Pharmacovigilance Services Specialist-Pharmacovigilance

Skill required: Pharmacovigilance - Pharmacovigilance & Drug Safety Surveillance

Designation: Senior Drug Safety Scientist

Job Location: Bengaluru

Qualifications: Bachelor of Pharmacy/BSc/MBBS

Years of Experience: 7 to 11 years

You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. You will be part of a dynamic Pharmacovigilance team with array of capabilities ranging from detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem following Good Pharmacovigilance Practice (GVP) per client SOPs and applicable global regulatory requirements (Individual Case Safety Reports) to working on various aspects of Aggregate reports such as planning, authoring, reviewing and publishing of PBRER, PSUR, DSUR, PADER, Addendum to clinical overview (AdCO), Risk Management Plan (RMP), Signal detection and validation reports (SDVR), Cosmetovigilance Safety Reports (CoSR). The Pharmacovigilance team is also responsible for authoring and reviewing clinical documents such Protocols and amendment, Investigator Brochure, Clinical Study Reports (CSR), Synoptic/Abbreviated CSR, Safety Narratives, Clinical Overview/abbreviated Clinical Overview. Responsible for identification and creation of cases in the Global Safety database.

Ability to work well in a team
Adaptable and flexible
Agility for quick learning
Commitment to quality
Detail orientation
Educational and Experience Requirements:
Minimum of Bachelor s degree in Health Sciences; Bachelor s Degree in Life Science with relevant experience.
Entry level Role
Good knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug
Technology skills: experience with MS office
Knowledge of safety database and automation technology as applicable for the role
Good Communication Skills
Analytical Ability
Strong English Language proficiency (Reading and Writing) and Good English Language proficiency (Listening and Speaking)
Review and reconciliation of data between the Patient Safety and Clinical databases
To make requested changes in the safety database, if required based on documentation
To request for documentation and provide justifications or rationale if required
To make sure that the data between the Patient Safety and Clinical databases are correct and completed on a timely manner
To record all comments and actions on the reconciliation sheet as sent by the data manager
Perform the download of PV obligation and MLM cases from EMA website
Perform EV cases narrative downloads per the process agreed with Client
Complete and document a check of all Cases not to be databased on a periodic basis and share the results of any errors and if required, associated action plans with Client.
Confirm compliance to the SOPs and guidelines for all book-in activities are performed.
To participate in audits or inspections.
Open to get trained and moved across roles based on business requirement.
Authoring of process documents

Responsibilities/Authorities
Access the designated email box(es) and case intake queues in the system (e.g., LAM intake or E2B intake) as agreed by both Parties to retrieve new incoming safety information or follow-up correspondence for existing cases per Client sops
Contact the relevant CO to obtain an English translation, if applicable.
Determine whether the information is eligible for databasing per client procedures
Ensure a duplicate check against the Global Safety Database is conducted in accordance with client SOPs for all ICSRs to determine whether there is an existing Case file.
Ensure that all identified duplicate ICSRs and Source Documentation are electronically stored and appropriately cross-referenced with the original Case;
Create an electronic Case report file for each new Case, including a cross- reference for each duplicate Case identified in the Global Safety Database;
Send an acknowledgment of receipt (including the Case number) in respect of any safety information accessed by Accenture pursuant to the Source Document sender;
Archival of all source documents, clarifications, communications and reports in the Global Safety database
Review non-case information received via e-mails, in-coming E2B and LAM and respond appropriately/acknowledge to the sender.
Ensure events are identified from Source documents and entered within timeframe defined in agreed TAT SLA s to ensure correct screening and triage of Cases.
Perform medical coding for ICSRs using MedDRA
Screen the Cases appropriately i.e., Seriousness assessment, and other relevant triaging criteria for further processing in the workflow according to Client procedures and determine Day 0 in order to meet the regulatory due date of ICSRs, the TAT SLAs and KPIs.
Ensure not to disclose information identifying the patient or trial subject associated with an Adverse Event; Remove/blind patient s and reporter s personal information from the ICSRs;
Inform the applicable manufacturing Site about a Product Complaint. Where a Product Complaint is associated with an Adverse Event or safety hazard, the results of any investigation shall be included in a follow-up ICSR;
Complete reconciliation of mailbox activities as needed;