Менеджер по развитию и обучению медицинской команды (Excellence Medical Manager)

Описание

S h y r y n Im a s h o v a
M edical Affairs | R egulatory Affairs | Pharm acovigilance | C linical Pharm acology Alm aty shirin_forever@ m ail.ru Shyrynlm ashova@ gm ail.com
+7 701 401 9448
P R O F E S S IO N A L P R O F IL E
Senior M edical Affairs and R egulatory professional w ith 15+ years of experience across
pharm aceutical industry, regulatory authority, pharm acovigilance, and clinical pharm acology.
Proven expertise in: ● M edical Affairs strategy and scientific engagem ent ● R egulatory Affairs across Kazakhstan and EAEU ● Pharm acovigilance system s and G VP com pliance ● C N S / N europsychiatry therapeutic area ● R egistration lifecycle m anagem ent ● C ross-functional m edical leadership ● Scientific com m unication and KO L partnership ● C linical and regulatory evaluation of m edicinal products Form er regulatory expert at the N ational C enter for Expertise of M edicines w ith extensive
experience in dossier assessm ent, pharm acovigilance oversight, and EAEU harm onization
activities.
C urrently serving as M edical Advisor / D eputy Q PPV at G edeon R ichter Kazakhstan supporting neuroscience and psychiatry portfolio.
C O R E E X P E R T IS E
M edical Affairs • R egulatory Affairs • Pharm acovigilance • EAEU R egistration
Lifecycle M anagem ent • M edical Strategy • KO L Engagem ent • Scientific Exchange
R isk M anagem ent Plans (R M P) • PSU R /PBR ER • G VP C om pliance • M edical W riting
C linical R esearch Support • R egulatory Intelligence • C ross-functional Leadership
G M P • G C P • G LP • G VP

P R O F E S S IO N A L E X P E R IE N C E
G e d e o n R ic h te r K a z a k h s ta n M ed ical A d viso r, N eu ro /P sych iatry P o rtfo lio | D ep u ty Q P P V A pril 2023 – Present | A lm aty, K azakhstan
Lead m edical activities for C N S portfolio w ith focus on scientific strategy, stakeholder
engagem ent, and pharm acovigilance com pliance.
K ey R esp o n sib ilities ● D evelop and im plem ent m edical strategy for neuro/psychiatry products
● Provide scientific support to internal and external stakeholders ● Engage w ith KO Ls and healthcare professionals ● R eview and approve m edical and prom otional m aterials ● Support pharm acovigilance and safety activities ● D eliver m edical training for com m ercial team s ● Participate in scientific events and educational initiatives ● Ensure com pliance w ith ethical and regulatory requirem ents S elected C o n trib u tio n s ● Supported lifecycle m anagem ent activities for C N S portfolio
● Strengthened scientific com m unication w ith m edical com m unity ● C ontributed to com pliance and pharm acovigilance excellence ● Supported cross-functional m edical-com m ercial alignm ent
G e d e o n R ic h te r P lc .
R eg u lato ry A ffairs M an ag er | D ep u ty Q P P V January 2015 – M arch 2023 | K azakhstan
M anaged full regulatory lifecycle and pharm acovigilance activities for pharm aceutical
products in Kazakhstan and EAEU environm ent.
K ey R esp o n sib ilities ● Preparation and subm ission of registration dossiers

● Variations, renew als, and lifecycle m anagem ent ● EAEU harm onization subm issions ● R egulatory com m unication w ith health authorities ● D evelopm ent of PV docum entation and SO Ps ● Preparation of R M Ps and safety docum entation ● C oordination of regulatory com pliance activities S elected C o n trib u tio n s ● Independently m anaged registration procedures from dossier preparation to approval
● Supported im plem entation of EAEU regulatory requirem ents ● Participated in developm ent of local pharm acovigilance processes ● Successfully m aintained regulatory com pliance across product portfolio
N a tio n a l C e n te r fo r E x p e rtis e o f M e d ic in e s a n d M e d ic a l
D e v ic e s
L ead in g E xp ert, P h arm aco lo g ical E xp ertise D ep artm en t 2010 – 2015 | K azakhstan
● C onducted pharm acological assessm ent of m edicinal products ● Evaluated registration dossiers and clinical docum entation ● Participated in regulatory review and expert evaluation procedures ● Assessed safety and efficacy data for m edicinal products
A s fe n d iy a ro v K a z a k h N a tio n a l M e d ic a l U n iv e rs ity
H ead o f S cien ce D ep artm en t | A ssistan t P ro fesso r o f P h arm aco lo g y 2003 – 2011 | K azakhstan
● Led academ ic and scientific activities ● C oordinated scientific research projects ● D elivered teaching in pharm acology and clinical pharm acology ● Participated in publication and innovation initiatives
E D U C A T IO N

A s fe n d iy a ro v K a z a k h N a tio n a l M e d ic a l U n iv e rs ity C an d id ate o f M ed ical S cien ces (P h D ) C linical Pharm acology & Pharm acology | 2009 M aster’s D eg ree in H ealth care M an ag em en t 2008 – 2010 D o cto r o f M ed icin e (M D ), P ed iatrics 1994 – 2000

S C IE N T IF IC A C H IE V E M E N T S
● Author and co-author of 40+ scientific publications ● C o-author of 20+ innovation patents ● C o-author of pharm acology textbook for m edical universities ● M em ber of Kazakhstan Association of Pharm acologists and C linical Pharm acologists ● Experience in scientific project defense for M inistry of H ealth and M inistry of
Education

S E L E C T E D T R A IN IN G S &
C E R T IF IC A T IO N S
● IC H G C P ● G ood Pharm acovigilance Practice (G VP) ● G M P / G D P / G SP ● G LP & G C P Inspection Principles ● EAEU R egulatory R equirem ents ● Signal M anagem ent & R isk M anagem ent Planning ● C linical R esearch and Bioethics ● Pharm acovigilance System s & Safety M onitoring
L A N G U A G E S

● Kazakh — N ative ● R ussian — Fluent ● English — W orking proficiency
D IG IT A L & T E C H N IC A L S K IL L S
M S O ffice • Adobe Acrobat • M edical W riting • R egulatory D ocum entation
Scientific C om m unication • Safety D ocum entation • Presentation D evelopm ent P R O F E S S IO N A L S T R E N G T H S
● Strong regulatory authority background ● C om bination of M edical + R egulatory + PV expertise ● Strategic scientific thinking ● H igh-level stakeholder com m unication ● D eep understanding of EAEU regulatory environm ent ● Strong scientific and analytical capabilities