Mgr Drug Safety

Covance (São Paulo SP, Brasil) Publicado 23 dias atrás
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

We are recruiting for our Drug Safety / Pharmaco Vigilance Team and are currently seeking to hire a Manager Drug Safety (Line Manager) This is a permanent, full time position.
This position could be based in Brazil, Bulgaria or Poland.
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.

There is no better time to join us!
Minimum Required:
Level of education required (or experience level which may be substituted for level of education).
Professional designations/certifications/licenses required
♦ Non-degree + 6-7 yrs safety experience*
♦ Associate degree + 5-6 yrs safety experience*
♦ Associate degree RN + 5-6 yrs safety experience*
♦ BS/BA + 4-5 yrs safety experience*
♦ MS/MA + 3-4 yrs relevant experience (2-3 yrs safety experience)
♦ PharmD + 2-3 yrs relevant experience (1-2 yrs safety experience)
For PharmD, a one-year residency of fellowship can be considered relevant experience.
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy,
Nursing, Life Sciences, and Chemistry.
*Safety experience includes actual experience processing AE/SAE reports, generating narratives,
queries, working within safety databases, and experience with regulatory submissions.
Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry,
partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.
EudraVigilance Certification preferred
Advance level of English language
♦ At least 2 years line management and/or project management experience.
♦ Industry experience of which 4 years is relevant to pharmacovigilance/drug safety knowledge.
♦ Good verbal, written and presentation skills.
♦ Ability to interact and influence with line and middle management, staff and external contacts
on a functional and tactical level.
♦ Work collaboratively with PSS Management’s team
♦ Leadership capabilities
♦ Good Communication
♦ High degree of accuracy with attention to detail.
♦ Ensure client and global regulatory compliance.
♦ Will present and share useful business information across departments and functions
♦ Anticipate/identify problems and takes appropriate action to correct.
♦ Knowledge of medical and drug terminology
♦ Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
♦ Knowledge of worldwide regulatory requirements and reporting of adverse event for both
marketed and investigational products
♦ Knowledge of Medical Device Reporting desirable
♦ Knowledge of aggregate reporting desirable
♦ Good keyboard skills, preferably with knowledge of MS office and Windows would be
♦ Financially intuitive
♦ Knowledge of ICH guidelines.
♦ Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
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