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Scientist Job
Eingestellt von Yoh
Gesuchte Skills: Support, Client
Projektbeschreibung
WHAT YOU'LL BE DOING:
- Carrying out pharmacovigilance activities on a product or group of products, including single case processing, aggregate reporting, signal detection and evaluation of PV database.
- The Safety Scientist supports the Safety Science Leader.
- Responsible for a particular aspect(s) or segments of the overall program. He/She contributes to the benefit risk evaluation and to safety risk management.
- Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential Issues.
- Prepare and review periodic safety reports (PSUR, EU Annual Safety Reports) in accordance with regulatory requirements and PDMS standard operating procedures.
- Coordinate safety activities between PDS and internal and external partners.
- Carry out signal detection activities and evaluation:
- Conduct/support signal detection and evaluation according to SOPs and guidelines.
- Carry out medical review of spontaneous case reports and Serious Adverse Event reports from clinical trials, according to SOPs and guidelines.
- Prepare Drug Safety reports, as necessary, for potential signals.
- Respond to queries relevant to the safety of Roche products from the affiliates and other internal functions.
- Contribute drug safety input to activities to define and implement the Clinical Development strategy for a product or group of products:
- Provide review of clinical protocols and study reports to ensure alignment with CDP and safety adequately addressed, and contributes to the safety section of the Investigators Brochure (IB).
- Contribute to regulatory authority submissions (NDAs, MAAs, Variations) by reviewing safety data and preparing relevant sections of the submission.
WHAT YOU NEED TO BRING TO THE TABLE:
- Prior experience in safety is desirable (at least two (2) years).
- MD candidates with solid pharmaceutical experience in clinical development or medical affairs (at least three (3) years).
- Industry experience in drug safety or clinical development.
- Good knowledge of pharmacovigilance practices.
- Good knowledge of US and EU pharmacovigilance regulatory requirements.
- Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions.
- Ability to evaluate, interpret and synthesize scientific data.
- Team player with ability to function in a multi-disciplinary environment.
BONUS POINTS!
- Minimum: MD is preferred PhD, PharmD, Pharm, MS or equivalent qualification and good medical competence in the relevant therapeutic area may be considered.
WHAT ARE YOU WAITING FOR? APPLY NOW!
RECRUITER: Salima Hakim
Yoh, a DayJ2W: CLINICAL
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Ref:
SFSF: LS
Projektdetails
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Einsatzort:
South San Francisco, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges