriate support.
• Able to work effectively as part of a team.
• Understanding of patient safety regulatory obligations.
• Should be familiar with regulatory &pharmacovigilance guidelines.
• Should be familiar with pharmacovigilance terminology.
• Excellent attention to detail.
• Ability to deliver within established timelines.
• Fluency in English and excellent comprehension.
• Computer literate.
• Relevant product and industry knowledge.
• Experience with relevant software applications.

Communication skills:

• Requires a proactive approach and excellent written/oral communication and interpersonal skills.
• Strong interpersonal skills required to interact with clients, management, and peers effectively.
• Effective cross‑department communication.
• Ability to document and communicate problem/resolution and information/action plans.

Desired technical skills:

• Person should be familiar with MS Office Tools.
• Safety database knowledge.

Other skills:
The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines.
Compliance:
Awareness of organizational policies & procedures governing his/her job responsibilities. Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures.
Working Conditions: Normal office environment.
Hours:
Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed.
EEO Statement
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.
Collaboration, Continuous Learning, Critical Thinking, Organizational Awareness, Results Orientation, Service Orientation