Auftragsdetails

Detailed Description

Provide expert medical safety analysis for periodic safety aggregate reports (e.g. DSUR, PSUR/PBRER, ACO, RMP, PADER, bridging reports, Signal reports, Literature articles, Health authority requests/queries and other relevant aggregate reports for pharmaceutical products and biologics/biosimilars. 

Maintain distinctive quality and commitment as the operating philosophy in carrying out all processes. Continually seek out ways to enhance medical expertise in team both internally and externally.

Essential Functions:

• Provide medical safety expert opinion for Signal detection process and risk management activities. Must be able to assess and identify safety risks and potential signals in safety report or from designated RSI of suspect product.
• Provide Medical review of scientific Literature articles/abstracts along with expert or company comment
• Must be able to perform accurate labeling assessment wherever required for periodic safety reports
• Must be able to handle all medical relevant queries and address medical related issues from health authority queries/Vendor queries related to aggregate reports or Signal detection reports.
• Must regularly co ordinate with peer medical reviewers and also with vendor medical reviewers in assessing expert outcome or opinion for all Safety reports.
• Develop training materials, conduct training presentations and on-the-job-training for medical relevant information, topics to team and pharmacovigilance staff
• Would be an active part of any vendor related AUDITs, safety committee meetings and be responsible for any medical review relevant activities.
• Should maintain all medical relevant trackers /Minutes of meetings/training records on a real time basis.
• Other duties as assigned by the designated reporting manager.

Necessary Skills and Abilities:

• Proficient computer knowledge and computer keyboarding skills.
• Proficient with Microsoft Office Suite (Outlook, Word, Excel).
• Excellent Clinical and diagnostic skills
• Strong verbal, written and interpersonal communication skills.
• Strong medical assessment skill
• Excellent attention to detail.
• Able to work independently and collaboratively in a multidisciplinary team.
• Flexibility to adapt and meet fluctuating business priorities.
• Able to occasionally work extended and/or flexible schedule to meet client requirements.

Educational Requirements:

• Required: Valid Medical degree (MBBS)from a centrally recognized University/college (MCI recognized), Additional Specialization or diploma would be more preferred.

Experience Requirements:

• Preferred:1-2 years of experience in related field of expertise.
• Preferred: Database experience of ARISg/ARGUS.
• Preferred: Experience in ICSR process, Literature assessment, Aggregate reports (PBRER/PSUR//PADER/ACO), literature review,  Signal Detection reports

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.