SIRO Clinpharm Private limited is an end to end, drug development solutions provider to the global healthcare industry.Our subject expertise gives us an edge in clinical trial management, clinical data management, medical writing, biostatistics and statistical programming, and pharmacovigilance. With a successful track record of 20 years, SIRO Clinpharm works with most top global biopharma and medical device companies. Our therapeutic experience includes – but is not limited to – oncology, diabetes, cardiology, infectious diseases and the respiratory system. We offer flexible business models across service verticals based on client needs.
Emcure Hiring For DSRM Writer
Job description
- Authoring, Review, and Quality Checks of Drug Safety & Risk Management Regulatory Submission Documents (ie, DSUR, PSUR/PBRER, SUSAR LL, RMP, PADER, adhoc reports, etc.) & other documents in accordance with applicable regulatory requirements, SOPs, and timelines with high quality and minimal oversight for multiple clients.
- Effectively contribute and manage the assigned Drug Safety & Risk Management writing activities & build expertise across the different document types assigned through imparting medical/scientific/clinical knowledge
- Effective writing, project management/coordination, and optimal project utilization with maximum productivity per assigned workload and defined metrics
- Authoring, Review, and Quality Checks of subject Narratives for CSR Appendices and PADERs.
- Strict adherence to applicable processes and policies, including but not limited to applicable regulations, guidelines, policies, SOPs, WIs, process flows, templates, style guides, etc.
- Providing all kinds of support for new and existing business, working for team goals and objectives, flexibility, good attention to details, no conflicts.
- Support coaching & mentoring/ buddy program (MW Champ), on-demand trainings, prepare/ support training modules and conduct trainings, disseminate the learnings across teams
- Clear and consistent written and verbal communication with client and within team, prompt acknowledgement and response, assertiveness, follow meeting etiquettes.
- Quick adaptability and learning attitude, willingness to stretch and multi tasks; Proficiency in English and use of MS office (word, excel, powerpoint, outlook, etc.)
Qualification : M.Pharma,M.Sc,BHMS
Location : Hybrid – Hyderabad/ Secunderabad,Telangana, Mumbai (All Areas)
Kindly share your updated CV to krishnaveni.thevar@siroclinpharm.com
Also Read: Email Resume : Cipla Work From & Office Job Opportunity For Any Graduate
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