Medical Reviewer Icsr Process

Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

**Job Description**:
The drug safety physician should be able to process and perform medical review all types of Individual case safety reports (ICSR) like health authority reports, clinical trails, post marketing spontaneous, Clinical Literature, Clinical study reports/Solicited reports, by writing an expert Pharmacovigilance comment. 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 Include:

- Provide timely support for medical assessment of initial case triage and also assist in reviewing medical information queries pertaining to ICSRs.
- Able to properly rank event based on seriousness criteria, labeling and causality assessment
- Causality assessment for all events based on WHO algorithm and ICH guidelines also taking into consideration vendor conventions specific for different therapeutics areas.
- Able to give proper labeling assessment for adverse events with reference to different types of product safety profiles like USPI, Canadian Product Monograph, SmPC, CDS, PIL, PI, RSI.
- Use of global safety database (ARISg, ARGUS) in accordance with company SOPs and regulatory requirements and draft a medical expert or pharmacovigilance comment.
- Medical review of all codings done by using MedDRA (latest version) with respect to adverse events, indications, laboratory data, medical history or surgical procedures.
- Should be able to resolve and also raise any medically significant follow up Query or medical relevant Query for respective ICSRs to designated vendor/client.
- Training new associates in pharmacovigilance processes in medical relevant topics like causality/labeling/Medical assessment/Medical review as and when required.
- Should also help Vendor in resolving any regulatory medical queries or findings pertaining to ICSR reports
- Must be able to review, identify potential signals from ICSRs and provide adequate expertise in management of that signal by intimating the vendor.
- 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.

**Qualifications**:

- Required: Valid Medical degree (MBBS, BDS with experience) from a centrally recognized University/college (MCI recognized)
- Preferred: 1-2 years of experience in related field of expertise.
- Preferred: Database experience of ARISg/ARGUS.
- Preferred: Experience in handling Medical queries/trainings in PV.
- Preferred: Experience in ICSR process with expert knowledge on MedDRA codings, IME list, CTCAE table.
- 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.
- Strong organization and prioritization skills; able to multitask.
- Strong decision making skills.
- Strong problem solving skills.
- 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.

Additional Information

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.