International Clinical/Pharmacovigilance Auditor
Roche - San Francisco, CA

This job posting is no longer available on Roche. Find similar jobs: International Clinical Pharmacovigilance Auditor jobs - Roche jobs

Position Purpose:
T he Senior I n t ern a t ional Clinical/Pharmacovigilance Audi t or s uppor t s t he R o c he / Genentech Organi z a t ion by app l y ing in-dep t h k no w l e dge o f Good C lini c al Pra ct i c e (G C P), Pharmacovigilance (PV) and i n t erna t ional regula t ions t o t he aud i t ing pr o c e s s t o independ e n t l y addre s s a v ari e t y of c o m plian c e i ss ues a s s o c i a t ed w i t h drug d e v elop m e n t and drug safety .

M a j o r R es p o n s i b i li t i es a n d A c c o u n ta b i l i t i es

Per f orm and l e ad c o m plex aud i t s in c luding but n o t l i m i t ed t o: i n t ernal clinical s y st e m s , internal safety systems, e x t ernal s e r v i c e pro v ider s , affiliates, marketing partners, licensing distributors, c lin i c al i n v e s t iga t or s i t es and due diligen c e a s s e s sm e n t s

I ndepen d en t l y per f orm all a c t i v i t ies in c luding audit prepara t ion, c ondu c t , pre s e n t a t io n , and t i m e l y repor t ing of audit f indin g s , and e v alua t ion of C APA s .

Pre s ent o b s er v a t ions t o audi t e e s and Phar m a rep r e s en t a t i v es and prepare a w ri t t en aud i t repor t .

Audit report s hould not require m ore t han m ini m al t o m odera t e input f r o m m anager / repo r t re v ie w er.

En s ure appropria t e c orr e ct i v e and pre v e n t a t i v e a c t i ons ha v e been c o m m i t t ed by t he aud i t ees

Par t i c ipa t e in p o s t -aud i t m ee t in g s t o d i sc u s s unre s ol v ed i s s ues w i t h Senior M anage m ent

D e t er m ine a c c ep t abil i t y of e v ide n c e f or C APA i m p l e m en t a t ion

Pro v ide leader s h i p t o s m all aud i t t ea m s f or c o m pl e x s y st e m s aud i t s , d e m on s t ra t ed audi t ing e x per t i s e i n at lea s t tw o area s , d e v elop e x per t i s e in addi t ional ar e as

I den t i f y and report s y st e m a t ic i s s ues be y ond t he indi v idual audit f indin g s a s w ell a s oppo r t uni t ies f or p ro c e s s i m pro v e m e n t s w i t h t he a ss i st a n c e o f m anage m e n t i f needed

M anage ‘ f or c a u s e’, c r i t i c al and or c o m plex quali t y i ss ues m o st ly independ e n t ly

D e v elop audit plan f or no n - s t andard audi t s e . g. c o m plex in t ernal s y st e m s audit

Pro v ide edu c a t ion an d / or t raining t o Clinical and Safety f un ct ion a l areas and c lin i c al oper a t ion t ea m s , m ay a c t as t ra i ner and m en t or f or junior audi t o r s in c l o s e c ollabora t i o n w i t h t heir line m anager

Par t ner w i t h o t her Pha r m a pe r s onnel i n c luding Le g al, R egula t ory A ff air s , Safety, C lini c al Opera t io n s , e t c . r e g a rding c o m plian c e i s s ues

Par t i c ipa t e in or lead depa r tm e n t al or c r o s s - f un c t i o nal c o m plia n c e proj e c t s and ini t i a t i v e s a s a ss igned

Support I n s pe c t ion M anage m e n t T eam in prepara t i on f or and during regul a t ory au t hori t y in s pe ct ions a nd per f orm m o c k i n s pe c t i o ns

A c t a s a Program C on t a c t and de v elop ri s k b a s ed audit plan f or a ss igned area

M ain t ain in-dep t h k no w ledge of c o m pany poli c ie s , SOPs and s uppor t ing do c u m en t s rel a t ed t o drug de v elop m ent and drug safety as w ell as FD A and EU regula t ions a nd IC H guidan c e do c u m e n t s along w i t h any o t her na t ional or in t erna t ional regula t io n s t hat m ay a ff e c t drug d e v elop m ent and drug safety.

Per f orm o t her t a s k s as a s s igned by line m anag e m ent in line w i t h aud i t or s ’ du t i e s

Who you are
In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Because we know that employees are critical to our success in
bringing novel medicines to patients, we are dedicated to remaining a great place to work and to providing employees with programs, services and benefits that allow them to bring the best to the business and to their personal lives.
Q u a l i f i ca t i o n s

Ba c helor’s degree or pr e f erably higher edu c a t ion in a bio m ed i c al / sc ie n t i f i c d i sc ipline w i t h a m in i m um of 7 y ears phar m a c e u t i c a l / bio t e c h ind u st ry and / or c lini c al re s ea r c h e x pe r ien c e

5+ y ears in Quali t y A ss uran c e / 3+ y ears G C P and/or PV audi t ing e x perien c e in an i n t erna t ional en v iron m e n t

Ex p e r i e n ce a n d / o r Co m p et e n c i es R e q u i r ed

E x perien c e, c o m pe t e n c y , and pro v en t r a c k re c ord of c ond u ct ing and leading audi t s a c r o s s audit di s c i plines
I n dep t h k no w ledge o f drug de v elop m e n t and drug safety pr o c e s s e s and G C P/PV regul a t ions
Pro v en re c ord of w o r k ing w i t h c r o s s - f un c t ional t e a m s in an i n t erna t ional en v iro n m ent
Abili t y t o e ff e ct i v ely organi z e and e x e c u t e t a s k s
Abili t y t o w ork bo t h independ e n t ly and in a t eam e n v iron m ent
S t rong anal y t i c al, probl e m s ol v ing and d e c i s ion m a k ing s k ills in a c o m ple x , f a s t p a c ed, and c hanging en v iron m ent
S t rong c o mm un i c a t ion and pr e s en t a t ion s k ill s ; v er b al and w r i tt en
Abili t y t o in f luen c e and neg o t ia t e e f f e ct i v e s olu t io n s , s t rong i n t erper s onal and s o c ial s k ills

The next step is yours. To apply today, click on the "Apply online" button below.
Roche is an Equal Opportunity Employer

Roche - 19 months ago - save job - block
About this company
172 reviews
Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...