Job –Drug Safety Physician/Senior Drug Safety Physician/Principal Drug Safety Physician, Location – anywhere in India/or Home based.

The incredible growth at Parexel continues! Our Global Safety Services team is still growing! We’re currently looking for an experienced Drug Safety Physician to join our team in India.

Our ideal candidate should have MBBS or a MD degree with 2+ years of aggregate writing experience.

Job location : Hyderabad/Bangalore/Chandigarh/Mohali/Delhi/Mumbai/Decentralised

If interested pls share your Cv’s with Subramanyam.Turga@Parexel.com

Job Purpose:

• Provide medical review, analysis and guidance during the case handling and reporting cycle of

Adverse Event and Adverse Reaction reports received for investigational and marketed products

• Signal detection/analysis/evaluation and ongoing safety surveillance activities

• Provide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical

aspects of drug safety

• Provide medical advice/input for narratives written for Clinical Study Reports (CSRs)

• Provide medical, safety input and review of all required safety reports, such as- but not limited to Periodic Safety Update Reports (PSURs)/ Periodic Benefit Risk Assessment Reports (PBRERs)/

Periodic Adverse Drug Experience Reports (PADERS), Risk Management Plans (RMPs), Benefit

Risk Assessment, Safety Evaluation Reports (SERs), Clinical Overview (COs), clinical Expert

Statement, Investigator notification letters

• Function as pharmacovigilance representative/safety scientist.

Case report Medical review:

• Performing medical review of cases according to client Standard Operating

Procedures (SOPs) and liaising with the client, as required

• Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment

and assessing company causality

• Assessing seriousness and expectedness of reported events

• Providing medical advice to case processing team

Periodic reports:

• Review and authoring of aggregate reports for medical context and

consistency in accordance with client requirements and SOPs

• Providing medical advice to case processors for authoring of sections

Literature review • Review of literature for product safety assessment and potential safety

issues

CSR Narratives:

• Performing medical review of CSR narratives according to the client’s

guidelines and SOPs

Safety Scientist:

• Contribute to Pharmacovigilance and Risk Management planning for

designated products by preparation of safety surveillance strategy and

highlighting and tracking potential issues

• Support the preparation and maintenance of Risk Management plans

• Prepare and review periodic safety reports (PBRER / PSUR, DSUR, EU

renewal, Health Hazard Assessments and other Annual Safety/addendum

reports) in accordance with regulatory requirements and standard operating

procedures

• Support the preparation and maintenance of safety sections of the Company

Core Data Sheet, local labels and Development Core Safety Information

(DSCI)

• Coordinate safety activities between PDS and internal and external partners

• Conduct/support signal detection and evaluation according to SOPs and

guidelines

• Prepare safety assessments, drug safety reports, as necessary, for potential

signals or issues (product quality)

• Perform review and summarization of literature citations including

epidemiology background research

• Provide safety content review of clinical protocols, study reports,

Investigators Brochure and other related documents to ensure alignment

with CDP

• Contribute to regulatory agency submissions (IND applications, NDAs,

MAA’s, Variations, Renewals) by reviewing safety data and preparing

relevant sections of the filing documents and submission packages

• Participate in or provide input for Drug Safety Monitoring Boards or

independent monitoring committee meetings, as applicable

Skills:

• Excellent interpersonal, verbal and written communication skills

• Computer proficiency, an ability to work with web-based applications and familiarity with the

Windows operating system

• Client focused approach to work

• A flexible attitude with respect to work assignments and new learnings

• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention

to detail

• Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is

essential

• Willingness to work in a matrix environment and to value the importance of teamwork

• Strong knowledge of international drug regulation including GCP, GVP

Knowledge and Experience:

Good knowledge of medical terminology.

Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred.

Education:

Graduation/Post Graduation in Medicine. (MBBS or MD)

Apply through this Link